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 post will then be released as an interview with Dr. Gisela Knopf 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, clinical data is our core focus. As a CRO, we not only conduct clinical trials with medical devices in accordance with the MDR and ISO 14155, but also offer all other options and methods of data collection. Regardless of the chosen data collection method, sound planning is essential, as is a thorough understanding of the various options and their respective requirements. In clinical trials with medical devices, the sponsor plays a particularly crucial role: they are 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 Devices Implementation Act (MPDG)
ISO 14155

1 Introduction

Clinical trials are an essential component of medical device law, ensuring the safety and performance of medical devices. ISO 14155 specifies the requirements for conducting these clinical trials. In this article, we will first examine the role of the investigator and then focus on the crucial role of the sponsor, outlining their respective tasks and responsibilities.

This article will shed light on the impact of the sponsor's responsible role and what needs to be considered – ideally even before things get underway at the testing center.

2. Role of the examiner

2.1 Definition and Appointment

An investigator works at a study site as part of a clinical trial. The principal investigator appoints the investigator, and this appointment should be made in consultation with the sponsor. This is crucial because the sponsor must inform the ethics committee of the investigators and their qualifications when applying for 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 German Medical Devices Act (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 investigator's specific tasks and responsibilities include:

1. Conducting exam-related clinical procedures and making important exam-relevant clinical and medical treatment decisions.
2. Ensuring that the clinical trial is carried out in accordance with the study protocol (pursuant to Section 62 Paragraph 1 No. 1 MPDG).
3. If the examiner is a physician or dentist, he must provide information and obtain the consent of the examinee (in accordance with Section 28 Paragraph 2 MPDG).
4. Participation in examiner meetings organized by the sponsor.
5. Ensuring the accuracy, attribution, completeness, legibility and timeliness of the source data as well as the data transmitted to the sponsor in the CRFs (Case Report Forms) and all required reports.
6. For study participants who complete their participation, request permission to collect follow-up data on their condition or illness.
7. Evaluation of adverse events (AEs), particularly with regard to severity and relationship to the test product.
8. In the event of circumstances that could compromise the safety of test participants, users or third parties, all necessary safety measures must be taken immediately to avert any immediate or indirect danger (in accordance with Section 66 Paragraph 1 MPDG).
9. If there is only one inspector at the testing facility, this inspector automatically takes over the duties of the chief inspector.

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

2.3 Independence of the auditor

It is of central importance that the auditor is independent. They must not be influenced by the sponsor or by other persons or institutions involved in the audit.

2.4 Communication with the sponsor

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

3. Role of the sponsor

3.1 Definition and Responsibility

The sponsor is responsible for initiating, managing, and financing the clinical trial. They must be based in the European Union or appoint a legal representative based in the EU. This representative is responsible for ensuring the sponsor's compliance with their obligations and serves as the point of contact for regulatory authorities and the ethics committee.

3.2 Tasks 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 need for the clinical trial, risk management, concept development and selection of clinical staff.
• Conducting the clinical trial: This includes ensuring compliance with the study protocol, monitoring, data quality and the protection of personal data.
• Safety assessment: The sponsor must record, assess, and document all undesirable events.
• Termination of the clinical trial: This also includes communication with the authorities and, if necessary, the interruption or termination of 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 considered:

Even before the start at the testing center:

1. Selecting the right trial site: The trial site should have the necessary facilities and resources and ideally already have experience with clinical trials.
2. Training of the testing center: The center should be informed about the current requirements and specifications as well as legal foundations and should have received regular training in this regard.
3. Verification of qualifications: It should be ensured that the investigator, or at least the lead investigator in a center with multiple investigators, has current GCP-MDR training.
4. Study team qualifications: The team conducting the study, especially the study nurses, should be properly qualified and trained. Regular continuing education can help keep their knowledge up to date.
5. Preliminary audits: Independent audits can be carried out before 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 studies.

During the study:

1. Regular monitoring: During the study, the study site should be regularly monitored to ensure that the study protocols are properly followed. This is done through the monitoring process, which is also specified in ISO 14155.
2. Internal audits: The study site may conduct internal audits to ensure compliance with study guidelines and procedures. The sponsor may also conduct an on-site audit to ensure proper conduct.
3. Documentation requirements: All relevant documents should be recorded and archived correctly and promptly.
4. Ongoing training: If there are changes to the regulations or the study protocol, the entire study team should be retrained.

