The undetected trap? The black box of the new DiGA requirements

At medXteam, the focus is on clinical data. In this context, as CRO we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. This time the topic in this context is the DiGA. Data is also collected here. But this time the focus is on the question: Why are doctors holding back on prescribing DiGAs? In the following blog post, Dr. med. Gisela Knopf contributed. As a general practitioner, she has already had extensive experience in this area.

Since October 2023, the previous month's blog post has also been published as a podcast ( medXteam Kompakt ). This article appears as an interview with Dr. med. Gisela Knopf will then be available as a podcast in December 2023.

Abbreviations

DiGA Digital Health Application

KV Association of Statutory Health Insurance Physicians

Underlying regulations

Digital Healthcare Act (DVG)
Digital Health Applications Ordinance (DiGAV)
DiGA Guide

1 Introduction

DiGAs (Digital Health Applications) have become increasingly important as digital applications in healthcare in recent years. They can help improve medical care and facilitate access to healthcare services. They provide patients with the ability to monitor their health and manage disease while providing doctors with valuable data to make better decisions.

Despite this, many physicians appear hesitant to prescribe DiGAs. This article examines this situation and the perspectives of doctors and health insurance companies. It also examines the reasons for this reluctance and suggests ways in which physicians can be encouraged to prescribe DiGAs.

2. Introduction to the DiGAs

DiGAs are medical applications that are reimbursed by health insurance companies and can be prescribed by doctors at the expense of the health insurance companies. They are intended to improve medical care, for example by helping to diagnose diseases or support the monitoring of patients. DiGAs can be used, for example, in the treatment of diabetes, mental illnesses or for smoking cessation. The applications are usually easy to use and can be downloaded to smartphones or tablets.

3. Case studies of successful implementation of DiGAs

DiGAs have become more important in recent years. They include a variety of applications, from fitness trackers to specialized health apps. Many of these applications were developed by medical professionals and provide evidence-based solutions to improve health. Nevertheless, DiGAs are often not formulated or used.

One reason for this problem is the lack of awareness and training among doctors. Many doctors are either not aware that DiGAs are approved as medical aids or they do not have sufficient knowledge of the benefits and possible uses. This means that they do not prescribe DiGAs or are hesitant to recommend them.

There are already some successful examples of the implementation of DiGAs in medical care. One example is the formulation of DiGAs for the treatment of diabetes. Applications can be used here to monitor blood sugar levels and support self-management of the disease. Another example is the use of DiGAs to treat anxiety disorders and depression. Appropriate applications can be used here to support psychotherapeutic treatment.

4. Prescription of DiGAs

Physicians have various concerns and challenges when it comes to prescribing DiGAs. On the one hand, they are concerned about the quality and effectiveness of the applications. You want to be sure that the DiGAs are evidence-based and actually help patients. On the other hand, doctors have limited time during patient consultations and do not want to have to recommend or prescribe too many different applications.

To address these challenges, better training and education for physicians is needed. They need to be informed about the latest developments in the field of DiGAs and learn how to effectively integrate them into their practice. In addition, criteria and guidelines should be developed to ensure the quality and effectiveness of DiGAs or, ideally, the DIGAs should be integrated into the existing guidelines.

4.1 The role of the doctor in prescribing DiGAs

Prescribing DiGAs is the responsibility of physicians. They must decide which applications are best for their patients, what benefits they can provide, and whether they are cost-effective. Doctors must also ensure that the applications are safe and effective and that they are funded by health insurance companies. This requires a certain level of expertise and experience in relation to DiGAs.

Doctors and psychotherapists can issue a prescription (sample 16) for a DiGA if the prescription is medically necessary. Economic efficiency must always be taken into account.

The cost-effectiveness principle also applies to apps: The DiGA regulation also applies to the cost-effectiveness requirement, according to which the service must be sufficient, appropriate and economical (Section 12 SGB V).

