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