March 27, 2023
European Commissioners have published a new Q&A resource document covering recent amendments to European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements.
To address challenges affecting the European regulatory system (paucity of Notified Bodies, protracted Notified Body review process, incomplete applications from manufacturers, et al.), the European Commission (EC) became galvanized in Q3 2022. One of the results is an amendment regulation for the MDR and IVDR.
Regulation (EU) 2023/607 was proposed in December 2022 (Emergo by UL has tracked the progress of this legislation in our regulatory updates), and was officially published March 20, 2023. As we have previously written, the EC compiled a Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 (18 questions divided into five parts).
The introduction aligns with a high-functioning medical device regulatory system: public health protection and patient safety; medical device safety and quality; and avoiding a shortage of medical devices. The amendment is intended to support sufficient time for the enterprise to be compliant. These answers should help us all make “best use of the additional time.”
The amendment only applies to legacy devices, devices that were placed on the market before the MDR Date of Application ((DoA), May 26, 2021) and fulfills additional conditions (in Article 120, as amended). New devices and legacy devices that have a significant change in design or intended purpose need to be compliant with the MDR as soon as they are placed on the EU market. Even if the manufacturer does not transition the legacy device to the MDR (no lodged assessment for conformity assessment), there is a slight benefit from the amendment: for Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) certificates that are valid on March 20, 2023 but expire before May 26, 2024, the manufacturer can continue to market to May 26, 2024. Before this amendment, the manufacturer would have had to cease marketing upon the expiration of the MDD/AIMDD certificate.
The extension of the MDD/AIMDD certificates is “done automatically by law,” provided the manufacturer is compliant with Article 120(3c). Note that one of the new conditions prescribed by Regulation 2023/607 is Article 120(3c)(e), which states that before May 26, 2024, there needs to be a formal application lodged with a Notified Body. Item 8 in the new Q&A document covers what must be addressed for a manufacturer to have lodged a formal application with a Notified Body. It should be noted that the formal application may not need to be with the legacy device (more on this later).
Furthermore, for CE certificates that expired before the amendment was published (March 20, 2023), the manufacturer must be compliant with Article 120(2) points (a) or (b): Article 120(2)(a) applies before the expiration of the certificate in instances where there was a written agreement with a Notified Body; Article 120(2)(b) applies in cases where a competent authority has issued a Derogation or Decision, in accordance with Article 59(1) or Article 97(1), respectively. There is guidance in Q&A Item 9 on the elements of a written agreement between the manufacturer and Notified Body.
A legacy device may also benefit from this extension in cases when there is a “device intended to substitute that device” per Regulation 2023/607. The EC acknowledges that this case (Q&A Item 10) is usually when “the manufacturer has made (significant) changes with regard to its design or intended purpose with a view to replacing the legacy device.” While this subsequent device needs to be compliant with the MDR before it can be marketed, the legacy device benefits from the 2027 or 2028 dates, based on classification.
The last Q&A item addresses the sell-off period. This expounds on the deletion of the sell-off period for the MDR and IVDR. Provided that the pre-DoA device was placed under the requisite conditions or the legacy device according to the deadlines in the MDR and IVDR (Article 120 or 110, respectively), and that the expiration date is still valid, the sell-off deadline doesn’t exist.
This is all good news for the EU medical device regulatory system. Provided the manufacturer adheres to the requirements, a legacy device can continue to be marketed to the end of December 2027 or December 2028, based on classification.
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