The new Medical Device Regulation (EU) 2017/745 came into force on May 5, 2017. The transition period for this regulation is 3 years. By May 2020, the medical device companies must implement these regulatory changes.
Even though innovative progresses are being made in the field of medical device technology, there is growing concern over the risk of medical and diagnostic devices on human body. The new medical device regulation aims at ensuring greater patient safety.
The Medical Devices Coordination Group (GCDM) will be responsible for enforcing the regulations through scrutiny mechanism. It allows them to review a Notified Body’s assessment of high-risk devices.
Below are the major changes brought in:
|May 2017||MDR published, the 3-year transition period begins.|
|January 2019||MDSAP certification of the QMS for manufacturers of Class II, III, and IV medical devices required|
|March 2019||Transition deadline for ISO 13485:2016 in Europe, The United Kingdom (possibly) leaves the European Union, a transitional period may start (Brexit)|
|March 2020||EUDAMED (EU Database Medical Devices) goes live (however, there are provisions for delay)|
MDR becomes applicable and enforceable:
|May 2021||UDI must be placed on the label of Class III devices that are MDR certified|
|May 2022||Certificates issued in accordance with Annex 4 of AIMDD and Annex IV of MDD that have not yet|
|May 2023||UDI must be placed on the label of Class IIa and Class IIb devices that are MDR certified|
|May 2024||Other certificates issued under current Directives that have not yet expired will become void|
|May 2025||Devices that were CE marked under the MDD or AIMDD may no longer be marketed or put into service in Europe. UDI must be placed on the label of Class I devices|
Do you want to learn more about Medical Devices Regulation and comply with the regulation before deadline? Talk to the compliance experts at ComplianceXL.