Now that the MDR transition period has been formally extended, the EU Commission released a Q&A document on the ‘practical aspects’: HERE

The document addresses questions such as:

Which devices can benefit from the extended transitional period?

The document clarifies that the extension only applies to legacy devices. This allowance is not applicable to any devices new to the European market, i.e., did not have valid MDD/AIMDD CE Marking on 26 May 2021.

Further, in order for those devices to make use of the 2027-2028 extension, they must meet the additional requirements imposed, which start 26 May 2024 (e.g., implement an MDR compliant quality system).

Is the transition period applicable if a manufacturer does not intend to apply for CE Marking under the MDR?

For a shorter period of time, yes.

If a manufacturer has a CE Marking certificate that expires between 20 March 2023 and 26 May 2024, then they may utilize Regulation 2023/607 to continue marketing during that timeframe. Of course, the manufacturer must continue to comply with the requirements during this time, including related to post-market surveillance, vigilance, etc.

However, after 26 May 2024, the manufacturer must have implemented the requirements, such as having implemented an MDR compliant quality system and lodged a formal application with a Notified Body.

Which classification determines the transition period deadline – the current MDD/AIMDD classification or the new MDR classification?

The MDR classification determines whether the device is eligible for the 31 December 2027 or 31 December 2028 transition deadline, and not the MDD/AIMDD legacy device classification.

The MDD/AIMDD device classification does, however, continue to dictate other types of requirements, such as regarding Periodic Safety Update Report (PSUR) generation and reporting to the Notified Body.

If a certificate has expired before 20 March 2023 and a competent authority has granted a derogation in accordance with Article 59 MDR or has applied Article 97 MDR, how long is the transitional period?

The transition period provided in Regulation 2023/607 supersedes any timeframes granted under Article 59 derogation or Article 97 allowance.

Therefore, if a manufacturer was granted a derogation under Article 59 or authorization under Article 97, and they had signed a written agreement with the Notified Body before 20 March 2023, they are eligible for the full transition period. This is even if the timeframe granted under Article 59 or Article 97 expires well before that date.

How can manufacturers demonstrate that their legacy device is covered under the extension?

While, per MDCG 2020-3, Notified Bodies cannot issue new MDD/AIMDD certificates, they can provide “written confirmation correcting or complementing information on an existing certificate.”

The mechanisms outlined in the Q&A document to “prove” eligibility under the extension are:

• • Manufacturers can generate a self-declaration statement, confirming that the extension requirements per Regulation 2023/607 have been fulfilled. The statement should clearly identify the devices covered by the extension and the CE Certificate(s) to which it applies.
    • The Q&A document mentions that such a statement “could be based on a harmonised statement”. This indicates that the MDCG or other group may release a template that can be utilized for this purpose.
  • The Notified Body could issue a confirmation letter stating the “receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement”. Like the self-declaration, the Notified Body’s confirmation should clearly identify the devices covered by the extension and applicable CE Certificates.
    • The Q&A documents states this could “be issued, in principle, without extra costs.”
  • Manufacturers (or their authorized representatives) could request Certificates of Free Sale and the Competent Authority could issue them noting the extended CE marking validity period.

Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?

Regulation 2023/607 requires manufacturers to put an MDR compliant Quality Management System in place and to have lodged an application with a Notified Body by 26 May 2024.

The Q&A document advises that since the QMS documentation must be drawn up for the conformity assessment application, the lodged Notified Body application acts as a sort of de facto verification that this requirement has been fulfilled.

Other questions

The document addresses additional questions, such as:

• • What are the necessary elements of a formal application lodged by the manufacturer?
  • What are the necessary elements of a written agreement between the manufacturer and the notified body?
  • What is the meaning of “device intended to substitute that device”?
  • What are the necessary elements of the arrangement for the transfer of the surveillance from the notified body that issued the MDD/AIMDD certificate to the MDR notified body?

We recommend reading through the entire document to understand your requirements under the MDR transition period extension.

Also watch for Casus to issue a new ‘living’ Resource page on the MDR transition, which will be updated as information is released or revised. It will be an easy-to-read format and outline all key dates.