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At medXteam, clinical data is our core focus. We collect this data through systematic literature searches or directly with the medical device during clinical trials. We already explained how literature searches serve as an interface and how data can be collected digitally in a post last year. We also act as quality management representatives for our clients, developing quality management systems in this context. These systems can also be digitized, which takes us another step further in terms of digitization and automation.

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

eCRF electronic case report form

EDC Electronic Data Capture

Underlying regulations

EU Regulation 2017/745 (MDR)
Medical Devices Implementation Act (MPDG)

1 Introduction

The medical technology industry has undergone a significant digital transformation in recent years. Technologies such as artificial intelligence and the Internet of Things have become driving forces revolutionizing how we develop and use medical devices. This digital shift also has implications for quality management, particularly in the context of medical devices.

Every manufacturer of medical devices is legally obligated to implement, maintain, and continuously improve a compliant quality management system (QMS) in accordance with the requirements of EU Regulation 2017/745 (Medical Device Regulation, MDR) and ISO 13485. This QMS forms a crucial pillar for ensuring both the safety and efficacy of the products and compliance with regulatory requirements and legal provisions.

In this digital era, designing a digital technology environment from our quality management system offers the opportunity to drive innovation, efficiency and sustainable improvements to workflows, providing numerous benefits including optimized efficiency, increased product quality and robust documentation and traceability capabilities.

2. Digitization of literature searches and clinical trials

We successfully implemented the integration of digital technologies over two years ago in the area of literature searches for clinical evaluation as well as for clinical trials according to Articles 62, 74 or 82 of the MDR.

Digital literature searches enable a thorough and efficient collection of relevant clinical data necessary for assessing the safety and performance of a medical device.

Fig. 1 Literature search in the center

Literature searches can sometimes be very time-consuming and lengthy. Therefore, as part of the digitization of technical documentation, clinical evaluation, and in particular the literature search, was also digitized and the process automated.

Since medXteam focuses primarily on clinical data, literature searches are central. We implemented this process through our partner avasis , a certified Smart Expert Partner of Siemens Digital Industries Software in the areas of Teamcenter and Polarion.

Digitizing clinical trials improves data collection, analysis, and reporting, ultimately leading to more reliable results and more efficient processes. Our MaganaMed EDC system offers precisely this through the implementation of electronic clinical trial reports (eCRFs).

The close integration of clinical trials (whether for approval, within the framework of clinical evaluation, for the collection of product-specific data after market launch, or within the framework of a DiGA study) with the literature search process and thus with the clinical evaluation also necessitates the digitization of essential clinical trial documents such as...

Clinical trial plan (Appendix XV, Chapter II, Section 3 of the MDR)
Clinical Investigator's Manual (Appendix XV, Chapter II, Section 2 of the MDR)
preclinical assessment

possible.

These digital approaches have proven extremely valuable and are setting new standards for transparency, efficiency, and accuracy. However, the impact of digitalization extends far beyond these areas. In a regulated environment such as medical technology, digitalization offers the opportunity to improve just as many aspects of quality management.

3. Digitalization in quality management

3.1 Advantages and necessity of digitizing quality management

Digital literature searches and clinical trials are essential components of today's research and development process in medical technology. They improve the efficiency and quality of data collection, analysis, and reporting. However, digitalization goes even further and significantly influences quality management.

It also offers numerous advantages: It improves process efficiency, thereby increasing the quality of medical devices and enabling better traceability and documentation. It also allows for more efficient QMS management. This is crucial for complying with the requirements of ISO 13485 and the MDR.

A digitized QMS enables seamless and centralized document management, more efficient and transparent auditing, and improved risk and process management. All these aspects are crucial for ensuring not only compliance with requirements but also the high quality of medical devices.

3.2 orgavision and the digitalization of quality management

In the rapidly changing world of medical technology, the digitalization of quality management is more than just an option – it's a necessity. With the right tools, medical device manufacturers can streamline their processes, improve their compliance, and ultimately deliver better products for patients.

One example of a tool for digitizing quality management is orgavision. This tool offers a wide range of functions that contribute to the digitization of quality management systems.

Orgavision enables companies to digitize and automate their quality management, leading to improved compliance and ultimately higher quality medical products.

Orgavision is a good example of a tool that supports the digitization of quality management systems. Orgavision's functions range from integrated digital document management to a comprehensive event management system (e.g., customer feedback, complaints, corrective and preventive actions).

Particularly noteworthy is orgavision's automation feature. One example is the automatic updating of process names. If a process name is changed in orgavision, this name is automatically updated in all documents where the process is explicitly linked. This avoids inconsistencies and misinformation, improving the accuracy and reliability of the documentation.

Orgavision also offers efficient audit management. Audits can be planned, conducted, and monitored, and the results can be easily integrated into the system and analyzed. This facilitates compliance with regulatory requirements and improves the efficiency of the auditing process.

orgavision is therefore a pioneering software solution specifically developed for the digitization and automation of quality management systems (QMS) in the medical field. It offers a wide range of functions that support the entire QMS process and contribute to increased efficiency. The following are further features of orgavision:

Change management: orgavision enables efficient change management by providing a structured process for handling change requests, approvals, and implementations. Digitizing this process allows changes to be quickly captured, tracked, and documented, improving control and efficiency.

Complaint Management: This tool offers features for effectively handling customer complaints. This includes recording, categorizing, and processing complaints, as well as tracking corrective actions. By digitizing complaint management, companies can respond more quickly to customer feedback, process complaints efficiently, and ensure continuous improvement in product quality.

Training: Orgavision enables the efficient digitization and optimization of training processes. The training matrix provides a comprehensive overview of the training requirements and current training status of all employees. You can define individual training elements, such as training events, courses, or webinars, for different employees or employee groups.

Let us now present this example in more detail:

Fig. 2 Training matrix orgavision

Each training course can be linked to relevant competencies, departments, or defined roles. This makes it possible to precisely identify which training courses are required for which employees and at what intervals. This systematic and structured approach ensures that no employee misses out on necessary training and that all employees always possess the required knowledge and skills.

Orgavision also offers the option of linking and managing training certificates directly within the system. Upon completion of a training course, relevant documents, such as certificates or confirmations, can be uploaded directly to the system and assigned to the appropriate employees.

These certificates are then accessible at any time and can be exported from the system if needed. Linking the training certificates not only simplifies the documentation and management of training courses, but also the verification of the training level of individual employees or entire teams.

