Medical Devices
Regulation (EU) 2017/745 on Medical Devices (Medical Devices Regulation – MDR) entered into force on 26.05.2021. It has replaced Medical Devices Directive 93/42/EEC (MDD) and also Directive 90/385/EEC (on active implantable medical Devices-AIMDD).
The new regulation means that Medical Devices Manufacturers have to fulfil stricter requirements in order to sell their products in the EU. Among others, the rules for conformity assessment procedures, which require the involvement of a Notified Body, have been tightened. TÜV NORD continues to be one of the European Notified Bodies qualified for these procedures, as it was under the old legislation (Designation scope TÜV NORD CERT at NANDO).
Secure your access to the European market now and contact us in good time for certification to the new MDR.
The MDR certification is relevant for medical device manufacturers, importers, distributors, and developers who must comply with the requirements of the Medical Device Regulation (MDR 2017/745). It applies to companies of all sizes that market or distribute medical devices in the EU.