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Minutes

Agenda of the MDCG and the MDCG subgroups has been released!

The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below).  Most likely we will see an increase of new documents and hopefully new notified bodies after each MDCG meeting.  





Article 103 Medical Devcie Coordinating Group.
1. A Medical Device Coordination Group (‘MDCG’) is hereby established.



2. Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise …



The members of the MDCG shall be chosen for their competence and experience …
The alternates shall represent and vote for the members in their absence.
3. The MDCG shall meet at regular intervals …
4. The MDCG shall use its best endeavors to reach consensus. …
5. The MDCG shall be chaired by a representative of the Commission. …
6. The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions.
7. The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations representing the interests … in the capacity of observers.
8. The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
— the adoption of opinions or recommendations or other positions, including in cases of urgency;
— the delegation of tasks to reporting and co-reporting members;
— the implementation of Article 107 regarding conflict of interests;
— the functioning of sub-groups.
14. The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation





Article 105 - Tasks of the MDCG
Under this Regulation, the MDCG shall have the following tasks:
(a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
(b) to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
(c) to contribute to the development of guidance …
(d) to contribute to the continuous monitoring of technical progress …
(e) to contribute to the development of device standards, of CS and of scientific guidelines, …
(f) to assist the competent authorities of the Member States in their coordination activities …
(g) to provide advice, either on its own initiative or at request of the Commission, …
(h) to contribute to harmonised administrative practice with regard to devices in the Member States.

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