4. Conclusion

The advantages of digitalization as a whole are obvious:

more efficient work
Target-oriented use of capacities
Elimination of inefficiencies in the creation, maintenance and modification of content for technical documentation, clinical evaluation and literature searches, as well as in the area of quality management
Avoiding redundantly managed information/documents
long-term reduction in care costs

By using digital tools like orgavision, companies can improve their quality management processes while ensuring their compliance.

The aforementioned functions of orgavision enable comprehensive digitization and automation of the QMS. This leads to improved efficiency, accuracy, and compliance. Centralized document management, workflow and process automation, and the digitization of change management, complaint management, and supplier management help optimize quality management processes and meet the requirements of ISO 13485 and the MDR.

In summary, digitalization in quality management absolutely simplifies processes, eliminates redundancies, and is therefore an absolute necessity in the long run. With the right tools and strategies, digitalization of quality management can lead to more efficient processes, improved compliance, and ultimately, higher-quality products.

5. What we can do for you

If a clinical trial is to be carried out, basic safety and performance requirements must first be met, and therefore essential technical documentation must be prepared.

Furthermore, all manufacturers of medical devices require a QMS, even when developing Class I products.

The clinical trial culminates in the clinical evaluation, which then in turn forms the basis for PMCF activities (including a PMCF study).

Therefore, we support you throughout your entire project with your medical device, always with primary reference to the clinical data on the product: from the beginning to the end.

6. How we can help you

At medXteam we clarify whether and if so which clinical trial needs to be carried out under what conditions and according to what requirements during the pre-study phase: In 3 steps we determine the correct and cost-effective strategy in relation to the clinical trial required in your case Data collection.

We also provide support in the areas of development strategy, technical documentation and quality management.

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation

This year's blog series continues during Advent with our three-part "Advent Special." In this series, we aim to provide you with comprehensive information on the important interfaces between the various types of clinical trials and their technical documentation, as well as the relevant documents.

What's special about our campaign is that the content is spread over the first three weeks of Advent. Each week, we'll take a detailed look at one type of clinical trial and its respective interfaces. In January, we'll continue with the topic of risk management in clinical trials.

The first part of our blog special dealt with the interfaces in the "registration study" (clinical trials according to Article 62 of the MDR). This second part now examines PMCF studies (Article 74 of the MDR, MPDG, ISO 14155). The third and final part, to be published next week, will explain the interfaces in DiGA studies.

Abbreviations.

BOB (higher federal authority)

EK (Ethics Commission)

KP (clinical examination)

MDR (medical device regulation; Regulation 2017/745)

The Medical Devices EU Adaptation Act (MPEUAnpG) was passed by the German Bundestag on May 25, 2020. Article 1 of this MPAnpG-EU describes the Medical Devices Implementation Act (MPDG).

MPDG (the MPDG will gradually replace the Medical Devices Act (MPG) from May 26, 2021 and will be legally binding for all manufacturers and operators of medical devices in Germany).

Part 2: Interfaces to technical documentation in PMCF studies and connection to the MDR

1 Introduction

The correct term for a clinical trial involving medical devices is “clinical trial”.

A distinction is made between the following types of clinical trials:

Basic research: other clinical trials (MDR Article 82)
Pilot study/approval study: clinical trials to demonstrate the conformity of products (MDR Article 62)
PMCF study: clinical trials related to products bearing the CE marking (MDR Article 74)

In addition, there is now the so-called DiGA study, especially in Germany:

Study with a digital health application (DiGA) to demonstrate positive care effects in order to obtain reimbursement status.
d. R. with CE marked medical device: PMCF study
If planned into the approval process, an approval study is also possible

(Sources: DiGAV, DVG, DiGA guidelines)

Fig. 1: Types of clinical trials

These different types differ in terms of the respective regulatory requirements and thus in terms of the different interfaces to the technical documentation of the medical device to be examined.

Special feature of PMCF studies:

A PMCF study conducted with a CE-marked medical device within the scope of its intended purpose and without invasive examinations constitutes an exception to Article 74 of the MDR:

Figure 4: Article 74 of the MDR (Source: Presentation slides, BfArM event, https://www.bfarm.de/DE/Service/Veranstaltungen/Dialogveranstaltungen/2021/210505-klinische_Pruefungen_von_MP.html)

However, regardless of this, the documents in Annex XV Chapter II and Articles 80ff of the MDR are still binding.

2. Documents to be submitted for PMCF studies

The following documents must be prepared for clinical trials involving a CE-marked product. Depending on whether Article 74 of the MDR applies, the application is submitted to the Ethics Committee for a vote and to the Federal Institute for Drugs and Medical Devices (BfArM). If Article 74 does not apply, only professional consultation with the relevant ethics committee is required, in accordance with Section 15 of the Professional Code of Conduct for Physicians (BO). Regardless of the application procedure, the following documents must be prepared and relate to the technical documentation:

Test plan - attachments according to appendix XV chapter. II 3 MDR.
Clinical Investigator's Handbook -Annexes according to Annex XV Chapter II 2 MDR.

The following documents from the technical documentation are required for this purpose:

Clinical evaluation - in accordance with Article 61 of the MDR.
Instructions for use
Biological safety test results
MP Functionality/Information about MP (How MP Works)
How it works and further information about the medical device.
Risk analysis and assessment including residual risks
List basic security and performance requirements
If necessary, suitable processing or sterilization processes
Proof of CE marking (Required if the test product bears a CE marking.)

