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 Device 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