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European Commission’s recent publications

Posted on 01.04.2021

As preparations continue for the application of the new medical devices Regulation (MDR) and in vitro diagnostic medical devices Regulation (IVDR), we have listed below some of the latest updates from the European Commission that can be relevant for you.

1. MDCG 2021-1 guidance on information exchange without EUDAMED
The guidance details all relevant harmonised administrative practices and alternative technical solutions for the exchange of information that will be applicable for an interim period in the absence of a fully functional EUDAMED. This period is foreseen from 26 May 2021 until May 2022 when the launch of a fully functional EUDAMED is planned.

Article 123.3d of the MDR stipulates that: “Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.”

The guidance is helpful in clarifying which actor is responsible and which tools to use for information exchange in each applicable article of the MDR.

2. Is your software a Medical Device? Infographic
The new infographic is a visualization of the process already described in detail in the MDCG 2019-11 Guidance on Qualification and Classification of Software. It covers both the process for deciding whether a software qualifies as a medical device software (MDSW) and for deciding whether MDSW falls under the MDR (EU 2017/745) or IVDR (EU 2017/746).

3. MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests

4. MDCG 2021-3 Questions and Answers on Custom-Made Devices

For more recent publications on medical devices, please check the European Commission recent newsletter.