According to the study:

1. Close-out Visit: After completion of the study, the closing visit is carried out as part of the monitoring according to ISO 14155 to verify compliance with all requirements and the 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 center.

Image: Interaction between sponsor and examiner

4. Conclusion

In summary, both the investigator and the sponsor play central roles in clinical trials according to ISO 14155. Their respective tasks and responsibilities are clearly defined to ensure the integrity and quality of the clinical trials. It is of paramount importance that both parties perform their roles correctly and conscientiously to guarantee the safety and efficacy of medical devices for patients. Particularly in the lead-up to a study, targeted preparation and planning can significantly contribute to its successful execution. This includes, among other things, comprehensive training of the trial site to ensure that not only the investigator but the entire study team is trained in accordance with GCP-MDR. The early identification and qualification of study nurses and other key personnel at the trial site can also be crucial in minimizing potential obstacles or delays during the study. Furthermore, a clear communication strategy between the sponsor and the trial site should be established in advance to avoid misunderstandings and potential sources of error from the outset. Given the high demands and enormous responsibility that clinical trials entail, proactive and well-thought-out preparation is essential for success. It is the shared responsibility of the sponsor and the 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, clinical data is our core focus. As a CRO, we not only conduct clinical trials with medical devices in accordance with the MDR and ISO 14155, but also offer all other options and methods of data collection. Regardless of the chosen data collection method, the foundation is solid planning and a thorough understanding of the various options and their respective requirements. A good example of how the MDR not only brings more stringent and increasing requirements is what this blog post illustrates: namely, the changed qualification requirements for study personnel and the resulting consequences, which in certain cases even lead to simplifications.

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 Trial

Underlying regulations

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

1 Introduction

The rapid development in the medical technology sector necessitates continuous 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 resulting national legislation in Germany through the Medical Devices Adaptation Act (MPAnpG) and the Medical Devices Implementation Act (MPDG) have profound implications for the planning and execution of clinical trials.

The decision of whether to opt for a single-center or multi-center design for clinical trials under Articles 62, 74, or 82 of the MDR plays a crucial role. While the MDR and the German Medical Devices Act (MPDG) introduce stricter regulations in many areas, they also offer significant simplifications in certain aspects. One such simplification pertains to the design of clinical trials. For example, approval hurdles are considerably lower for single-center studies. But what specific advantages do these offer, and what challenges and requirements arise, particularly regarding the qualifications of the necessary study personnel?

This blog post sheds light on the subject and highlights the crucial differences as well as the associated regulatory and organizational considerations in the context of clinical trial design. Particular attention is also paid to the role and requirements of study personnel, which are clearly defined and brought into focus by the new legislation.

2. Single-center study vs. multi-center study

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

The choice of design for clinical trials, whether monocentric or multicentric, 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 typically consists of one investigator. However, for larger, single-site studies or when different medical specialties are involved, the team may include multiple investigators. In this case, one investigator is designated as the principal investigator, responsible for the overall coordination of the study. Additional members of the study team, such as study nurses responsible for patient care and data collection, may also be part of the team.

Advantages of single-center studies:

• Simplicity: Since only one location is involved, the processes are generally less complex.
• Costs: Since less staff and resources are needed, the costs are usually lower.
• Control: The examiner or principal examiner has a direct overview 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.

This simplicity and cost savings can, however, be offset by the limited patient pool and geographical restrictions. There is a risk that the results will not be generalizable or that it will be difficult to recruit enough patients for the study. If a large number of patients is required according to statistical sample size planning, this design cannot be chosen, as this would then not be feasible within a reasonable timeframe.

2.2 Multicenter study

Multicenter trials are clinical trials conducted at multiple sites or centers. In such trials, the study team at each center typically consists of an investigator, a study nurse, and, if necessary, other participating professionals. Despite the multicenter structure, the procedures at each center remain similar to those of single-center trials. The difference lies in the fact that this type of study design requires a principal investigator. This principal investigator provides the principal investigator (PI), who coordinates the entire study across all centers.

Advantages of multicenter studies:

• Patient pool: The participation of multiple centers enables access to a larger and more heterogeneous patient population.
• Data basis: The design allows for broader and more representative data collection, as it draws from diverse populations and locations. Furthermore, the scientific validity is enhanced by the involvement of multiple reviewers, thus increasing external validity.
• Comparability: Different locations allow for direct comparisons and consistency checks.

