January 31, 2024
Regulation 2023/607 amending the European Medical Devices Regulation (2017/745, MDR) has been released. This is a reprieve for legacy medical devices, provided the manufacturer addresses the conditions in the amending legislation.
Generally, manufacturers must have an application with a notified body designated to the MDR for the legacy (or substitute) devices by May 26, 2024 and a quality management system, as well as an agreement with said notified body by September 26, 2024.
Great news for legacy medical devices
This is of course great news for legacy device manufacturers (no significant changes in design and intended use) as this theoretically affords additional time (until the end of December 2027 and the end of December 2028, based on risk classification).
What is an SPP?
An SPP is an assembler or producer of a system and procedure pack for medical devices.
About MDR Article 22 System and Procedure Packs
Article 22 of the MDR on System and Procedure Packs was essentially the Medical Devices Directive MDD 93/42/EEC, Article 12. The greatest confusion seems to revolve around the MDR Date of Application (DoA) and whether an assembler can continue to use an MDD Article 12 Declaration or have to issue an MDR Article 22 Declaration.
Now, about three years after the DoA, assemblers would only issue MDR Article 22 Declarations, though it is plausible that there are legacy devices that are included.
Are you an assembler of an MDR Article 22 SPP?
To continue to place the MDR Article 22 SPP on the market and assemble the SPP, the devices included in the SPP need to be compliant with the MDR for an MDD legacy device (a device with an extended validity date).
Have you approached the manufacturers of the legacy devices in your SPPs to verify the following?:
- If the MDD or AIMDD CE marking certificate expired, it expired after March 20, 2023
- By May 26, 2024, the manufacturer has an application with a notified body designated for the MDR
- By September 26, 2024, the manufacturer has a contract with the notified body
- There have been and will not be any “significant changes in design or intended purpose”
We suggest that you request and keep on file the manufacturer’s self-declaration to Regulation 2023/607, as well as any additional evidence, for legacy devices within the SPP.
While this has always been the case, assemblers of SPPs should confirm that they can continue to assemble the devices within their Article 22 SPP. As the latest validity of a notified body issued MDD CE marking certificate is May 26, 2024, assemblers must demonstrate that they can continue to assemble the Article 22 SPP and place it on the market or identify suitable alternatives.
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