Transitional provisions for legacy devices

The amendment extended the period during which devices covered by a valid directive certificate may continue to be placed on the market, with the end date depending on the device class and on the validity of the underlying certificate.

The extension is conditional. Manufacturers must have applied to a notified body for MDR certification before the relevant date, and the notified body must have confirmed receipt in writing. A quality management system certificate under the MDR is also required for the device concerned.

Devices benefiting from the extension remain subject to post-market surveillance, vigilance and registration obligations under the MDR, including UDI assignment and entry into EUDAMED. Significant changes to design or intended purpose remove the device from the transitional regime.

Notified bodies were given additional time to complete assessment of legacy files, and the regulation introduced a mechanism to transfer certification files between notified bodies where a manufacturer changes provider.