Extension of the MDR transitional period
New EU Regulation 2023/607 has come into force on March 20, 2023, affecting medical device manufacturers. The regulation has impacted the extension of the transition period for the Medical Device Regulation (MDR) and Active Implantable Medical Devices Directive (AIMDD) and Medical Devices Directive (MDD) certificates. In this article, we discuss the impacts of this regulation on device manufacturers.
The first change concerns the extension of MDR transition periods. For higher-risk devices, the period is now extended until December 31, 2027, while for medium and lower-risk devices, the period is extended until December 31, 2028. However, this extension only applies to "legacy devices" under certain conditions. These include that the device must comply with AIMDD/MDD, there must be no significant changes in design and intended purpose, and no unacceptable risks to health or safety of patients, users, or other persons. Manufacturers must also have established an MDR-compliant Quality Management System (QMS) and lodged a formal application for Notified Body MDR conformity assessment.
For manufacturers whose certificates expired, there are certain conditions that apply. The manufacturer must have signed a contract with a Notified Body for MDR conformity assessment, or a national competent authority must have granted a derogation from the applicable conformity assessment procedure under Article 59, or a national competent authority must have required the manufacturer to carry out conformity assessment within a specific time period under Article 97.
Certificates will remain valid for the duration of the extended transition period if these conditions are met.
During the extended transition period, manufacturers must comply with the MDR's vigilance and PMS requirements. However, they must also establish technical documentation to demonstrate conformity with AIMDD/MDD and MDR requirements depending on when the Notified Body is ready to begin technical file assessment. This documentation must be reflected in the relevant QMS documentation to be in place by May 26, 2024.
Lastly, there has been a deletion of the "sell-off" dates.
In essence, products that have been placed on the market in the Union prior to the expiration of their certification can be sold indefinitely. However, it's important to keep in mind that their shelf life is ultimately limited by factors such as sterility expiration dates.
You can find the Q&A on practical aspects related to the extension of the MDR transitional period here.