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

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…