Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union.
The Medical Device Regulation (MDR) entered into force in 2017 replacing the existing Directives for medical devices (93/42/EEC and 90/385/EEC). It aims to ensure the smooth functioning of the internal market as regards medical devices, for a high-level protection of health for patients and users. At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns related to such products.
Before the entry into force of the MDR, there were discrepancies in the categorisation of medical devices across Europe and the lack of specific guidelines. Now, according to the MDR, a medical device is “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used, alone or in combination, for human beings for specific medical purposes”.
The key changes of the MDR include: the amended classification of medical devices (non-medical devices, such as dermal fillers and contact lenses, with similar risk profiles to medical devices in analogous classes will be within scope); a Unique Device Identification number for each medical device and a database of medical devices in the EU market (Eudamed); pre-market scrutiny through harmonised standards and common specifications as well as new requirements for manufacturers to make publicly available post-market or safety surveillance reports; the appointment of qualified persons from the manufacturers, more extensive powers from national notified bodies, and establishment of authorised representatives from non-EU countries to ensure conformity with the regulations.
To support the implementation of the MDR, updated guidance on quality requirements for human medicines including a medical device, as well as a Question & Answer (Q&A), are currently under preparation and will be published shortly.
Discover more by reading the Regulation here.
Stay tuned for further updates!