EU Regulation 607/2023: Extension of certificates and marketing for medical devices – Clarification and conditions
On March 20, 2023, EU Regulation 607/2023 was published in the Official Journal of the European Community, extending the transitional period for medical device certificates and market entry, eliminating the sell-off period.
On March 24, the Q&A document on practical aspects related to the implementation of Regulation (EU) 2023/607 was published on the European Community website, providing clarifications on the application of the aforementioned regulation. This document addresses concerns previously mentioned in the article.
Regarding certificate extensions, the Commission states that the validity of legacy product certificates (not requiring an MDR application) expires on May 26, 2024.
Certificate validity is linked to the risk class, determined by MDR rules for extensions.
In cases where a manufacturer needs to request a derogation under Article 59(1) of the MDR to extend certificate validity, the device benefits from all rights guaranteed by Article 120 until December 31, 2027, or 2028, even if the derogation is time-limited under national law.
An important point of discussion is proving compliance with the requirements for certificate extension. Automatic extension of certificate validity occurs by law, but manufacturers may need to demonstrate compliance with Article 120(3) conditions (MDR).
Proof can be provided through:
- A self-declaration attesting compliance with extension conditions, including the end date of the product’s transitional period.
- A confirmation letter issued by the notified body that issued the certificate, confirming receipt of the application and the conclusion of a written agreement between the parties.
What are the conditions to benefit from the extension?
The Commission clarifies that a complete reassessment by the notified body is not required before signing the written agreement by May 26, 2024. The application should contain only the necessary information to clearly identify the manufacturer, devices, and the information essential for the notified body to conclude the agreement. In principle, this includes:
- Elements listed in the relevant conformity assessment as per Annexes IX to XI of the MDR.
- All information allowing the notified body to verify product qualification as devices, their classification, and the chosen conformity assessment procedure.
- A mutually agreed-upon timeline with the notified body for possible submission of technical documentation and other relevant information.
- Manufacturer’s documentation on the quality management system.
In cases where a manufacturer submits an application for a device intended to replace a previous one, they must identify both the substituting and the replaced devices. Technical documentation for the substituting device can be submitted later.
Surveillance activities by notified bodies
Until September 26, 2024, the notified body according to MDD/AIMDD remains responsible for surveillance of certified medical devices. From the same date, the notified body designated by the manufacturer under MDR assumes responsibility for surveillance.
Therefore, a tripartite agreement between the manufacturer, the notified body according to MDD/AIMDD, and the notified body under MDR is necessary to establish the transfer of surveillance.
This agreement should adhere to the principles of Article 58(1) of the MDR and also govern the transfer of documentation between the two notified bodies. Additionally, the notified body under MDR can suspend or revoke a certificate issued by the notified body under MDD/AIMDD, if adequately justified.
It should be noted that the notified body under MDR does not assume responsibility for conformity assessment activities performed by the notified body under MDD/AIMDD. After the transfer of surveillance, the manufacturer can continue to indicate the number of the notified body under MDD/AIMDD on the labeling unless otherwise specified in the tripartite agreement.
It is important to consider that the implementation of these provisions can be complex as the notified body under MDR becomes responsible for surveillance of devices for which it did not conduct the conformity assessment.
Are you a manufacturer or distributor and unsure about how to submit a certification request under MDR?