(Source: Apps on Recipe , accessed on November 3rd, 2023)

4.2. Factors contributing to physicians' reluctance to prescribe DiGAs

Despite the benefits of DiGAs, many doctors are hesitant to prescribe them. One reason for this is that they are not sure whether DiGAs are actually effective. There are also concerns about the security of DiGAs and data security. Another factor is the lack of time and resources to support patients in the use of DiGAs. Additionally, many physicians are concerned about the additional burden of prescribing and monitoring DiGAs. And last but not least, there is the concern as to whether the health insurance companies will really cover the costs or whether a corresponding prescription can lead to recourse.

Added to this is the already very complicated billing and prescription system used by statutory health insurance physicians. Especially with the constantly hovering sword of Damocles of the risk of recourse (see also the following section). Recourse means that a doctor who makes a “mistake” (according to the KV specifications) in prescribing a health insurance service can and often actually is asked to pay for this service. In the case of DIGAs, this means becoming the prescribing doctor The costs of € 300 - 500 may be billed personally. And in order to correctly carry out a DIGA prescription, a few points are required that are set by the Association of Statutory Health Insurance Physicians, which also differ from DIGA to DIGA if, for example, this is changed from “provisional” to “permanent” or from “provisional” to “no longer available on the list”. And how should the KV requirement of “economic efficiency” be met? Perhaps the DIGA will ultimately be compared with a medication that costs a few cents per day for therapy? What the KV understands by economic efficiency is unfortunately usually not defined in detail for the individual case and is the big black box when it comes to the risk of recourse. Unfortunately, it is well known that apples are often compared with oranges without the medical profession having any influence.

4.3 Impact of budget constraints on the prescription of DiGAs

Another important factor that can contribute to doctors' reluctance to prescribe DiGAs is the very special and sometimes difficult to understand billing systems of statutory health insurance physicians, including budget restrictions. The health insurance companies provide limited resources for financing DiGAs and so there are major concerns among the medical profession as to whether and under what conditions DIGAs will be reimbursed by statutory (and private) health insurance companies. Doctors are under constant pressure to work cost-effectively, combined with the ever-present time pressure in practice. Just dealing with the matter of when which DIGA can be prescribed and under what conditions requires a lot of time.

In addition, there is the Sword of Damocles already mentioned above, that if one of the specified conditions was (inadvertently) not met, the health insurance company or the Association of Statutory Health Insurance Physicians will generally refuse to cover the costs and the doctor will be billed for the costs of the DIGA in the form of recourse be provided. This risk is avoided if the doctor does not prescribe DIGA at all or recommends that the patient get a corresponding app themselves.

4.4 Addressing physician concerns regarding DiGAs

To encourage physicians to prescribe DiGAs, their concerns and concerns must be addressed. One way to do this is to provide training and education to improve physicians' knowledge and understanding of DiGAs. It may also be helpful to emphasize the benefits of DiGAs, such as improving patient care and reducing costs. Another option is to give doctors the opportunity to try DiGAs and test them themselves to assess their effectiveness and safety.

5. Health insurance companies’ perspective

Health insurance companies also play an important role in the prescription of DiGAs. They must ensure that the applications they reimburse actually provide patient benefit and are cost-effective. For this reason, they often conduct their own assessments and studies to verify the effectiveness of DiGAs.

Another problem that health insurance companies have is the large number of DiGAs available. They have to decide which applications they will reimburse and which they will not. This requires careful evaluation and selection to offer patients the best options.

6. Overcoming barriers to prescribing DiGAs

To promote the prescription of DiGAs, barriers to the adoption and use of DiGAs must be overcome. This includes providing sufficient resources and training for doctors and patients. With regard to doctors, the prescription modalities in particular must be trained or, better yet, significantly simplified, which then also fits with the topic of digitalization.

It may also be helpful to encourage collaboration between physicians and developers of DiGAs to ensure that the applications meet patients' needs. In addition, health insurance companies for DiGAs can create meaningful incentives for the prescription of DiGAs in order to promote acceptance and use. The health insurance companies already have these incentives, but obtaining them is so complicated and confusing that the ratio of profit to effort is not worth it for most doctors.