2.1 Interfaces to technical documentation

The following table lists the above-mentioned documents to be submitted as well as the elements contained therein and the respective correspondence in the technical documentation:

document	Regulatory requirement	elements	Technical Documentation
Test plan	Appendix XV Ch. II 3 MDR	Labeling and description of the product, including the intended purpose, manufacturer, traceability, target group, materials in contact with the human body, medical and surgical procedures associated with its use and the training and experience required for its use, triage the reference literature, the current state of the art in clinical care in the relevant area	Product description, intended purpose, product specification, preclinical evaluation as a preliminary stage of the final clinical evaluation with state of the art chapter, instructions for use with description of the application
Test plan	Appendix XV Ch. II 3 MDR	Risks and clinical benefits of the product under test	Risk analysis, risk management report, preclinical assessment with risk-benefit assessment
Test plan	Appendix XV Ch. II 3 MDR	Information about the test product, any comparators and other products	Product description, instructions for use
Test plan	Appendix XV Ch. II 3 MDR	technical and functional characteristics of the product	Product description, instructions for use, product specification
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	Labeling and description of the device, including information on the intended purpose, risk classification and applicable classification rule in accordance with Annex VIII, design and manufacture of the device and reference to previous and similar generations of the device.	Product description, intended purpose, product specification, preclinical evaluation as a preliminary stage of the final clinical evaluation with state of the art chapter, instructions for use with description of the application Classification
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	Manufacturer's information on installation, maintenance, compliance with hygiene standards and use, including storage and handling requirements, and, where this information is available, the information to be included on the label and the instructions for use to be provided with the product when it is placed on the market.	--
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Preclinical assessment based on data from relevant preclinical tests and experiments, in particular from design calculations, in vitro tests, ex vivo tests, animal experiments, mechanical or electrical tests, reliability tests, sterilization validations, software verifications and validations, performance tests, evaluations biocompatibility and biosafety, where applicable.	Preclinical assessment as a preliminary stage of the final clinical assessment
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Existing clinical data, in particular — from the relevant available scientific literature on safety, performance, clinical benefit to patients, design features and intended purpose of the device and/or similar or similar products, — other relevant available clinical data on safety, performance, clinical benefit for the patients, design characteristics and intended purpose of similar or similar devices from the same manufacturer, including the length of time the device has been on the market, as well as the data from a review of performance and safety aspects and clinical utility and any corrective actions taken.	Preclinical assessment as a preliminary stage of the final clinical assessment
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings.	Instructions for use, preclinical evaluation as a preliminary stage of the final clinical evaluation
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	For products containing a medicinal product, including a derivative of human blood or plasma, or for products manufactured using non-viable tissues or cells of human or animal origin or their derivatives.	Only in this case: Information about the medicinal product or the tissues, the cells or their derivatives and the fulfillment of the relevant essential safety and performance requirements and the specific risk management relating to the medicinal product or the tissues or cells or their derivatives and evidence of the incorporation of these components the clinical benefit and/or safety of the product
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	A list detailing compliance with the relevant essential safety and performance requirements set out in Annex I, including the standards and specifications applied, in whole or in part, and a description of the solutions chosen to meet the relevant essential safety and performance requirements, where applicable these standards and specifications are only partially or not at all fulfilled or are completely missing.	Checklist of basic performance and security requirements List of standards
Instructions for use	Appendix XV Ch. II 2.2 MDR	--	Instructions for use
Insurance basic safety and performance requirements	Annex XV Chapter II 4.1 MDR	Assurance that basic safety and performance requirements are met.	Checklist of basic performance and security requirements
Biological safety test results	Appendix XV Ch. II 2.3 MDR	Data from relevant preclinical tests and trials, in particular biocompatibility and biosafety assessments, where applicable.	Test reports, biosafety report
How the MP works/information about the MP	--	How it works and further information about the medical device	Product description, instructions for use, product specification
Risk analysis and assessment including residual risks	Appendix XV Ch. II 2.5 or 4.6 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings. Full details of the available technical documentation, for example detailed risk analysis/management documents or specific test reports, will be provided upon request to the competent authority reviewing an application.	Risk management documentation according to ISO 14971
List basic security and performance requirements	Appendix XV Ch. II 2.7 MDR	--	Checklist of basic performance and security requirements
If necessary, suitable processing or sterilization processes	--	Sterilization process, validation	Documentation of the sterilization process

Table 1: Clinical trial documents and technical documentation

Since this is a CE-marked product, all these documents are already included in the technical documentation and are incorporated in particular into the study plan and the clinical investigator's manual.

The CE-marked medical device is therefore the investigational product tested in the PMCF study, for which the clinical data are collected. This means that the documents and results must refer to precisely this product and not to a previous version!

Technical Documentation:

Product description
Intended use
product specification
final clinical evaluation with state of the art chapter and literature review and risk-benefit analysis
Risk management documentation according to ISO 14971: PHA, risk analysis, risk management report
Instructions for use
Classification
Checklist of basic performance and security requirements
List of standards
Verification test reports
Biosafety report (if applicable)
Sterilization process documentation (if applicable)

2.2 Synergies

Looking at the list above, it is noticeable that this already constitutes almost the entire technical documentation.

A good example of leveraging synergies in document creation is the study protocol. Many sections contain the same content as other technical documentation documents. The intended purpose, product description, etc., are just a few examples. Furthermore, the final clinical evaluation includes state-of-the-art clinical data that can also be used for the study protocol and the investigator's manual.

And here the digitalization of clinical trials plays a role again:

The close integration of clinical trials not only with the literature search process and thus with clinical evaluation, as reported in the penultimate blog post, but also with technical documentation, necessitates the digitization of essential clinical trial documents such as...

Clinical trial plan (Appendix XV, Chapter II, Section 3 of the MDR)
Clinical Investigator's Manual (Appendix XV, Chapter II, Section 2 of the MDR)
clinical evaluation

possible.

The advantages of digitalization are obvious:

more efficient work
Target-oriented use of capacities
Elimination of inefficiencies in the creation, maintenance and modification of technical documentation content, clinical evaluation and literature searches
long-term reduction in care costs

The "Polarion" software application allows interfaces such as intended purpose, risk management, usability, clinical evaluation, and clinical trials to be assigned to projects and reused as needed. This significantly simplifies and accelerates the creation and maintenance of documents. Furthermore, redundancies and inconsistencies are avoided.

3. Outlook

Our “Adventspecial” next week will focus on the interfaces to technical documentation in DiGA studies.

4. How we can help you

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation

The first part of our blog special dealt with the interfaces in the "registration study" (clinical trials according to Article 62 of the MDR). Part 2 now examines PMCF studies (Article 74 of the MDR, MPDG, ISO 14155). This third and final part now explains the interfaces in DiGA studies.

Abbreviations.

BOB (higher federal authority)

EK (Ethics Commission)

KP (clinical examination)

MDR (medical device regulation; Regulation 2017/745)

The Medical Devices EU Adaptation Act (MPEUAnpG) was passed by the German Bundestag on May 25, 2020. Article 1 of this MPAnpG-EU describes the Medical Devices Implementation Act (MPDG).

