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?

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