Device Industry, Notified Bodies to Offer Feedback to MDCG at MDR Meetings Next Month

Regulatory NewsRegulatory News | 28 February 2020 |  By 

The European Commission’s Medical Device Coordination Group (MDCG) on 11, 12 March will hold a series of meetings, partly to hear additional feedback from industry and notified bodies on their preparedness for the application of the Medical Devices Regulation (MDR) on 26 May.

Following a previous meeting between industry and the MDCG on 30 September, this next set will focus on MDR implementing acts, updates on MDCG subgroups, as well as a progress report on the process for designating notified bodies under MDR and the In Vitro Diagnostic Regulation (IVDR), according to the draft agenda.

Expert panels, the Eudamed database and developments with regard to guidance on the Medical Device Single Audit Program will also be discussed.

As part of the meetings across both days, none of which are open to the public, the MDCG is also expected to hold a high-level meeting that will discuss the Eudamed database, which because it will only be operational once all modules are fully functional and an independent audit has been conducted, the European Commission decided to launch simultaneously for both medical devices and in vitro diagnostics in May 2022.

Later in the afternoons on both 11 March and 12 March, the MDCG will also discuss notified bodies, as well as transitional provisions on: “a) Guidance on significant changes [Art. 120.3 (EU) 2017/745] with regard to devices covered by certificates according to 90/385/EEC or 93/42/EEC – for endorsement b) Class I transitional provisions in Article 120 (3)(4) – for endorsement c) Guidance on transitional provisions for consultations of authorities on devices containing ancillary medicinal products and on devices manufactured using TSE susceptible animal tissues – for information.”

On the topic of clinical evaluation and performance evaluation, the MDCG is further expected to discuss the endorsement of guidance related to device software, and hear information on guidance on clinical evidence requirements needed for devices previously certified under Directives 93/42/EEC and 90/385/EEC, known as legacy devices.

The meetings will also hold an exchange of views on the market situation in the EU, as well as further discussions on setting up expert panels and transparency obligations.

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