6.1 The future of DiGAs in healthcare

The future of DiGAs in healthcare is promising. They can help improve medical care and facilitate access to healthcare services. DiGAs can also help reduce healthcare costs by reducing the need for expensive follow-up medical costs. The demand for DiGAs is expected to continue to increase in the coming years as more and more people have access to digital technologies.

6.2 Resources for physicians to learn more about DiGAs

A number of resources are available for physicians interested in learning more about DiGAs. This includes training and education, specialist magazines and online resources. It can also be helpful to exchange ideas with colleagues who already have experience with the regulation of DiGAs. Although all of this is available, the effort required to obtain information must remain manageable; the prescription of DIGAs is ultimately only a very small part of the medical field of application.

7. Conclusion

DiGAs have the potential to improve medical care and make it easier for patients to access digital health applications.

There are a number of reasons for physician reluctance to prescribe, with concerns about the effectiveness and safety of DiGAs likely outweighed by the risk of recourse and lack of time.

In this respect, doctors simply hesitate to prescribe a form of therapy in the three-digit price range for the reasons mentioned above, which the manufacturers are probably not aware of. The fact that patients can sometimes receive the DIGAs directly from the health insurance company without a doctor's prescription seems to be a good approach here.

To promote the prescription of DiGAs, barriers must be overcome and physicians must be encouraged to become familiar with DiGAs. For example, better training and education for doctors as well as clear and, above all, uniform criteria and guidelines for DiGAs are required. In addition, health insurance companies may need to improve their evaluation processes to select the best DiGAs.

5. 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.

If a clinical trial is to be carried out, basic safety and performance requirements must first be met. The data from the clinical trial then feed into the clinical evaluation, which in turn forms the basis for post-market clinical follow-up (PMCF) activities (including a PMCF study).

In addition, all medical device manufacturers require a quality management system (QMS), including when developing Class I products.

We support you throughout your entire project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation through to technical documentation - always with primary reference to the clinical data on the product: from the beginning to the end End.

Do you already have some initial questions?

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

At medXteam, the focus is on clinical data. In this context, as CRO we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. No matter which form of data collection you choose, it is important to have solid planning but also to deal with the various options and the respective requirements. In clinical trials with medical devices, the sponsor plays a particularly important role: he is responsible for the proper planning and execution of the clinical trial.

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

MPDG Medical Devices Implementation Act

MPAnpG Medical Devices Adaptation Act

Underlying regulations

EU Regulation 2017/745 (MDR)
Medical Device Implementation Act (MPDG)
ISO 14155

1 Introduction

Clinical trials are an essential part of medical device law to ensure the safety and performance of medical devices. ISO 14155 specifies the requirements for conducting these clinical trials. In this article we want to first take a closer look at the role of the auditor and then at the important role of the sponsor and identify their respective tasks and responsibilities.

This article will bring to light what effects the responsible role of the sponsor has and what needs to be taken into account here - ideally before it starts at the test center.

2. Role of the auditor

2.1 Definition and appointment

An investigator works in a testing center as part of the clinical trial. The principal investigator appoints this person, although the appointment should be made in coordination with the sponsor. This is crucial because the sponsor must inform the ethics committee about the examiners and their qualifications when applying for the ethical review.

2.2 Tasks of the examiner

The role of the investigator in clinical trials according to ISO 14155 is of central importance and is clearly defined by the standard and the Medical Devices Law (MPDG). Both direct and indirect requirements are placed on the investigator to ensure the quality, integrity and safety of the clinical trials. Some of the specific duties and responsibilities of the auditor are:

1. Perform trial-related clinical procedures and make key trial-related clinical and medical treatment decisions.
2. Ensuring that the clinical trial is carried out in accordance with the trial plan (according to Section 62 Paragraph 1 No. 1 MPDG).
3. If the examiner is a doctor or dentist, he must carry out the information and obtain the consent of the test participant (according to Section 28 Para. 2 MPDG).
4. Participate in investigator meetings organized by the sponsor.
5. Ensuring the accuracy, attribution, completeness, readability and timeliness of the source data as well as the data submitted to the sponsor in the CRFs (Case Report Forms) and all required reports.
6. For subjects who discontinue study participation, request permission to collect follow-up data about their condition or illness.
7. Assessment of adverse events (AEs), particularly in terms of severity and relationship to the investigational product.
8. In the event of circumstances that may affect the safety of test participants, users or third parties, all necessary safety measures must be taken immediately to avert direct or indirect danger (according to Section 66 Para. 1 MPDG).
9. If there is only one examiner in the testing center, he or she automatically takes over the tasks of the main examiner.

The investigator's responsibilities are extensive and varied, with each step contributing to ensuring the safety of patients and the integrity of the clinical trial. It is therefore essential that auditors are comprehensively trained and know and understand all relevant regulations and requirements.

2.3 Independence of the auditor

It is crucial that the auditor is independent. It must neither be influenced by the sponsor nor influence other people or institutions involved in the examination.

2.4 Communication with Sponsor

The investigator should receive all necessary information from the sponsor to ensure consistent assessment and documentation of the findings obtained during the trial.

3. Role of the sponsor

3.1 Definition and responsibility

The sponsor is responsible for initiating, managing and financing the clinical trial. He must be based in the European Union or appoint a legal representative based in the EU. This representative assumes responsibility for compliance with the sponsor's obligations and is the contact person for the authorities and the ethics committee.

3.2 Responsibilities of the Sponsor

ISO 14155 defines a variety of tasks for the sponsor, including:

• Planning and preparation of the clinical trial: This includes, among other things, determining the needs for the clinical trial, risk management, concept development and selection of clinical staff.
• Conducting the clinical trial: This includes ensuring compliance with the trial plan, monitoring, data quality and the protection of personal data.
• Safety assessment: The sponsor must record, assess and document all adverse events.
• Termination of the clinical trial: This also includes communication with the authorities and, if necessary, interrupting or terminating the trial.

The second point, the conduct of the clinical trial, plays a particularly crucial role here. To ensure this, the following measures should be taken into account:

In advance, before the start at the test center:

1. Selecting the right trial center: The trial center should have the necessary facilities and resources and, ideally, already have experience with clinical trials.
2. Training of the test center: The center should be informed about the current requirements and specifications as well as legal principles and should have received regular training in this regard.
3. Verification of qualifications: Ensure that the investigator, or at least the principal investigator in a multi-assessor center, has current GCP-MDR training.
4. Qualifications of the study team: The team carrying out the study, especially the study assistants (study nurses), should be properly qualified and trained. Regular training can help to keep knowledge up to date.
5. Preliminary Audits: Independent audits may be conducted prior to the start of the study to verify compliance with GCP guidelines.
6. Clear communication channels: Clear communication and reporting procedures should be established before the start of the study.

During the study:

1. Regular monitoring: During the conduct of the study, the study site should be monitored regularly to ensure that the study protocols are properly followed. This is done via monitoring, which is also stipulated in ISO 14155.
2. Internal Audits: The trial site may conduct internal audits to ensure compliance with study policies and procedures itself. But the sponsor can also carry out an on-site audit to ensure correct implementation.
3. Documentation requirements: All relevant documents should be recorded and archived correctly and promptly.
4. Ongoing training: If there are changes in regulations or study protocol, the entire study team should be retrained.

According to the study:

1. Close-out visit: After completion of the study, the final monitoring appointment is carried out in accordance with ISO 14155 to check compliance with all requirements and correct implementation on site.
2. Feedback loop: Errors or problems that occurred during the study should be analyzed and integrated into future training and processes.

Following these steps can ensure the proper conduct of clinical trials at a trial site.

