European Commission Expert Panels: Overview
At the beginning of November, the European medical device regulating authority, the European Commission (EC), announced that it will be extending the period for accepting applications from experts interested in joining expert panels. Medical device and in vitro diagnostic medical device panels are the special advisory bodies that consult notified bodies during the certification of high-risk medical devices. Expert panels are designated by the European Commission and the Medical Device Coordination Group (MDCG). There will be 11 separate expert panels that can work both independently or cooperatively if it was found necessary due to the nature of the issue being faced. The number of experts in each of the panels differs depending on the scope of work and expected workload.
According to the applicable regulations, expert panels must consult notified bodies regarding clinical evaluation assessment before placing certain medical devices on the market and must consult on performance evaluation for some of the in vitro diagnostic medical devices. In accordance with the applicable regulations, EC expert panels would also be responsible for performing the following functions:
- Responding to the requests for consultations of medical device manufacturers on issues associated with clinical development strategy,
- Provide advice and consultations to national regulating authorities, notified bodies and medical device manufactures on all issues related to medical device assessment in general and clinical evaluation issues in particular,
- Provide technical, scientific and clinical assistance to the EU regulating authorities and medical device manufacturers,
- Provide assistance of the evaluation of safety of medical devices, and
- Perform other functions specified in regulations.
The intention is that experts will be able to provide technical and scientific advice in the case that the specialists from notified bodies lack the qualifications to evaluate the application properly and to assess all possible risks associated with the use of the particular medical device. The experts would then have to provide independent advice on the most complicated issues related to medical device certification process. They would also participate in the development of guidances and regulations or other regulatory documents (e.g. standards) regarding various categories of medical devices.
Application Process and Requirements
According to the call for applications, published by the EC, all applications could be submitted in electronic form. Each application must contain:
- a detailed curriculum vitae (CV) describing the professional experience of the expert,
- a copy of the document identifying the personality of the expert and his/her nationality, such as passport or other ID, and
- a Declaration of Interests (DOI) – important document describing the existing connections with any parties involved.
DOI was implemented to identify grounds for potential conflicts of interest. In this document an applicant must promptly disclose any connection that could facilitate a conflict of interest when acting as a member of an expert panel. The application form itself contains detailed personal information of an applicant, information on previous work experiences (at least 5), activities and associated responsibilities, and information on the particular sphere of professional activity, such as academic research or medical device industry or any other sphere.
To meet the eligibility criteria, an expert applying to become a member of the expert panel must:
- Be a citizen of EU Member state, EFTA Member state or Turkey,
- Have an appropriate university degree in one of the relevant areas,
- Have at least 10 confirmed years of relevant professional experience in particular sphere of healthcare,
- Hold a proficient level of knowledge of the English language allowing him/her to communicate easily and participate in negotiations and to draft documents and reports in the course of professional activity.
An applicant should also describe in detail his professional experience related to different areas of healthcare, including any relevant experience related to medical devices. It is also necessary to inform about existing advising experience or participation in any committee or other advisory body of any regulating authority. When submitting the Declaration of Interest, an applicant must disclose any previous experience of being an executive officer in a medical device company within the previous 3 years. Specifically, DOI should contain information on any connections with medical device companies existing previously in any form, such as employment, consultancy, strategic advisory, financial interest, principal investigation (investigator), funding, close family member interest, or any other relevant information. For the purpose of the documents an investigator means the person involved in medical device investigation works on a paid basis, while principal investigator means there is one person coordinating the work of several investigators.
The Reason for Extension
According to the information available, the reason for extension of the application period was because there was a lack of applications – the EC failed to obtain the number of applications necessary to engage the appropriate number of experts. As it was mentioned by the representatives of the Eudamed, the entity operating the newly introduced medical device database, there are two main reasons that contributed to the current situation:
- The rules on conflict of interest are too strict, and
- The remuneration offered by the EC is too low to be interesting for the specialists having the appropriate professional experience.
It is quite difficult for any medical device professional with relevant background in relevant spheres to comply with these rules since it is almost impossible to obtain the experience necessary without obtaining any connections with particular medical device companies. At the same time, the conflict of interest rules are aimed to prevent any possible conflicts of interest and are important to create a body that would be able to provide impartial and unbiased advice. However, the number of experts with connections that are weak enough to allow them to apply as expert panel members is too small, making the whole process much more difficult. Another important point is the remuneration offered by the EC. According to information from various sources, this remuneration could be lower than the average remuneration of the experts having this specific level of professional knowledge and experience. This makes it unreasonable for the high-level experts to dedicate their time and efforts to the participation in the activities held by the expert panels.
It is also important to mention that it is not the only delay initiated by the European Commission relating to the implementation of the new medical device regulations (the MDR and the IVDR). As it was announced previously, earlier in October, the European Commission informed on the delay in the implementation of the new medical device database, Eudamed. At the same time, the new medical device regulations would take effect in less than six months. That is why it is very important for medical device manufacturers to be informed on the main amendments and events that may impact the regulatory framework to be able to maintain compliance despite the existing regulatory uncertainty.
How RegDesk Can Help
RegDesk™ is a next generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash™ . Global expansion has never been this simple.
Sources:
