On 5th April 2017 the European Parliament published an official press release announcing that New Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally adopted. This vote is the final step in the long-lasting process to update existing MDD & IVD legislations, which started in the 90s. Final texts of new Regulations are expected to be published in the Official Journal in May 2017.
Transition period
The official transition period starts 20 days after both regulations have been published in the Official Journal. This means that the implementation period should officially begin in June 2017. Manufacturers of medical devices will be then given three years (until 2020) to comply with the new requirements brought about by the New Regulation, whilst the in-vitro diagnostics devices manufacturers will be given five-year transition period (until 2022). Given numerous changes in the compliance process, especially for high-risk devices, manufacturers are strongly advised to start implementing new requirements as soon as possible in order to safeguard their EU compliance.
Key changes
New Regulations introduce much stricter rules, in particular for high-risk devices such as implants, insulin pumps or joint replacements. Some of the key changes for Medical Devices are listed below:
- New types of devices falling under the MDR
- Changes to Classification Rules
- Much stricter requirements for Notified Bodies
- Clinical Evidence
- Mandatory Post Marketing Surveillance Plan
- Extended EUDAMED Database
- Qualified Authorized Representative (EAR)
- Unique Device Identification (UDI)
- Expanded requirements for Quality Management System (QMS)
If you wish to know more about changes brought about by New MDR & IVDR, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have and will gladly assist you in safeguarding your products’ compliance.
Katarzyna Piekarska