The medical device industry landscape of regulations is constantly changing. The European Union’s Medical Device Regulations (EU MDR) came into effect on 26 May 2021 after a three-year transition period, is no exception. The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). The requirements for market access of medical devices, the life cycle of the devices, and Notified Bodies will significantly increase. Therefore, this date is a turning point for the medical device industry in Germany and Europe.
When we look specifically at the Quality Management System (QMS) requirements for the EU MDR transition, they are detailed in Article 10 (9) of EU MDR. For those companies familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, the resemblance with Article 10(9) will immediately stand out. EU MDR is the gold standard for medical device regulation due to the recent scientific and technological progress. While cultivating innovation and promoting competitiveness in the medical device industry, the new regulations will further ensure safety and effectiveness via tighter controls. In order for manufacturers to have enough time to make the necessary changes, this gradual transition was implemented, and will quickly arrive sooner than later.
European Union Medical Devices Regulation (2017/745/ EU) (MDR) transition represents a major update to the Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD) from the 1990s. EU MDR was adopted in April 2017, the start of the transition period that ended with the date of application, May 26, 2021. (EU IVDR, the new rules for in vitro diagnostic medical devices, took effect May 2022.) Regardless of where the devices are made, the EU MDR affects all device manufacturers that supply products to the European market.
- May 2020 – completion deadline for the MDR
- May 2022 – EC compliance certificates issued before May 27, 2017, expire
- May 2024 – Available for all EC certificates issued five years from the date of issue/renewal, or four years from the application date of the MDR (May 27, 2020), whichever comes first
- May 2025 – Can no longer sell or distribute devices certified under the MDD
PLAN THE TRANSITION
Have the entire team study the 35 pages of instructions addressed to the Notified Bodies
Read the “whereas section” before article 1.
CONDUCT A GAP ASSESSMENT
Will classifications change?
Are these products covered by the MDR?
Any products not currently marketed under MDD, will they be covered under MDR?
EXAMINE YOUR PORTFOLIO
Time and resource investment needed to upgrade the QMS?
What products can continue to stay on the market?
Can any products can be put on hold?
How are the necessary supplier changes affected by the signed contracts?
DEVELOP AN ACTION PLAN
What should be implemented centrally, and what should be left to individual business units and divisions?
How will accountability be established between the two?
What will be handled by the legal producer versus subcontractors?
Is now the time to integrate particular subcontractors into the company?
SUPPORT YOUR TRANSITION WITH EFFECTIVE TRAINING
IMPLEMENT YOUR TRANSITION PROGRAM
NEW QUALITY SYSTEM MANAGEMENT (QMS) REQUIREMENT
GETTING MANAGEMENT ON-BOARD
HOW AND WHERE THIRD-PARTY EXPERTS OFFER VALUE
If you are seeking staffing assistance for your transition of requirements for EU MDR transition, reach out to Precision Life Sciences for all your needs. We will be able to fill those gaps and help you complete your project on time.