The long awaited second corrigendum (MDR COR 2)
- english Version of the COR 2
- German Version of the COR 2
- other languages Version of the COR 2
is now finally "deemed to be approved" by the EU-Parliament as there was no further request on voting on the ENVI Document during the meeting held on December 16th in Straßburg.
It was handled as TOP 6 of that meeting and results with the following statement in the protocol:
6. Corrigenda (Rule 241)
The ENVI and INTA Committees had forwarded the following corrigenda to texts adopted by Parliament:
— Corrigendum P8_TA(2017)0107(COR02) to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1) (position of the European Parliament adopted at second reading on 5 April 2017 with a view to the adoption of the above regulation P8_TA(2017)0107)(10728/4/2016 – C8-0104/2017 – 2012/0266(COD)) - ENVI Committee;
In accordance with Rule 241( 4), these corrigenda would be deemed approved unless, within 24 hours, a request was made by a political group or Members reaching at least the low threshold that they be put to the vote.
The major change introduced with this corrigendum the transition period for all class I devices that were placed onto the market under the MDD without envolvement of a notified body and that
require the conformityassessmentsperformed by a notified body under the MDR will be prolonged until 26.May 2024 unless there is a significant change to the device.
The COR 2 will lead to a new wording of Art. 120(3):
By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues (...)'.
In addition some minor changes were introduced...