With less than six months left before the Medical Devices Regulation (MDR, 2017/745) takes effect, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) has voted to adopt a second MDR corrigendum that will give manufacturers of certain up-classified Class I devices an additional four years to comply. This delay for some low-risk devices that will need to use a notified body under the MDR sets a new compliance deadline of 26 May 2024.
In addition to the corrigendum for MDR, the one for the In Vitro Diagnostics Regulation (IVDR, 2017/746) includes minor editorial changes, alterations related to the two-year Eudamed delay, and several additions in two annexes.
While ENVI has cleared the corrigenda, it must be remembered that they still have to be approved by Parliament, and also that the member states are voicing objections to the two-year Eudamed delay, seeking a review as to whether certain Eudamed modules can be introduced earlier. Watch this space!