Figure: Interaction sponsor - examiner

4. Conclusion

In summary, both the investigator and the sponsor play central roles in ISO 14155 clinical trials. Their respective roles and responsibilities are clearly defined to ensure the integrity and quality of clinical trials. It is of immense importance that both parties carry out their roles correctly and diligently to ensure the safety and effectiveness of medical devices for patients. Particularly in advance of a study, targeted preparation and planning can contribute a lot to its successful implementation. This includes, among other things, comprehensive training of the trial center to ensure that not only the investigator but the entire study team are trained in accordance with GCP-MDR. The early identification and qualification of study nurses and other key personnel in the study site can also make a decisive contribution to minimizing possible obstacles or delays during the study. In addition, a clear communication strategy between the sponsor and the test center should be established in advance in order to avoid misunderstandings and potential sources of error right from the start. Given the high demands and enormous responsibility that clinical trials entail, proactive, well-thought-out preparation is essential for success. It is the joint responsibility of the sponsor and auditor to ensure that all requirements and standards are not only met, but consistently implemented.

5. 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.

If a clinical trial is to be carried out, basic safety and performance requirements must first be met. The data from the clinical trial then feed into the clinical evaluation, which in turn forms the basis for post-market clinical follow-up (PMCF) activities (including a PMCF study).

In addition, all medical device manufacturers require a quality management system (QMS), including when developing Class I products.

We support you throughout your entire project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation through to technical documentation - always with primary reference to the clinical data on the product: from the beginning to the end End.

Do you already have some initial questions?

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

At medXteam, the focus is on clinical data. In this context, as CRO we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. No matter which form of data collection you choose: The foundation is solid planning but also dealing with the various options and the respective requirements. A good example of the fact that with the MDR requirements are not only becoming more stringent and increasing is what is presented in this blog post: namely the changed qualification requirements for study staff and the consequences that result from this, which in certain cases even lead to one lead to relief.

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

MPDG Medical Devices Implementation Act

MPAnpG Medical Devices Adaptation Act

MPG Medical Devices Act

LKP Head of Clinical Trials

Underlying regulations

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

1 Introduction

The rapid development in the medical technology industry entails constant adaptation and further development of the legal framework. In particular, the introduction of EU Regulation 2017/745, better known as the Medical Device Regulation (MDR), and the national legislation derived from it in Germany through the Medical Device Adaptation Act (MPAnpG) and the Medical Device Implementation Act (MPDG) have profound effects on planning and Conducting clinical trials.

The consideration of whether to opt for a monocentric or a multicentric design for clinical trials in accordance with Articles 62, 74 or 82 of the MDR plays a central role. Although the MDR and the MPDG entail stricter regulation in many areas, there are also significant simplifications in certain aspects. Such facilitation particularly affects the design of clinical trials. For example, the approval hurdles are significantly lower for monocentric studies. But what exactly are the advantages they offer, and what challenges and requirements do they pose, particularly in terms of the qualifications of the required study staff?

This blog post sheds light on the critical differences and associated regulatory and organizational considerations in the context of clinical trial design. Particular attention will also be paid to the role and requirements of study staff, which are clearly defined and brought into focus by the new legislation.

2. Single-center study vs. multicenter study

The design of a clinical trial depends on various factors, including the type of medical device, the objective of the study and the available resources. Depending on which design is chosen, there are different requirements for the study staff and the organization of the study.

The choice of clinical trial design, whether monocenter or multicenter, has profound implications for implementation, budget, scheduling, and data quality. 

2.1 Monocentric study

A single-center study is a clinical trial conducted at a single center or location. The study team usually consists of an investigator. However, for larger studies at one location or when different departments are involved, the team can also consist of several investigators. In this case, one of the investigators will be appointed as the principal investigator, who will be responsible for the overall coordination of the study. In addition, other participants such as study nurses, who are responsible for patient care and data collection, may be part of the study team.

Advantages of single-center studies:

• Simplicity: Since only one location is involved, the processes are typically less complex.
• Cost: Because fewer staff and resources are required, costs are typically lower.
• Control: The investigator or principal investigator has direct oversight and control over all aspects of the study.
• Faster communication: With a smaller team and only one location, agreements and decision-making processes are usually faster and more direct.