MPDG (the MPDG will gradually replace the Medical Devices Act (MPG) from May 26, 2021 and will be legally binding for all manufacturers and operators of medical devices in Germany).

Part 2: Interfaces to technical documentation in PMCF studies and connection to the MDR

1 Introduction

The correct term for a clinical trial involving medical devices is “clinical trial”.

A distinction is made between the following types of clinical trials:

Basic research: other clinical trials (MDR Article 82)
Pilot study/approval study: clinical trials to demonstrate the conformity of products (MDR Article 62)
PMCF study: clinical trials related to products bearing the CE marking (MDR Article 74)

In addition, there is now the so-called DiGA study, especially in Germany:

Study with a digital health application (DiGA) to demonstrate positive care effects in order to obtain reimbursement status.
d. R. with CE marked medical device: PMCF study
If planned into the approval process, an approval study is also possible

(Sources: DiGAV, DVG, DiGA guidelines)

Fig. 1: Types of clinical trials

These different types differ in terms of the respective regulatory requirements and thus in terms of the different interfaces to the technical documentation of the medical device to be examined.

A DiGA study is a PMCF study. Therefore, the same special features apply:

A DiGA and thus PMCF study, which takes place with a CE-marked medical device within the scope of its intended purpose and without burdensome examinations, constitutes an exception to Article 74 of the MDR:

Figure 4: Article 74 of the MDR (Source: Presentation slides, BfArM event, https://www.bfarm.de/DE/Service/Veranstaltungen/Dialogveranstaltungen/2021/210505-klinische_Pruefungen_von_MP.html)

However, regardless of this, the documents in Annex XV Chapter II and Articles 80ff of the MDR are still binding.

2. Documents to be submitted for DiGA studies

The additional phase in a DiGA study includes creating the evaluation concept based on a systematic literature search, data collection with the DiGA itself on the user, and the systematic evaluation of this data.

The clinical evaluation – and in this case, preferably the most recently completed one – serves as essential input for this purpose. It lists the various claims for the medical device, and the appropriate ones for the DiGA concept must be identified from these claims. Furthermore, the claims required for the clinical evaluation regarding clinical performance, safety, and clinical benefit were already defined in the clinical evaluation plan and subsequently substantiated with data in the clinical evaluation report.

Note: This is precisely where the use of the interface to the DiGA topic "medical benefit" or patient-relevant structural and procedural improvements is recommended, because this data can then be used in the update of the clinical assessment after the DiGA study.

We have already reported on this in detail in our blog post about the evaluation concept this year.

Following the development of the evaluation concept and the identification of suitable endpoints for the DiGA study, the next step is the creation of the study documents. As with the PMCF study, the following documents must also be prepared for DiGA studies. Depending on whether Article 74 of the MDR applies, the application is submitted to the Ethics Committee for a vote and to the Federal Institute for Drugs and Medical Devices (BfArM). If Article 74 does not apply, only professional consultation with the relevant ethics committee is required, in accordance with Section 15 of the Professional Code of Conduct for Physicians (BO). Regardless of the application procedure, the following documents must be prepared, and these relate to the technical documentation:

Test plan - attachments according to appendix XV chapter. II 3 MDR.
Clinical Investigator's Handbook -Annexes according to Annex XV Chapter II 2 MDR.

The following documents from the technical documentation are required for this purpose:

Clinical evaluation - in accordance with Article 61 of the MDR.
Instructions for use
Biological safety test results
MP Functionality/Information about MP (How MP Works)
How it works and further information about the medical device.
Risk analysis and assessment including residual risks
List basic security and performance requirements
If necessary, suitable processing or sterilization processes
Proof of CE marking (Required if the test product bears a CE marking.)

2.1 Interfaces to technical documentation

The following table lists the above-mentioned documents to be submitted as well as the elements contained therein and the respective correspondence in the technical documentation:

document	Regulatory requirement	elements	Technical Documentation
Test plan	Appendix XV Ch. II 3 MDR	Labeling and description of the product, including the intended purpose, manufacturer, traceability, target group, materials in contact with the human body, medical and surgical procedures associated with its use and the training and experience required for its use, triage the reference literature, the current state of the art in clinical care in the relevant area	Product description, intended purpose, product specification, preclinical evaluation as a preliminary stage of the final clinical evaluation with state of the art chapter, instructions for use with description of the application
Test plan	Appendix XV Ch. II 3 MDR	Risks and clinical benefits of the product under test	Risk analysis, risk management report, preclinical assessment with risk-benefit assessment
Test plan	Appendix XV Ch. II 3 MDR	Information about the test product, any comparators and other products	Product description, instructions for use
Test plan	Appendix XV Ch. II 3 MDR	technical and functional characteristics of the product	Product description, instructions for use, product specification
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	Labeling and description of the device, including information on the intended purpose, risk classification and applicable classification rule in accordance with Annex VIII, design and manufacture of the device and reference to previous and similar generations of the device.	Product description, intended purpose, product specification, preclinical evaluation as a preliminary stage of the final clinical evaluation with state of the art chapter, instructions for use with description of the application Classification
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	Manufacturer's information on installation, maintenance, compliance with hygiene standards and use, including storage and handling requirements, and, where this information is available, the information to be included on the label and the instructions for use to be provided with the product when it is placed on the market.	--
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Preclinical assessment based on data from relevant preclinical tests and experiments, in particular from design calculations, in vitro tests, ex vivo tests, animal experiments, mechanical or electrical tests, reliability tests, sterilization validations, software verifications and validations, performance tests, evaluations biocompatibility and biosafety, where applicable.	Preclinical assessment as a preliminary stage of the final clinical assessment
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Existing clinical data, in particular — from the relevant available scientific literature on safety, performance, clinical benefit to patients, design features and intended purpose of the device and/or similar or similar products, — other relevant available clinical data on safety, performance, clinical benefit for the patients, design characteristics and intended purpose of similar or similar devices from the same manufacturer, including the length of time the device has been on the market, as well as the data from a review of performance and safety aspects and clinical utility and any corrective actions taken.	Preclinical assessment as a preliminary stage of the final clinical assessment
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings.	Instructions for use, preclinical evaluation as a preliminary stage of the final clinical evaluation
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	For products containing a medicinal product, including a derivative of human blood or plasma, or for products manufactured using non-viable tissues or cells of human or animal origin or their derivatives.	Only in this case: Information about the medicinal product or the tissues, the cells or their derivatives and the fulfillment of the relevant essential safety and performance requirements and the specific risk management relating to the medicinal product or the tissues or cells or their derivatives and evidence of the incorporation of these components the clinical benefit and/or safety of the product
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	A list detailing compliance with the relevant essential safety and performance requirements set out in Annex I, including the standards and specifications applied, in whole or in part, and a description of the solutions chosen to meet the relevant essential safety and performance requirements, where applicable these standards and specifications are only partially or not at all fulfilled or are completely missing.	Checklist of basic performance and security requirements List of standards
Instructions for use	Appendix XV Ch. II 2.2 MDR	--	Instructions for use
Insurance basic safety and performance requirements	Annex XV Chapter II 4.1 MDR	Assurance that basic safety and performance requirements are met.	Checklist of basic performance and security requirements
Biological safety test results	Appendix XV Ch. II 2.3 MDR	Data from relevant preclinical tests and trials, in particular biocompatibility and biosafety assessments, where applicable.	Test reports, biosafety report
How the MP works/information about the MP	--	How it works and further information about the medical device	Product description, instructions for use, product specification
Risk analysis and assessment including residual risks	Appendix XV Ch. II 2.5 or 4.6 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings. Full details of the available technical documentation, for example detailed risk analysis/management documents or specific test reports, will be provided upon request to the competent authority reviewing an application.	Risk management documentation according to ISO 14971
List basic security and performance requirements	Appendix XV Ch. II 2.7 MDR	--	Checklist of basic performance and security requirements
If necessary, suitable processing or sterilization processes	--	Sterilization process, validation	Documentation of the sterilization process

