The first deadline for Regulation 2023/607 is rapidly approaching. Manufacturers of legacy medical devices sold in the EU market will receive a regulatory reprieve when Regulation 2023/607 System and Procedure Packs goes into effect May 26, as long as certain conditions are met.
About Regulation 2023/607
We briefly share again the requirements for Regulation 2023/607 amending the European Medical Devices Regulation (2017/745, MDR). Manufacturers must have an application with a notified body designated for the MDR for the legacy (or substitute) devices by May 26, 2024, a quality management system and an agreement with said notified body by September 26, 2024. There must continue to be no significant changes in design and intended use, the MDCG guidance 2020-3 may be an asset here.
What are the extended timeframes for legacy devices?
Legacy device manufacturers, by definition, placed the devices on the EU market before the MDR Date of Application (DoA). In addition, the manufacturer has the requisite documents with the notified body, and continues to make no significant changes in design and intended use to the legacy device. There are other provisions though these are the most salient.
If the manufacturers of the legacy devices are compliant, the legacy devices benefit from the following extended deadlines, at which point the devices must be compliant with all aspects of the MDR, to continue to be placed on the market.
- December 31, 2027, for all class III devices, class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
- December 31, 2028, for class IIb devices (non-implantable), class IIa devices, and for class I Sterile/Measurement/Reusable surgical instrument
Note for Class I self-certified to the directive and up classified by the MDR, the new classification per the MDR, determines the deadline. We expect it to happen by the end of 2028.
EU Update: Deadline nears for medical device Regu|ation 2023/607 Emergo by UL
EU Update: Deadline nears for medical device Regulation 2023/607
We briefly share again the requirements for Regulation 2023/607 amending the European Medical Devices Regulation (2017/745, MDR). Manufacturers must have an application with a notified body designated for the MDR for the legacy (or substitute) devices by M
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