Upcoming EU MDR Replacing MDD: Implementation and Deadlines
The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on May 25, 2017, replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD).
The MDR is scheduled to come into effect on May 26, 2020.
The MDR has a greater emphasis on hard data and clinical evaluations, which is meant to increase reliability, safety, and performance. The new requirements also mandate that devices be more traceable throughout the supply chain and device life cycle.
The law directly affects medical device manufacturers, distributors, importers, Notified Bodies, authorized representatives, the member states and the European Commission. With its vast impact, affected parties have been urgently planning and preparing for the required changes. Notified Bodies have started the designation process, while the European Commission has set deadlines for the implementation of its tasks.
The new European MDR began a 3-year transition period in May 2017. Here are some deadlines:
May 26, 2017: Official entry into force of MDR 2017/745 and IVDR 2017/746
May 26, 2020: MDR/ IVDR date of application
May 26, 2024: AIMD, MDD and IVDD certificates become void (provided they have been kept valid up until this date); after this date, no more devices may be placed on the European market under these certificates
May 26, 2025: After this date, no devices may be put into service in Europe using MDD, AIMD or IVDD certificates
What happens to MDD-certified devices in distribution after 2020?
Devices lawfully placed on the market pursuant to MDD/AIMD prior to May 26, 2020, and devices placed on the market from May 26, 2020 onward, may continue to be made available on the market or put into service until May 27, 2025 (except those issued in accordance with Annex 4 of AIMD or Annex IV of MDD). Stockpiling devices as a strategy to pursue MDR certification, has associated disadvantages - new restrictions exist when maintaining compliance under the current MDD EC certificate:
Notified Bodies can no longer accept and approve notifications of “substantial” design changes. The device cannot undergo important (and perhaps necessary) design changes, including changes to labeling/packaging, changes to the manufacturing process, or the addition of new features and functionality.
Devices must remain compliant with state-of-the-art requirements, including EU-issued common specifications and recognized standards.
New MDR postmarket surveillance (PMS) requirements must be implemented along with requirements for postmarket clinical follow-up (PMCF) or justification why PMCF is not required.
Registration requirements for all economic operators must still be completed; it will also be necessary to ensure that quality agreements are in place between the manufacturer and the Authorized Representative (AR), importer, and distributors.
No devices are grandfathered under the MDR; consequently, there will be a significant impact as the upcoming EU MDR will burden manufacturers whose devices were grandfathered prior to MDD (in distribution prior to 1993). Those manufacturers who possess grandfathered MDD devices no longer maintain their grandfathered status under the MDR.
There is some question as to whether Europe will delay implementation (some class l devices have been granted a delay.)
In July of last year, the United States urged the EU to delay the implementation of the MDR and IVDR. The U.S. cited two specific concerns:
There is an insufficient number of notified bodies to certify devices under the new regulations.
The EU has drafted an insufficient number of the implementing acts needed to provide details about how the industry can ensure their products comply with new standards.
The EU, however, commented in July 2019: “There are no grounds for the time being to explore any amendment to the transitional periods.” A delay is unlikely, so conformity to the new MDR requirements starts May 26th.