Table 1: Clinical trial documents and technical documentation

Technical Documentation:

Product description
Intended use
product specification
final clinical evaluation with state of the art chapter and literature review and risk-benefit analysis
Risk management documentation according to ISO 14971: PHA, risk analysis, risk management report
Instructions for use
Classification
Checklist of basic performance and security requirements
List of standards
Verification test reports
Biosafety report (if applicable)
Sterilization process documentation (if applicable)

2.2 Synergies

Looking at the list above, it is noticeable that this already constitutes almost the entire technical documentation.

And here the digitalization of clinical trials plays a role again:

Clinical trial plan (Appendix XV, Chapter II, Section 3 of the MDR)
Clinical Investigator's Manual (Appendix XV, Chapter II, Section 2 of the MDR)
clinical evaluation

possible.

The advantages of digitalization are obvious:

more efficient work
Target-oriented use of capacities
Elimination of inefficiencies in the creation, maintenance and modification of technical documentation content, clinical evaluation and literature searches
long-term reduction in care costs

3. Outlook

Our "AdventSpecial" has now come to an end. We wish all our readers a peaceful and relaxing Christmas and plenty of time to do something other than deal with medical products.

In the new year, we will resume with the topic of "Risk management in clinical trials".

4. How we can help you

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation

This year's blog series continues during Advent with our three-part "Advent Special." In this series, we aim to provide you with comprehensive information on the important interfaces between the various types of clinical trials and their technical documentation, as well as the relevant documents.

What's special about our campaign is that the content is spread over the first three weeks of Advent. Each week, we'll take a detailed look at one type of clinical trial and its respective interfaces . In January, we'll continue with the topic of risk management in clinical trials.

The first part of our blog special now presents the interfaces in the “approval study” (clinical trials in accordance with Article 62 of the MDR). Part 2 then highlights the PMCF studies (Article 74 of the MDR, MPDG, ISO 14155) and the third and final part explains the interfaces in DiGA studies .

Abbreviations.

BOB (higher federal authority)

EK (Ethics Commission)

KP (clinical examination)

MDR (medical device regulation; Regulation 2017/745)

The Medical Devices EU Adaptation Act (MPEUAnpG) was passed by the German Bundestag on May 25, 2020. Article 1 of this MPAnpG-EU describes the Medical Devices Implementation Act (MPDG).

MPDG (the MPDG will gradually replace the Medical Devices Act (MPG) from May 26, 2021 and will be legally binding for all manufacturers and operators of medical devices in Germany).

Part 1: Interfaces to technical documentation in clinical trials as part of the conformity procedure (approval studies) - Article 62 paragraph 1 MDR

1 Introduction

The correct term for a clinical trial involving medical devices is “clinical trial”.

A distinction is made between the following types of clinical trials:

Basic research: other clinical trials (MDR Article 82)
Pilot study/approval study: clinical trials to demonstrate the conformity of products (MDR Article 62)
PMCF study: clinical trials related to products bearing the CE marking (MDR Article 74)

In addition, there is now the so-called DiGA study, especially in Germany:

Study with a digital health application (DiGA) to demonstrate positive care effects in order to obtain reimbursement status.
d. R. with CE marked medical device: PMCF study
If planned into the approval process, an approval study is also possible

(Sources: DiGAV, DVG, DiGA guidelines)

Fig. 1: Types of clinical trials

These different types differ in terms of the respective regulatory requirements and thus in terms of the different interfaces to the technical documentation of the medical device to be examined.

2. Documents to be submitted for approval studies

The following documents must be submitted for clinical trials in accordance with Article 62 of the MDR and are related to the technical documentation:

Test plan - attachments according to appendix XV chapter. II 3 MDR.
Clinical Investigator's Handbook - Annexes according to Annex XV Chapter II 2 MDR.
Preclinical assessment - systems according to Annex XV Chapter. II 2.3 MDR.
Instructions for use - Appendices in accordance with Annex XV Chapter. II 2.2 MDR.
Assessment of risks - investments in accordance with Annex XV Chapter. II 2.5 or 4.6 MDR.
Insurance basic safety and performance requirements (Insurance Basic Requirements) - Annexes in accordance with Annex XV Chapter II 4.1 MDR.
Results of biological safety testing - facilities in accordance with Annex XV Chapter. II 2.3 MDR.
Proof of safety-related harmlessness - systems in accordance with Annex XV Chapter. II 2.5 or 4.6 MDR.
How the MP works/information about the MP (how the MP works) - systems in accordance with appendix XV chap. II 2.2. MDR.
How it works and further information about the medical device.
Risk analysis and assessment including residual risks - investments in accordance with Annex XV Chapter. II 2.5 or 4.6 MDR.
List of basic safety and performance requirements - systems in accordance with Annex XV Chapter. II 2.7 MDR.
If necessary, suitable processing or sterilization processes
Proof of CE marking (Required if the test product bears a CE marking.)
Clinical evaluation plan - appendices in accordance with Annex XV Chapter II 1.5 MDR;
Technical documentation - systems in accordance with Annex XV Chapter II 3.18 and 4.6 MDR on request

The last point (appendices in accordance with Annex XV Chapter II 3.18 and 4.6 MDR) must only be submitted upon request and includes:

List of technical and functional characteristics of the product, with particular reference to those to which the test relates.
Full details of the available technical documentation, for example detailed risk analysis/management documents or specific test reports, will be provided upon request to the competent authority reviewing an application.

