The Council of the European Union agreed today to a Mandate for launch of negotiations with the European Parliament to delay MDR under urgent procedure.
The Council of the EU generally accepts the Commission proposal to delay the MDR, nevertheless proposes amendments to Article 120(3) of the MDR that has created certain confusion especially for the manufacturers (of up-classified, reusable surgical instruments devices) that could newly enjoy the grace period – following the Second Corrigendum to the MDR:
The Council is proposing amendment to Article 120 (6) and 120 (10) of the MDR:
Additionally, there are proposed changes to Article 123 (3).
All amendments and changes are available on the following link: Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions – Mandate for negotiations with the European Parliament and the COR 1 that was sent to Permanent Representatives Committe and agreed upon.
It is expected that the European Parliament will be voting on its position at first reading on April 16. Then the Proposal will go back to the Council. In addition, mandatory consultation shall be performed by the European Economic and Social Committee and the Committee of the Regions and finished before this Regulation is adopted. Both Committees are involved as the Proposal concerns public health.
Today, the MDCG also released a Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions as the most recent response to COVID-19 outbreak, which is immediately applicable and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation.
It is also specified that the Guidance is applicable mainly for the ”old” Directives, however it may also apply for the MDR and IVDR in the event that the availability of devices is affected by COVID-19 restrictions. Full document here.
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