Council gives green light to launch negotiations on MDR delay + MDCG Guidance on NB audits during COVID-19

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 . . .

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