2.1 Interfaces to technical documentation

The following table lists the above-mentioned documents to be submitted as well as the elements contained therein and the respective correspondence in the technical documentation:

document	Regulatory requirement	elements	Technical Documentation
Test plan	Appendix XV Ch. II 3 MDR	Labeling and description of the product, including the intended purpose, manufacturer, traceability, target group, materials in contact with the human body, medical and surgical procedures associated with its use and the training and experience required for its use, triage the reference literature, the current state of the art in clinical care in the relevant area	Product description, intended purpose, product specification, preclinical evaluation as a preliminary stage of the final clinical evaluation with state of the art chapter, instructions for use with description of the application
Test plan	Appendix XV Ch. II 3 MDR	Risks and clinical benefits of the product under test	Risk analysis, risk management report, preclinical assessment with risk-benefit assessment
Test plan	Appendix XV Ch. II 3 MDR	Information about the test product, any comparators and other products	Product description, instructions for use
Test plan	Appendix XV Ch. II 3 MDR	technical and functional characteristics of the product	Product description, instructions for use, product specification
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	Labeling and description of the device, including information on the intended purpose, risk classification and applicable classification rule in accordance with Annex VIII, design and manufacture of the device and reference to previous and similar generations of the device.	Product description, intended purpose, product specification, preclinical evaluation as a preliminary stage of the final clinical evaluation with state of the art chapter, instructions for use with description of the application Classification
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	Manufacturer's information on installation, maintenance, compliance with hygiene standards and use, including storage and handling requirements, and, where this information is available, the information to be included on the label and the instructions for use to be provided with the product when it is placed on the market.
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Preclinical assessment based on data from relevant preclinical tests and experiments, in particular from design calculations, in vitro tests, ex vivo tests, animal experiments, mechanical or electrical tests, reliability tests, sterilization validations, software verifications and validations, performance tests, evaluations biocompatibility and biosafety, where applicable.	Preclinical assessment as a preliminary stage of the final clinical assessment
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Existing clinical data, in particular — from the relevant available scientific literature on safety, performance, clinical benefit to patients, design features and intended purpose of the device and/or similar or similar products, — other relevant available clinical data on safety, performance, clinical benefit for the patients, design characteristics and intended purpose of similar or similar devices from the same manufacturer, including the length of time the device has been on the market, as well as the data from a review of performance and safety aspects and clinical utility and any corrective actions taken.	Preclinical assessment as a preliminary stage of the final clinical assessment
Clinical Investigator Manual/Preclinical Assessment	Appendix XV Ch. II 2.3 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings.	Instructions for use, preclinical evaluation as a preliminary stage of the final clinical evaluation
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	For products containing a medicinal product, including a derivative of human blood or plasma, or for products manufactured using non-viable tissues or cells of human or animal origin or their derivatives.	Only in this case: Information about the medicinal product or the tissues, the cells or their derivatives and the fulfillment of the relevant essential safety and performance requirements and the specific risk management relating to the medicinal product or the tissues or cells or their derivatives and evidence of the incorporation of these components the clinical benefit and/or safety of the product
Clinical Investigator Handbook	Appendix XV Ch. II 2 MDR	A list detailing compliance with the relevant essential safety and performance requirements set out in Annex I, including the standards and specifications applied, in whole or in part, and a description of the solutions chosen to meet the relevant essential safety and performance requirements, where applicable these standards and specifications are only partially or not at all fulfilled or are completely missing.	Checklist of basic performance and security requirements List of standards
Instructions for use	Appendix XV Ch. II 2.2 MDR	--	Instructions for use
Assessment of risks	Appendix XV Ch. II 2.5 or 4.6 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings. Full details of the available technical documentation, for example detailed risk analysis/management documents or specific test reports, will be provided upon request to the competent authority reviewing an application.	Risk management documentation according to ISO 14971
Insurance basic safety and performance requirements	Annex XV Chapter II 4.1 MDR	Assurance that basic safety and performance requirements are met.	Checklist of basic performance and security requirements
Biological safety test results	Appendix XV Ch. II 2.3 MDR	Data from relevant preclinical tests and trials, in particular biocompatibility and biosafety assessments, where applicable.	Test reports, biosafety report
Proof of safety-related harmlessness	Appendix XV Ch. II 2.5 or 4.6 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings. Full details of the available technical documentation, for example detailed risk analysis/management documents or specific test reports, will be provided upon request to the competent authority reviewing an application.	Risk management documentation according to ISO 14971
How the MP works/information about the MP	--	How it works and further information about the medical device	Product description, instructions for use, product specification
Risk analysis and assessment including residual risks	Appendix XV Ch. II 2.5 or 4.6 MDR	Summary of the benefit-risk analysis and risk management, including information on known or foreseeable risks, any undesirable side effects, contraindications and warnings. Full details of the available technical documentation, for example detailed risk analysis/management documents or specific test reports, will be provided upon request to the competent authority reviewing an application.	Risk management documentation according to ISO 14971
List basic security and performance requirements	Appendix XV Ch. II 2.7 MDR	--	Checklist of basic performance and security requirements
If necessary, suitable processing or sterilization processes	--	Sterilization process, validation	Documentation of the sterilization process
Clinical evaluation plan	Annex XV Chapter II 1.5 MDR	--	Clinical Evaluation Plan (CEP)
Technical Documentation	Annex XV Chapter II 3.18 and 4.6 MDR on request	List of technical and functional characteristics of the product. Full details of available technical documentation, for example detailed risk analysis/management documents or specific test reports, provided upon request.	Product description, instructions for use, product specification Risk management documentation according to ISO 14971 Verification test reports

Table 1: Clinical trial documents and technical documentation

This table therefore shows that the following documents from the technical documentation must be prepared for the final medical device even before applying for the clinical trial. The final medical device is thus the investigational product tested in the clinical trial, for which the clinical data are collected. This means that the documents and results must refer precisely to this product and not to a prototype!

