EU adopts Medical Device Regulations
On 5 April, two new regulations on medical devices were adopted by the EU namely EU2017/745 and EU2017/746. These replace the existing Directives for Medical Devices and In-Vitro Medical Devices, respectively i.e. 90/385/EEC and 93/42/EEC, 98/79/EC 2010/227/EU.
These regulations were published May 5, 2017 in the Official Journal of the European Union (OJEU) and 'entered into force' occurred on May 26, 2017.
The new rules will only apply after a transitional period, namely 3 years after 'entry into force' for the Regulation on Medical Devices (i.e. 2020) and 5 years after 'entry into force' (i.e. 2022) for the Regulation on In-Vitro Diagnostic Medical Devices.
The new regulations contain a series of extremely important improvements to modernise the current system.
The new Regulations in a nutshell
- Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
- Reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
- Inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these regulations;
- Introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
- Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
- Introduction of an “implant card” containing information about implanted medical devices for a patient;
- Reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations;
- Strengthening of post-market surveillance requirements for manufacturers;
- Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
The new regulations will ensure:
- A consistently high level of health and safety protection for EU citizens using these products;
- Free and fair trade of the products throughout the EU;
- That EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.