MDR – Article 105 – Tasks of the MDCG

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 aimed at ensuring
effective and harmonised implementation of this Regulation, in
particular regarding the designation and monitoring of notified
bodies, application of the general safety and performance
requirements and conduct of clinical evaluations and investigationsby manufacturers, assessment by notified bodies and vigilance
activities;
(d)to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance
requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to ensure safety and performance of devices, and
thereby contribute to identifying whether there is a need to amend Annex I to this Regulation;
(e)to contribute to the development of device standards, of CS and of
scientific guidelines, including product specific guidelines, on
clinical investigation of certain devices in particular implantable
devices and class III devices;
(f)to assist the competent authorities of the Member States in their
coordination activities in particular in the fields of classification andthe determination of the regulatory status of devices, clinical
investigations, vigilance and market surveillance including the
development and maintenance of a framework for a European
market surveillance programme with the objective of achieving
efficiency and harmonisation of market surveillance in the Union, in accordance with Article 93;
(g)to provide advice, either on its own initiative or at request of the
Commission, in the assessment of any issue related to the
implementation of this Regulation;
(h)to contribute to harmonised administrative practice with regard to
devices in the Member States.

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