However, this simplicity and cost savings may be offset by the limited patient pool and geographic limitation. There is a risk that the results will not be universal or that it will be difficult to recruit enough patients for the study. If many patients are required according to statistical sample size planning, this form of design cannot be chosen as it cannot then be implemented in a reasonable time frame.

2.2 Multicenter study

Multicenter studies are clinical trials that are conducted at multiple locations or centers. In such studies, the study team in each center typically consists of an investigator, a study nurse and, if necessary, other professionals involved. Despite the multiple center structure, the process in each center remains similar to that of monocentric studies. The difference is that such a study design requires a principal investigator site. This main investigation center provides the head of the clinical trial (LKP), who coordinates the entire study across all centers.

Advantages of multicenter studies:

• Patient pool: The participation of several centers enables access to a larger and heterogeneous patient population.
• Data base: The design allows for broader and more representative data collection as it comes from different populations and locations. The scientific validity also increases due to the involvement of several examiners and the external validity increases.
• Comparability: Direct comparisons and consistency checks can be carried out through different locations.

However, these advantages may be offset by increased costs, greater organizational effort and coordination requirements between centers.

• Core factors: costs, effort and study staff:
• Cost: Multicenter studies can be more expensive than single-center studies due to their size and complexity.
• Effort: The organizational effort for multicenter studies is significantly higher, especially with regard to the coordination of patient recruitment, data management and communication between the centers.

Study staff: This is one of the most critical aspects. The challenge is to ensure consistent protocols and practices across all centers. This particular sticking point and the associated considerations and strategies are discussed in detail below.

3. Development of qualification requirements for examiners: From MPG to MPAnpG

As the regulatory landscape for medical devices in Germany has evolved, the qualification requirements for people involved in conducting clinical trials have also changed.

3.1 Under the Medical Devices Act (MPG)

According to Section 20 of the Medical Devices Act (MPG), clinical trials had to meet certain requirements. A crucial aspect was that they had to be carried out in an appropriate facility and led by an "appropriately qualified examiner". The MPG gave clear requirements for the qualifications of this examiner: In addition to medical or dental training, he had to be able to demonstrate at least two years of experience in the clinical testing of medical devices.

This requirement applied to all auditors, regardless of whether they were auditors, main auditors or LKP.

3.2 Transition to the Medical Devices Adaptation Act (MPAnpG or MDPG)

With the introduction of the Medical Devices Adaptation Act, the requirements for the qualifications of study staff were specified and expanded.

Since there was no role definition in the MPG and this had to be taken from ISO 14155 before the MPDG came into force, the MPDG now defines at least the roles of main auditor and LKP in § 3 (5,6):

"According to Section 30 of the MDPG, there are clear distinctions between the investigator, the main investigator and the head of a clinical trial. While the principal investigator and investigator continue to play important roles in the clinical trial, the specific qualification of at least two years of experience in the clinical trial of medical devices is now explicitly assigned to the head of a clinical trial or other clinical trial. "

This means that, compared to the previous MPG, the qualification requirements have become more specific and are more specifically tailored to the different roles in the clinical trial process. This shows an increased awareness of the need for clearly defined and strict qualification criteria to ensure the quality and integrity of clinical trials. It also reflects the growing complexity and importance of clinical trials in the process of medical device development and approval.

3.3 Consequences and effects

The ongoing adaptation and refinement of the legal framework has a significant impact on how clinical trials of medical devices are carried out. In particular, the Medical Devices Implementation Act (MPDG) has brought about some fundamental changes that influence the organization and approval of clinical trials.

One such significant change made in the MPDG thus concerns the roles and qualifications of those involved in clinical trials. According to Section 30 of the MDPG, a distinction is now made between the investigator, the main investigator and the head of a clinical trial. It is crucial to recognize that the minimum two years of experience in the clinical testing of medical devices for any investigator, previously required in the MPG, is now only explicitly assigned to the head of a clinical trial or other clinical trial, even in a single-center study. This requirement therefore only applies to multicenter studies.

