Help is at hand for manufacturers of medical devices: New “Manufacturer's Declaration” form

Previously, medical devices had to be in compliance with the rules of Directive 90/385 on active implantable medical devices (“AIMDD”) as well as Directive 93/42 on medical devices (“MDD”). With the introduction of Regulation 2017/745 on medical devices (“MDR”) and Regulation 2017/746 on in vitro diagnostic medical devices (“IVDR”) which entered into force on 26 May 2021 and 26 May 2022, respectively, medical devices now have to live up to even stricter requirements. 

However, a transitional period has been provided, so that certain types of medical devices, on certain conditions, do not have to live up to the provisions of the MDR and the IVDR yet. This applies to the so-called “legacy” medical devices comprised by the MDR and IVDR, where the new regulations stipulate that a notified body must be involved in the process of drafting a declaration of conformity. Any other devices, meaning new devices placed on the market after the regulations entered into force as well as devices comprised by (i) class I which are not in sterile state, have a measuring function or are reusable surgical instruments, and (ii) medical devices comprised by IVDR class A which are not being marketed in a sterile state, are not comprised by the transitional period and must therefore comply with the rules of the MDR and the IVDR already.

MedTech Europe has prepared a form (Manufacturer's Declaration) that can be used as a practical instrument to follow the rules of the MDR and IVDR, including the transitional provisions. By using and completing the form, the manufacturer makes a declaration about:

• The validity of certificates issued under the AIMDD and the MDD
• The compliance of the devices and their manufacturer with the conditions for the continued placing on the market and putting into service.

You can find the MedTech Europe form here.