German Medical Technology Association reports on the impact which the MDR will have on users and operators of medical devices

Miriam Schuh

Devices for which a notified body needs to be involved for the conformity assessment procedure under the previous legal framework (MDD/AIMDD) (PDF) may take advantage of a transitional period through May 2025 at the latest, provided their certificate of conformity remains valid.

This transitional period also benefits all Class I devices (cf. 2nd Corrigendum to the MDR) which will require a notified body for certification once the MDR takes effect.

This applies to reusable surgical instruments (newly classified as Class I) as well as higher-classified medical software, medical devices which contain nanomaterials and substance-based medical devices.

Paradoxically, this transitional period generally does not apply for Class I devices, i.e. for whose which, by definition, are viewed as least risky to patients and users, so that further cooperation with a notified body is unnecessary. Class I devices are required to fully comply with the MDR (PDF) as of 26 May 2020.

[February 2020]