The conformity assessment procedures for medical devices
The confirmation of the conformity of a medical device is essential for market entry. If the conformity with the valid requirements of the EU cannot be demonstrated, the medical device manufacturer may not place a CE mark on the device and thus cannot bring the product on the market.
The correct route for the conformity assessment procedure depends on the valid legal basis for medical devices. Currently, two EU regulations are in force, as there is a transitional period until the new EU Medical Device Regulation comes into application. Up to 25 May 2021, the EU Medical Devices Directive 93/42/EEC is still applicable. Beyond this date, certified and registered medical devices can still be sold for 4 years without the manufacturer being allowed to make relevant changes.
The European Regulation on Medical Devices (MDR) 2017/745 and 2017/746 on in-vitro diagnostics will apply with the cut-off date of 26 May 2021. If a Notified Body is already designated for certification procedures according to MDR and a contractual relationship exists between this body and a manufacturer, CE-certification according to the Medical Devices Regulation can take place. Accordingly, manufacturers can currently carry out conformity assessment between two European legal frameworks.
However, the necessary requirements do not differ significantly. The requirements to be fulfilled are termed Essential Requirements in the MDD (Annex I), whereas the MDR describes them as Essential Safety and Performance Requirements (cf. Annex I). Every manufacturer must fulfil these for their medical devices! The respective conformity assessment procedures (MDD Annexes II-VI; MDR: Annexes IX-XI) determine which further aspects must also be considered. The choice for the appropriate procedure depends on the classification of the medical device. The following figure shows the options available to medical device manufacturers.
After a successful conformity assessment procedure, the manufacturer can issue a declaration of conformity and sign the respective device with a CE marking according to Annex XII (MDD) or Annex V (MDR).
If you would like to find the right conformity assessment procedure for your medical device, please contact us! We are happy to support you! If you wish, we can accompany you through the entire certification process. You set the pace and the type of cooperation!