The European MDR Amendment: What to expect and When?

By Annette Van Raamsdonk

As a representative of the European Association of Authorized Representatives (EAAR), Emergo by UL joined a workshop on the practical implementation of the extension of the Medical Devices Regulation (MDR) transitional period, organized by the European Commission (EC).

The meeting took place March 13, 2023 and the aim was to create a guidance document with frequently asked questions related to the amendment that will extend the MDR transitional period and abandon the “Sell-off” period. All stakeholders had been asked in advance to provide their concerns related to the implementation of the amendment.

The EAAR had amongst others raised concerns on how a manufacturer can demonstrate that its legacy device benefits from the extension of the transitional period, which will be essential for customers and countries that acknowledge the EU regulatory framework, as another key issue pertains to what the meaning is of “a device intended to substitute that device.” These two and 16 other questions have been addressed in a “living” Q&A document that was prepared by the EC and discussed during the March 13 workshop. The document contains five parts (A-E);

• Part A: Scope of the extension of the MDR transitional period
• Part B: Evidence of extended transitional period
• Part C: Conditions to be fulfilled to benefit from the extended MDR transition period
• Part D: Appropriate surveillance to be performed by notified bodies
• Part E: Deletion of the “sell-off” date

The document is expected to be published in mid to late March 2023. The amendment will be officially signed by the European Council and EC March 15^th, and published in the Official Journal of the European Union (OJEU) on March 16^th or 17^th. After publication in the OJEU, the amendment will take effect.

We will keep you updated on the final version of the Q&A document. Note: Although the extension of the transitional provisions gives more time prior to transferring to the MDR, there are certain provisions that need to be met by the manufacturer. Pursuant to Article 120(3c), point (e), MDR, the manufacturer (or the Authorized Representative) must lodge a formal application for conformity assessment no later than May 26, 2024 to benefit from the extended transitional period. Emergo by UL emphasizes the importance of preparing MDR documentation and lodging an application as soon as possible; Notified Bodies are still extremely busy and will remain so even with the aforementioned provision.

Annette van Raamsdonk is vice-chair of the European Association of Authorized Representatives (EAAR), and as such is taking part in several MDCG meetings and EC stakeholder meetings.