Today EU Parliament voted in favor to amend the MDR Article 120 transition provisions, in its first reading. The text on adoption of the extension is available: HERE

Per the adoption text “The European Parliament ….

1. 1. Adopts its position at the first reading hereinafter set out;
   2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amends or intends to substantially amend its proposal;
   3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.”

Due to the urgency of the situation:

 “…this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union.

For the same reasons, it is also considered to be appropriate to invoke the exception to the eight-week period provided for in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union…”

What are the next steps?

If there are any further changes proposed by the EU Council, it goes back to EU Parliament. However, if no changes are made, the amendment will be published in the Official Journal of the European Union (OJEU), which will then be the ‘entry into force’ date.

What amendments were approved for adoption?

The amendments start on page 11 of the document, and include:

• • MDD/AIMDD Notified Body issued Certificates that were valid on 21 May 2021 and have not been withdrawn afterwards, shall remain valid after the end date indicated on the certificate, until the following dates:
    • 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 all other Class IIb, Class IIa and Class I sterile/measuring devices
  • MDD Class I self-certified devices with a Declaration of Conformity drawn up prior to 26 May 2021, and which were up-classed under the MDR, are granted a further extension until:
    • 31 December 2028
  • Class III custom-made devices will be granted a further transition period, until:
    • 26 May 2026
  • Devices lawfully placed onto the market prior to the extension cutoff dates, may continue to be made available on the market or put into service, i.e., removal of the sell-off date provision
    • This removal of the sell-off date is also granted for IVDs

Certain conditions apply for the above, which are outlined in the text document. Casus will provide a more in-depth overview of the new deadlines and transition period requirements shortly.