Technical Documentation:

Product description
Intended use
product specification
Clinical Evaluation Plan (CEP)
Preclinical assessment as a preliminary stage of the final clinical assessment with state of the art chapters and literature and risk-benefit assessment
Risk management documentation according to ISO 14971: PHA, risk analysis, risk management report
Instructions for use
Classification
Checklist of basic performance and security requirements
List of standards
Verification test reports
Biosafety report (if applicable)
Sterilization process documentation (if applicable)

Only in the case of medical devices that contain drugs or tissues, cells or derivatives, detailed information, which is also contained in the technical documentation, must the following information also be provided:

Information about the medicinal product or the tissues, the cells or their derivatives and the fulfillment of the relevant essential safety and performance requirements and the specific risk management relating to the medicinal product or the tissues or cells or their derivatives and evidence of the incorporation of these components the clinical benefit and/or safety of the product.

2.2 Synergies

If you look at the documentation that must be created before applying for a clinical trial in accordance with Article 62 of the MDR, you will notice that this is almost the entire technical documentation. And that is intentional, because the clinical test is already part of the validation of the final product, so the requirements must already have been checked. Additionally, the product must be proven safe before it is used on humans. I.e. All basic performance and safety requirements are met except for those examined in the clinical trial.

A good example of using synergies when creating documents is the test plan. Many sections contain the same content as in other technical documentation documents. The intended purpose, the product description, etc. are just a few examples. In addition, clinical data on the state of the art are already listed in a so-called preclinical assessment (a document that contains the chapters of the clinical assessment except for the clinical data on the product and PMS etc.), which are also used for the test plan and the clinical examiner's manual can be used.

Such a preclinical assessment can also be part of the clinical investigator's manual, although it is advisable to create a separate document (preclinical assessment), as this is already half the battle to the final initial clinical assessment.

And here the digitalization of clinical trials plays a role again:

With the close integration of the clinical trial not only with the process of literature search and thus with the clinical assessment as reported in the last blog post, but also with the technical documentation, digitalization of the essential documents of the clinical trial such as: b.

Clinical trial plan (Appendix XV, Chapter II, Section 3 of the MDR)
Clinical Investigator's Manual (Appendix XV, Chapter II, Section 2 of the MDR)
preclinical assessment

possible.

The advantages of digitalization are obvious:

more efficient work
Target-oriented use of capacities
Elimination of inefficiencies in the creation, maintenance and modification of technical documentation content, clinical evaluation and literature searches
long-term reduction in care costs

Using the “Polarion” application, interfaces such as purpose, risk management, usability, clinical evaluation, clinical trial can be assigned to projects and reused if necessary. The creation and maintenance of documents is thus significantly simplified and accelerated. In addition, redundancies and inconsistencies are avoided.

3. Outlook

Our “Adventspecial” next week will focus on the interfaces to technical documentation in PMCF studies.

4. How we can help you

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation

At medXteam, clinical data is our core focus. We collect this data through literature searches or directly with the medical device during clinical trials. This article demonstrates how literature searches serve as an interface and how data can be collected digitally.

Abbreviations

CEP Clinical Evaluation Plan

CER Clinical Evaluation Report

CIP Clinical investigation plan

DiGA digital health application

MDR Medical Device Regulation; EU Regulation 2017/745

PMCF Post-market clinical follow-up

SotA State of the Art

Underlying regulations

EU Regulation 2017/745 (MDR)
Medical Devices Implementation Act (MPDG)

1 Introduction

Clinical data is indispensable for every medical device manufacturer and for every medical device:

“Clinical data” means safety or performance information obtained through the use of a product from the following sources:

clinical trial(s) of the product in question,
clinical trial(s) or other studies reported in the scientific literature on a product whose similarity to the product in question can be demonstrated,
in peer-reviewed scientific literature published reports of other clinical experience either with the device in question or with a device whose similarity to the device in question can be demonstrated,
Clinically relevant data from post-market surveillance, in particular from post-market clinical follow-up.

(SOURCE: MDR, Article 2)

How clinical data will be collected should be defined at the very beginning of every product development process. On behalf of manufacturers, we collect this data as needed through clinical trials or literature reviews, which in turn also serve as the basis for clinical trial designs, evaluation concepts for digital health applications (DiGA) studies, and descriptions of the state of the art (SotA).

The collected clinical data are summarized in the clinical evaluation or as part of its update. Clinical evaluation is therefore central to every data collection process; or, put another way, every piece of data collected contributes to the clinical evaluation, which then analyzes and assesses this data.

This article presents our solution for collecting clinical data digitally and automatically for clinical evaluation or as input for a clinical trial.

2. Types of clinical trials

For medical devices, a distinction is made between four different types of clinical trials:

Fig. 1 Clinical trial types

This article focuses in particular on clinical trials to demonstrate the conformity of products (Articles 62 ff of the MDR, also called "approval study"), clinical trials relating to products bearing the CE marking (Article 74 of the MDR or exception thereto, also called "PMCF study") and DiGA studies.

Other clinical investigations (Article 82 of the MDR) primarily serve to advance scientific knowledge and take place outside the conformity assessment procedure and outside of post-market clinical follow-up (PMCF). Therefore, they are not included in the clinical evaluation. Nevertheless, a literature search must also be conducted for the protocols of these other studies.

2.1 Clinical trial to demonstrate product conformity

Such a clinical trial is also called a registration study. In this case, clinical data are collected directly for the medical device as part of a clinical trial. These data, along with state-of-the-art data, are then incorporated into the initial clinical evaluation of the medical device.

Such a clinical trial must include, among other things, a preclinical evaluation. This includes:

preclinical/verification data for the product
State of the art data

To obtain data on the state of the art, a literature search is required.

This preclinical assessment also serves as the basis for the clinical investigation plan (CIP), as this provides a

"Description of the relevance of the clinical trial in the context of the state of the art in clinical practice"

must contain (Annex XV, Chapter II, paragraph 3.4 of the MDR).

The clinical data summarized in the clinical investigation report (Annex XV, Chapter II, paragraph 3.17 of the MDR) as part of this clinical investigation are incorporated into the clinical evaluation, which also includes a chapter on the state of the art, which can be updated from the preclinical evaluation.