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

• Key factors: Costs, effort and study staff:
• Costs: Multicenter studies can be more expensive than monocenter 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 lies in ensuring consistent protocols and practices across all centers. This particular sticking point, along with the associated considerations and strategies, will be discussed in detail below.

3. Development of qualification requirements for examiners: From the Medical Devices Act (MPG) to the Medical Devices Adaptation Act (MPAnpG)

With the evolution of the regulatory landscape for medical devices in Germany, the qualification requirements for individuals involved in conducting clinical trials have also changed.

3.1 Under the Medical Devices Act (MPG)

According to Section 20 of the German Medical Devices Act (MPG), clinical trials had to meet certain requirements. A crucial aspect was that they had to be conducted in a suitable facility and led by an "adequately qualified investigator." The MPG specified clear requirements for the investigator's qualifications: In addition to medical or dental training, they had to demonstrate at least two years of experience in the clinical investigation of medical devices.

This requirement applied to all examiners, whether examiner, chief examiner 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 personnel were specified and expanded.

Since the MPG did not contain a role definition and this had to be derived from ISO 14155 before the MPDG came into force, the MPDG now defines at least the roles of principal investigator and chief investigator in § 3 (5,6):

"According to Section 30 of the German Medical Devices Act (MDPG), there are clear distinctions between the investigator, the principal investigator, and the head of a clinical trial. While the principal investigator and the investigator continue to play important roles in clinical trials, the special qualification of at least two years of experience in the clinical investigation 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 Medical Devices Act (MPG), the qualification requirements have been made more concrete and are more specifically tailored to the different roles in the clinical trial process. This demonstrates a heightened awareness of the need for clearly defined and rigorous qualification criteria to ensure the quality and integrity of clinical trials. It also reflects the growing complexity and importance of clinical trials in the medical device development and approval process.

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 conducted. In particular, the Medical Devices Implementation Act (MPDG) has brought about some fundamental changes that affect the organization and approval of clinical trials.

One such significant change introduced into the German Medical Devices Act (MPDG) concerns the roles and qualifications of individuals involved in clinical trials. According to Section 30 of the MDPG, a distinction is now made between the investigator, the principal investigator, and the head of a clinical trial. It is crucial to understand that the previously required minimum of two years of experience in the clinical investigation of medical devices for any investigator, even in a single-center study, is now explicitly assigned only to the head of a clinical trial or other clinical trial. Thus, this requirement now applies only to multi-center studies.

While examiners and chief examiners still play important roles in the process, the special qualification requirement now only applies to the head of the audit.

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 principal investigator of a clinical trial and not on each participating investigator, the hurdle for conducting such studies is considerably lowered, as the ethics committee no longer expects this requirement from the investigator and therefore no longer checks it.

4. Conclusion

The conclusion drawn from these observations is clear: the choice between a single-center and a multi-center design has a significant impact on the approval, costs, organizational effort, and personnel requirements of a clinical trial. Proper planning and consideration of all relevant aspects are therefore essential for the success of the project. It is crucial to thoroughly examine the requirements and select the appropriate personnel for the specific study design. 

The choice between a single-center and a multi-center design has significant implications for the approval, costs, effort, and personnel requirements of a clinical trial. Proper planning and consideration of all relevant aspects are therefore essential for the project's success. It is crucial to thoroughly examine the requirements and select the appropriate personnel for the specific study design.

This aspect significantly influences the conduct of clinical trials. The Medical Devices Implementation Act (MPDG) has introduced significant changes in this regard, particularly concerning the roles and qualifications of those involved in a clinical trial.

Section 30 of the German Medical Devices Act (MDPG) and the associated clear distinction between the investigator, the principal investigator, and the head of a clinical trial have significantly simplified the approval process for single-center studies. The specification that at least two years of experience in the clinical investigation 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 for their implementation.

A thorough understanding of the legal requirements and a careful selection of suitable personnel for the specific type of study are indispensable key aspects. It is of central importance to engage intensively with these requirements and to align the planning accordingly.

This applies exclusively to clinical trials conducted under 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 invasive procedures) remain unaffected. This means that there are no such requirements for the clinical trial manager 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 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 

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