Amendment to the MDR and IVDR transitional period is official!

Today, 20 March 2023, the Official Journal of the European Union published the latest amendment to the Medical Devices Regulations (MDR and IVDR). After the Proposal’s adoption and the European Parliament’s vote, the Council of the European Union approved the new transitional period on 7 March 2023.

New transitional period under MDR

The published amendment regards Article 120 of the MDR. Article 120 addresses legacy devices, namely devices subject to the transitional period. Specifically, legacy devices are devices with a Certificate issued under the previous Directives and with a Declaration of Conformity drawn up before 26 May 2021 (MDR application date).

Initially, legacy devices could be placed on the EU market until 26 May, 2024. According to the new transitional provisions, the deadlines are:

• 26 May 2026 for class III implantable custom-made devices, provided the manufacturer has applied for a conformity assessment before 26 May 2024.
• 31 December 2027 for class III and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
• 31 December 2028 for class IIb devices other than those mentioned above, 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).

In addition to the extended transitional period and prolonged certificated validity, the new amendment of IVDR foresees the removal of the ‘sell off’ provision for IVD medical devices. This means that there is no longer an end date from which the devices already on the EU market shall be recalled from the market.

Its important to note that the new MDR deadlines are only applicable provided that the manufacturer complies with the following requirements:

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.

Are you interested in making use of this extension? Do not hesitate to contact us!

You can find all relevant documents in our Library of Documents.