While auditors and principal auditors continue to play important roles in the process, the specific qualification requirement now applies only to the audit manager.

For single-center studies, this means that the approval process for a clinical trial is significantly simplified. By focusing the two-year experience requirement on the head of a clinical trial and not on each investigator involved, the hurdle for conducting such studies is significantly reduced, as the ethics committee no longer expects this requirement for the investigator and therefore no longer examines it.

4. Conclusion

The conclusion from these observations is evident: the choice between monocenter and multicenter design has a significant impact on the approval, costs, organizational effort and requirements for study staff of a clinical trial. Correct planning and consideration of all relevant aspects are therefore essential for the success of the project. It is crucial to think intensively about the requirements and select the appropriate personnel for the respective type of study.  

The choice between monocenter and multicenter design has significant implications for the approval, cost, effort, and study staff requirements of a clinical trial. Correct planning and consideration of all relevant aspects are therefore essential for the success of the project. It is crucial to think intensively about the requirements and select the appropriate personnel for the respective type of study.

This aspect in particular has a significant influence on the conduct of clinical trials. The Medical Devices Implementation Act (MPDG) has introduced significant changes, particularly with regard to the roles and qualifications of those involved in a clinical trial.

Section 30 of the MDPG and the associated clear distinction between the investigator, the main investigator and the head of a clinical trial have significantly simplified the approval process for monocentric studies. The specification that at least two years of experience in the clinical testing of medical devices is now explicitly attributed to the head of a clinical trial opens up new possibilities in the design of clinical trials and lowers the hurdles to their implementation.

A deeper understanding of the legal requirements and careful selection of the appropriate personnel for the specific type of study are essential key aspects. It is of central importance to deal intensively with these requirements and to plan accordingly.

However, this only applies to clinical trials carried out within the framework of the MDR (Articles 62, 74 and 82). All other clinical trials (e.g. PMCF studies within the intended purpose of the medical device and without stressful examinations remain unaffected. This means that there are no requirements of this type for the LKP in multicenter studies.

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 essential technical documentation must therefore be created.

In addition, all medical device manufacturers require a QMS, including when developing Class I products.

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

We therefore support you throughout your entire project with your medical device with primary reference to the clinical data on the product: from start to finish.

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 

At medXteam, the focus is on clinical data. We collect this through systematic literature searches or directly with the medical device as part of clinical trials. We already explained in an article last year how the literature search represents an interface and how the data can be collected digitally. We also act as quality management representatives for our customers and build quality management systems in this context. These can also be digitized, which means that our offering takes us one step further when it comes to 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 significant digital transformation in recent years. Technologies such as artificial intelligence and the Internet of Things have become driving forces that are revolutionizing the way we develop and use medical devices. This digital revolution also has an impact on the area of ​​quality management, especially in the context of medical devices.

Every manufacturer of medical devices is legally obliged to implement, live and continuously maintain 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 to ensure both the safety and effectiveness of the products as well as compliance and adequate implementation of regulatory requirements and legal requirements.

In this digital era, designing a digital technology environment from our quality management system provides the opportunity to drive innovation, efficiency and sustainable improvements to workflows, including optimized efficiency, increased product quality and robust documentation and tracking 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 assessment but also for clinical trials in accordance with Articles 62, 74 or 82 of the MDR.

Digital literature search enables thorough and efficient collection of relevant clinical data necessary to assess the safety and performance of a medical device.

Fig. 1 Literature search in the center

The literature search can sometimes be very time-consuming and tedious. As part of the digitization of the technical documentation, the clinical assessment and therefore in particular the literature search were digitized and the process was automated.

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

Digitalization of clinical trials improves data collection, analysis and reporting, ultimately leading to more reliable results and more efficient processes. Through our EDC system from MaganaMed, we offer exactly that by implementing electronic CRFs (eCRF).

