European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4th, 2017.
The MDR will replace the Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and the Medical Devices Directive (MDD 93/42/EC), while the IVDR will replace the In-Vitro Diagnostic Medical Devices Directive (IVDD 89/79/EC).
Transition period
The official transition started by publication of both regulations in the Official Journal (May 4th, 2017). This means that the implementation period officially begin on May 25th, 2017. Manufacturers of medical devices will have maximum three years (until May 25th, 2020) to comply with the Medical Device Regulations (MDR), whilst the in vitro diagnostic device manufacturers will be given five-year transition period (until May 25th, 2022).
Given numerous changes in the regulatory 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 for their medical devices.
Important dates:
May 25th, 2017: Official entry into force of MDR 2017/745 and IVDR 2017/746
March 25th , 2020: Eudamed will go live
May 25, 2020: MDR date of application
May 25, 2022: IVDR date of application
May 25, 2024: AIMD, MDD and IVDD certificates become void.
Examples of Key Changes:
* Control of high-risk devices such as implants involve also panels of independent experts at EU level
* Clinical trials taking place in more than one Member State will be subject to a single coordinated assessment
* Many aesthetic products are regulated as medical devices and subject to stricter controls
* Four out of five in vitro diagnostic medical devices are checked by a Notified Body before they are placed on the market
* European database contains extensive information on medical devices, most of which is publicly available
* An "implant card" for implanted devices gives patients more information
* A financial mechanism ensures patients are compensated in case defective medical devices harm them
* Simplified procedure allows manufacturers to register their device only once at the EU level