The literature search here focuses on clinical data on the state of the art, alternative procedures and their outcomes.

2.2 PMCF Study

For clinical trials relating to products bearing the CE marking (Article 74 of the MDR) and exempt PMCF studies, a study plan must also be drawn up, which – unlike for registration studies – is based on the most recently completed clinical evaluation, its possible data gaps and remaining questions.

A literature search was also conducted as part of the clinical evaluation in this regard.

2.3 DiGA studies

DiGA studies serve to demonstrate the positive healthcare effect of digital health applications (DiGA).

For this purpose, an evaluation concept prepared according to generally accepted scientific standards must be submitted in advance of the fast-track procedure, which adequately takes into account the results of the systematic data analysis.

"The systematic data analysis includes not only a systematic literature search and evaluation but also the inclusion of our own systematically evaluated data obtained in the application of DiGA."

Therefore, a systematic literature search must also be carried out in the context of a planned DiGA study, which will then also be included in the CIP of the DiGA study.

This literature may, to some extent, originate from clinical evaluations. However, since the endpoints of the DiGA study can cover not only the claims of the clinical evaluation regarding clinical performance, safety, and clinical benefit (via the demonstration of the medical benefit of the DiGA), but also endpoints relating to patient-relevant structural and procedural improvements, a separate literature search is recommended.

3. Digitized literature search

The previous section shows:

Fig. 2 Literature search in the center

Literature searches can sometimes be very time-consuming and lengthy. Therefore, as part of the digitization of technical documentation, clinical evaluation, and in particular literature searches, were also digitized and the process automated.

3.1 Digitized literature search via Polarion

Literature search is the core process of clinical evaluation.

When searching for literature via Polarion, a direct connection is established to the database sources (e.g. directly to PubMed).

The literature search is carried out and documented in the form of the following documents:

Literature Search and Review Plan

The literature search and review plan describes the objective search and describes the identification of publications. It includes:

Sources of publications
Search terms
defined filters
Assessment criteria and process for identified publications
Process for analyzing the relevant publications
Literature Search Execution Protocol

The implementation protocol provides details of the research carried out and an overview of the history of the research. It includes:

Search queries and results used
Deviations from the literature search and review plan
Overview of searches carried out and search results
Literature Review Report

The report contains a summary of the search carried out, as well as the evaluation and analysis. It includes:

Summary of objective search execution and results
conducted search and selection procedures for identification by other means
Evaluation of the identified publications
Analysis of the relevant publications (see following section)

Documentation of the analysis

Conducting objective searches in PubMed and PubMed Central can be partially automated using digital software solutions to ensure traceable and reproducible search documentation and to reduce the effort required to document search results. The solution used (Polarion with the avaPubMed extension) offers a direct, validated interface to PubMed and PubMed Central.

The full text of each potentially relevant publication is read and analyzed with regard to the scope of the literature search and the relevant clinical assessment topics in the respective clinical assessment plan. The extracted statements about safety, performance, benefits, demands or state of the art are documented.

The analysis of a single "publication" is documented in the form of a single "publication evaluation" (see diagram below): The "publication" is linked to the "publication evaluation" and the evaluation is linked to the respective "clinical evaluation object" linked in the clinical evaluation plan. The following graphic explains the connection between the individual work item types:

Fig. 3: Analysis

Literature review report

The literature search report provides an overview and summary of the analysis:

For each clinical assessment topic, it is listed which publication was identified as being relevant to this topic and which specific statements were extracted in the publication assessment.

Based on these results, it is analyzed whether the relevant data sets as a whole show evidence for the respective clinical evaluation subject (the respective claim, see figure above). The aim is to look for consistency of results across specific clinical assessment topics. If different results are observed across datasets, it is helpful to determine the reason for these differences.

The following graphic visualizes the connection between the documents and the digital content they contain in the form of work items:

Fig. 4 Interfaces and work items

3.2 Digitized clinical evaluation

Clinical evaluation is an essential part of the technical documentation (initially as part of the conformity assessment procedure and updates as part of clinical follow-up).

Its core feature is the literature search, which can be performed digitally (like this). Embedded within Polarion as a subsystem, it can also be digitized itself. The following figure provides an overview of the content of the documents for clinical evaluation

CEP,
CERIUM,
Literature search documents – plan, minutes, report

embedded as a subsystem in the overall technical documentation system:

Fig. 5 Overall system Technical documentation

3.3 Digitized clinical trial

And with the close integration of clinical trials (whether for approval, within the framework of clinical evaluation or within the framework of a DiGA study) with the literature search process and thus with the clinical evaluation, digitization of the essential documents of the clinical trial, such as...

Clinical trial plan (Appendix XV, Chapter II, Section 3 of the MDR)
Clinical Investigator's Manual (Appendix XV, Chapter II, Section 2 of the MDR)
preclinical assessment

possible.

3.4 Advantages of Digitalization

The digitalization of technical documentation for medical devices and thus clinical evaluation and literature search is the future!

The advantages of digitalization are obvious:

more efficient work
Target-oriented use of capacities
Elimination of inefficiencies in the creation, maintenance and modification of technical documentation content, clinical evaluation and literature searches
long-term reduction in care costs

Via Polarion, interfaces such as purpose, risk management, usability, clinical evaluation, clinical trial can be assigned to projects and reused if necessary. The creation and maintenance of documents is thus significantly simplified and accelerated. In addition, redundancies and inconsistencies are avoided.

4. What we can do for you

If a clinical trial is to be carried out, basic safety and performance requirements must first be met, and therefore essential technical documentation must be prepared.

The clinical trial culminates in the clinical evaluation, which then forms the basis for PMCF activities (including a PMCF study).

Therefore, we support you throughout your entire project with your medical device, always with primary reference to the clinical data on the product: from the beginning to the end.

Please note the following two events:

October 6, 2021, 4:00 PM – 8:00 PM Start-up Night of the Healthcare Industry

Q&A session on Regulatory & Clinical Affairs – Innovation and technology meet regulation, approval and market surveillance (Hans Wenner, VDE and Daniela Penn, medXteam)

November 11, 2021, 2:00 PM – 3:00 PM: Second free medXevent:

Digitalized clinical assessment from the perspective of clinical trials

5. How we can help you

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation

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3.1 Advantages and necessity of digitizing quality management

3.2 orgavision and the digitalization of quality management

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