January 31, 2024
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.
What documents should be included in a package to demonstrate compliance with Regulation 2023/607?
The following documents should be included in a comprehensive package:
- Manufacturer’s Declaration with Regulation 2023/607
- Application with the notified body designated to the MDR
- Agreement with the notified body designated to the MDR or letter from the notified body confirming eligibility of the extension
- Signed Declaration to the Directive, to support legacy device status
- CE marking certificate with the Directive (expired after March 20, 2023)
- Alternatively, a signed MDR transition Agreement with your notified body dated prior to March 20, 2023, or an Article 59 MDR derogation or 97 MDR decision prior to March 20, 2023 can be provided
- Classification rational document with the MDR
What are some commonly identified issues related to compliance with Regulation 2023/607
If your current notified body to the directives is not designated to the MDR, to continue to place the legacy device on the market, you must engage a notified body designated for the MDR before May 26, 2024.
The devices which are subject to the MDR application must be aligned and explicit to the legacy devices, unless there is a substitute device in which case, it must be clear which legacy devices the substitute devices replace.
If there are changes to the manufacturer or to the legacy device, these changes should be reviewed to the MDCG guidance to confirm that the changes are not considered significant and the legacy device can continue to be placed on the market.
What resources do we recommend?
The European Commission (EC) has organized most of the collateral related to Regulation 2023/607 under the “New Regulations” section. The documents of note: Regulation 2023/607, EC Question and Answer on Practical Aspects, the template for notified bodies, and the template for manufacturer’s declaration.
In addition, Emergo hosted a webinar on this topic and the recording is now available.
The first deadline for an application with a notified body designated to the MDR is rapidly approaching. To continue to place your legacy device on the market, this application is required. After that, the agreement with the notified body needs to exist.
Both the application and the agreement are critical elements to capitalize on the extended transition timeframes.
Please do not delay, as the deadlines are rapidly approaching.
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