With the close integration of the clinical trial (whether for approval, as part of the clinical evaluation, for the collection of product data after it has been placed on the market or as part of a DiGA study) with the process of literature search and thus with the clinical evaluation, digitalization is also essential Clinical trial documents 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.

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

3. Digitalization in quality management

3.1 Advantages and necessity of digitizing quality management

Digital literature searches and clinical testing are important 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 has a significant influence on quality management.

It also brings with it numerous advantages: It improves the efficiency of processes, thereby increasing the quality of medical devices and enabling better traceability and documentation. It also enables more efficient management of QMS. This is crucial to comply with ISO 13485 and MDR requirements.

A digitized QMS enables seamless and centralized document management, more efficient and transparent auditing, and improved risk and process management. All of these aspects are of crucial importance in order to ensure not only the requirements but also the high quality of the medical products.

3.2 orgavision and the digitalization of quality management

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

An example of a tool for digitizing quality management is orgavision . This tool offers a wide range of features that contribute to the digitalization of quality management systems.

With orgavision, companies can 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 digitalization of quality management systems. The functions of orgavision range from integrated digital document management to a comprehensive event management system (e.g. customer feedback, complaints, corrective and preventive measures).

Orgavision's automation function is particularly noteworthy. An example of this is the automatic update of process names. If the name of a process is changed in orgavision, this name is automatically updated when explicitly linked in all documents in which the process is mentioned. This avoids inconsistencies and misinformation and improves the accuracy and reliability of 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 groundbreaking software solution that was developed specifically for the digitization and automation of the quality management system (QMS) in the medical sector. It offers a variety of functions that support the entire QMS process and help increase efficiency. Additional features of orgavision are highlighted below:

Change management: orgavision enables efficient change management by offering a structured process for processing change requests, approvals and implementations. By digitizing this process, changes are quickly captured, tracked and documented, improving control and efficiency.

Complaint management: The tool offers functions for effectively handling customer complaints. This includes collecting, categorizing and handling 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: With the help of orgavision, training processes can be efficiently digitized and thus optimized. The training matrix provides a comprehensive overview of the training requirements and the current training status of all employees. You can include individual training elements, such as: B. Set training events, courses or webinars for different employees or employee groups.

Let us now present this example in more detail:

Fig. 2 Orgavision training matrix

Each training can be linked to corresponding competencies, departments or defined roles. This makes it possible to identify exactly which training courses are required for which employees and in which cycle. This systematic and structured approach ensures that no employee misses out on needed training and that all employees always have the necessary knowledge and skills.

orgavision also offers the option of linking and managing training certificates directly in the system. After training has been completed, relevant evidence, such as certificates or confirmations, can be uploaded directly to the system and assigned to the relevant employees.

This evidence can then be accessed at any time and can be exported from the system if necessary. Linking training records not only makes it easier to document and manage training courses, but also to check the training status of individual employees or entire teams.

4. Conclusion

The overall advantages of digitalization are obvious:

• more efficient work
• Target-oriented use of capacities
• Elimination of inefficiencies in the creation, maintenance and change of contents of technical documentation, clinical assessment and literature searches as well as in the area of ​​quality management
• Avoidance of 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 compliance.

The above-mentioned functions of orgavision enable comprehensive digitalization and automation of the QMS. This results in improved efficiency, accuracy and compliance. The central management of documents, the automation of workflows and processes as well as the digitalization of change management, complaint management and supplier management help to optimize quality management processes and meet the requirements of ISO 13485 and MDR.

In summary, it can be said that digitalization in quality management creates simplifications in the course of digitalization, solves redundancies and is therefore an absolute necessity in the long term. With the right tools and strategies, digitizing quality management can lead to more efficient processes, better 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 essential technical documentation must therefore be created.

In addition, all medical device manufacturers require a QMS, including when developing Class I products.

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

We therefore support you throughout your entire project with your medical device with primary reference to the clinical data on the product: from start to finish.

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