European Parliament Adopts Second Round of MDR, IVDR Corrigenda

Regulatory NewsRegulatory News | 17 December 2019 |  By 

The European Parliament has adopted a second corrigenda for the EU’s incoming Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), offering certain up-classified Class I devices an additional four years to comply with MDR.

European Parliament spokesperson Thomas Haahr confirmed to Focus on Tuesday that no votes were requested before the deadline, so the corrigenda are adopted.

A managing director of a UK-based manufacturer of up-classified devices, who requested to remain anonymous, told Focus: "The second corrigendum is incredibly important to our business continuity."

The delay will provide more time for manufacturers of low-risk devices, including surgical tools and software, which will need to be submitted to a notified body. The adopted corrigenda now sets that new deadline at 26 May 2024.

What’s unusual about this set of corrigenda is that they change the substance of MDR.

Biljana Borzan, a physician and member of the European Parliament for Croatia, explained two weeks ago how corrigenda are typically used to correct technicalities, but in the case of MDR, the changes are substantial. And although she recommended supporting the changes, she also noted how unusual it is to alter the substance of the regulation with a corrigendum.

The first round of corrigenda, meanwhile, fixed the mistakes and inconsistencies and slightly corrected some of the MDR and IVDR texts.

But device companies should not expect other deadlines to change between now and 26 May 2020. European Commissioner for Health Stella Kyriakides said last week that that deadline is not changing, but she said companies should be on the lookout for implementing acts, more notified body designations and possible solutions to help with the Eudamed delay.


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