European Parliament Committee Signs Off on Second Round of MDR, IVDR Corrigenda

Regulatory NewsRegulatory News | 03 December 2019 |  By 

With less than six months left before the Medical Devices Regulation (MDR) takes effect, the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday voted to adopt a corrigendum that will give manufacturers of certain up-classified Class I devices an additional four years to comply.

The delay for some low-risk devices that will need to use a notified body, which sets the new deadline at 26 May 2024, was expected, as a proposal was submitted to the European Commission to change the timetable for Class I reusable devices, including some software.

Speaking before the committee vote, Biljana Borzan, a physician and member of the European Parliament for Croatia, explained 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.

“It’s a silly situation that we began in 2012 to work on this regulation and we’re running out of time. We believe it’s useful to express our dissatisfaction with the way this has been procedurally done,” Borzan added.

In addition to the corrigendum for MDR, the one for the In Vitro Diagnostic Regulation (IVDR) includes minor editorial changes, alterations related to the Eudamed delay and several additions in two annexes.

For instance, in a line in Annex III, the term “events” is changed to “incidents.” And in Annex VIII, an introductory phrase on Rule 2 now includes devices that “determine foeto-maternal blood group incompatibility.” 

This second round of corrigenda still have to be approved by Parliament, while the first round of corrigenda, which did not have to be approved by Parliament, offered further tweaks to MDR and IVDR.
MDR Corrigendum

IVDR Corrigendum

Video of Committee meeting (Vote begins around 11:33:43)


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