European Commission published the official text of the proposal to extend the MDR transition period for legacy devices on 6 January 2023. The amendment has been formally adopted by both the European Parliament and the Council on 15 March 2023.On 20 March 2023,it has been published in the Official Journal and entered into force.
As expected, the extension is staggered depending on the risk class of the medical device. The following dates is applicable for manufacturers who have signed a contract with a notified body for MDR certification until 26 May 2024. The additional requirements are to maintain the validity of CE certificates issued under Regulation 90/385/EEC or 93/42/EEC in accordance with Article 120(2) and to bring the quality management systems into compliance with the MDR,
– Class III and IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors; until 31 December 2027
– Class IIb, Class IIa and Class I devices until 31 December 2028
In addition, Class III implantable custom-made devices is also able to be placed on the market until 26 May 2026, provided that a contract for quality management system certification under Annex IX is signed by 26 May 2024.
Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.
This amendment has been approved by the EU Parliament and the Council and covers only “legacy devices”. New devices and devices undergoing significant changes in design and intended use must be certified according to the MDR as before.
This amendment gives manufacturers and notified bodies more time to carry out conformity assessment procedures in accordance with the MDR if these conditions are met.
It also removes the “sell-off” provision in Article 120(4) MDR and Article 110(4) IVDR. This will avoid unnecessary disposal of safe medical devices that are already on the market but not yet in the end user.
If a MDD or AIMD certificate expired before the approval date of the amendment, the manufacturers are able to allowed to continue to place their device on the market till the date mentioned above, provided that;
- before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
- competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) or has required the manufacturer, in accordance with Article 97(1), to carry out the applicable conformity assessment procedure
The amendment also allows extension until 31 December 2028 of transition for up classified class I medical devices.
You can reach the full test of the amendment of the regulation from this link:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0607&from=EN