Introductory text

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC^f1, and in particular Article 106(1) thereof

Whereas:

Expert panels are to be designated in order to provide scientific, technical and clinical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States, notified bodies and manufacturers in relation to the implementation of Regulation (EU) 2017/745 and in order to provide views in accordance with Article 48(6) of Regulation (EU) 2017/746 of the European Parliament and of the Council^f2.

In particular, notified bodies are required to carry out consultations of expert panels on clinical evaluations of certain high-risk medical devices in the context of Regulation (EU) 2017/745 and on performance evaluations of certain high-risk in vitro diagnostic medical devices in the context of Regulation (EU) 2017/746.

The Commission has, in consultation with the MDCG, identified areas in which the provision of consistent scientific, technical and/or clinical advice is needed. Expert panels should be designated in those areas and the principles of their organisation and operation should be defined, including the procedures for the selection and appointment of their members, as to ensure that they work according to the highest scientific competence, impartiality, independence and transparency. The list of designated expert panels can be revised, based on experience or newly identified needs.

The advisors in the expert panels should be appointed on the basis of objective criteria and following a public call for expression of interest. The selection criteria included in the call for expression of interest should ensure that highly qualified advisors with a sufficient level of up-to-date clinical, scientific or technical expertise in the relevant identified areas are selected, and that advisors are able to act independently and in the public interest. The selection criteria should also ensure that the collective expertise of all advisors selected adequately covers all the identified areas and that the geographical origin of the advisors reflects the diversity of scientific and clinical approaches in the Union.

The number of advisors to be appointed to each expert panel or included in the central list of available experts should be specified in the call for expression of interest, based on expected workload and necessary expertise.

The organisation of the expert panels should ensure flexibility so that specialised knowledge can be deployed based on requisite needs. In addition to advisors appointed to expert panels, a central list of advisors who are not members of expert panels should therefore be established. Advisors on that list should be available to support the work of the expert panels as needed.

In order to ensure timely and efficient exercise of their tasks, the expert panels should be able to establish sub-groups entrusted with specific tasks and composed of a certain number of their members.

In order to facilitate the organisation of the expert panels and the communication between them, a coordination committee composed of the Chairs and Vice-Chairs of the panels should be established. In order to ensure the support necessary for the efficient functioning of the expert panels, the Commission should provide a secretariat for the expert panels and for the coordination committee.

Expert panels should operate in a transparent and harmonised manner. To this end, common rules of procedure, internal guidance and methodologies for their operation should be established by the coordination committee and be publicly accessible. The common rules of procedure, the internal guidance and the methodologies should be reviewed regularly to ensure that they take account of the latest scientific developments and reflect state-of-the-art practice.

Any personal data treated by the expert panels, the Secretariat or the coordination committee is to be processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council^f3.

Advisors should comply with the rules on security regarding the protection of Union classified information and sensitive non-classified information, laid down in Commission Decisions (EU, Euratom) 2015/443^f4 and (EU, Euratom) 2015/444^f5.

Given the contribution of expert panels to achieve the objectives of Union policies, by providing scientific, technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of Regulation (EU) 2017/745 and of Regulation (EU) 2017/746, and taking into account the principle of cost-effectiveness, advisors should receive adequate remuneration for their activities, beyond reimbursement of expenses. The level of remuneration should reflect the extent of work required from the advisors, notably in relation to the duration and nature of their tasks.

The financing of the expert panel activities should be provided by the relevant budget line of the Commission,

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