Legacy devices: European Commission adopts proposal to extend Transitional period & Certificates!

The European Commission has adopted a new proposal to give more time to certify medical devices, which affects legacy devices under Article 120.3 of the Medical Devices Regulation (MDR) 2017/745. This proposal comes after the EPSCO meeting discussions on the extension period for legacy devices we covered in a previous post. Therefore, among the main points of the proposal, we can find the following:

• The transition period extension depends on the device’s risk and type. Therefore, medical devices covered by a certificate or/and a declaration of conformity issued before 26 May 2021 will have the following periods: 
  • Until 31 December 2027 for higher risk devices
    
    • Class III devices and Class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
  • Until 31 December 2028 for medium and lower risk devices
    • Class IIb devices other than those covered by above point, Class IIa devices, Class I devices placed on the market in sterile condition or having a measuring function, Class I devices that will need to involve a notified body for the MDR conformity assessment (up-classified devices)
      

The extension will be subject to the conditions that:

1. 1. Devices do not present an unacceptable risk to the health or safety of patients;
      
   2. No significant changes in the design and intended purpose of the devices;
   3. Manufacturer has set up an MDR complaint QMS by 26 May 2024 (Article 10.9 MDR);
   4. Manufacturer is compliant with MDD and the legacy requirements set in the MDR;
   5. Manufacturer or his AR has applied to a notified body for a conformity assessment under the MDR – by the latest 26 May 2024;
      
   6. Manufacturer and notified body have signed a written agreement – by the latest 26 September 2024.
      

Moreover:

• Class III implantable custom-made devices will have a transition period until 26 May 2026, provided the manufacturer has applied for a conformity assessment before 26 May 2024;
• The extension of the transition periods also means the extension of the validity dates of certificates issued up until 26 May 2021 to 31 December 2027 or 31 December 2028 – depending on the risk class above;
• Finally, this proposal aims for the removal of the “sell-off” provisions set in the MDR and IVDR that was originally envisaged to require manufacturers to withdraw non-Regulation complaint devices at a specific date.
  

What about Certificates that expired already?

In case a Certificate expired before the new Regulation has been published (on the basis of the European Commission proposal amending the MDR), but the Certificate was valid on May 26, 2021, the following two conditions apply to manufacturers:

• Need for a written agreement signed between the manufacturer and the notified body (NB) before the Certificate expired OR
• Receive a derogation (”authorisation”) from a Competent Authority by following either Art. 59 or Art. 97 MDR (while transitioning to MDR certification)

The reason for this extension is to guarantee the supply of medical devices to the EU market and to mitigate the risk of shortages. Please note that this is a European Commission’s proposal, and it would need to be adopted by the Council of the European Union and the European Parliament to come into application as part of the EU’s legislative process.

You can find all Commission and other relevant documents in our Library of Documents