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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

MDR/IVDR Implementation – the European Commission’s Proposal of 6 January 2023

https://health.ec.europa.eu/latest-updates/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en

It should be noted that only those manufacturers shall benefit from the additional time granted who have taken steps to transition towards compliance with the MDR and therefore meet the following conditions:

  • devices continue to comply with the MDD and AIMDD, as applicable;
  • there are not significant changes in the design and intended purpose;
  • the devices do not present an unacceptable risk to the health and safety of patients, users or other persons, or to other aspects of the protection of public health;
  • no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Art. 10(9) MDR; and
  • no later than 26 May 2024, the manufacturer has lodged a formal application for conformity assessment for the device in question, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement for such conformity assessment.

The Proposal then also removes the so-called “sell-off” dates (new Art. 120 (4) MDR and Art. 110 (4) IVDR) which allows safe medical devices and in vitro devices already placed on the market to remain on the market without restriction to prevent unnecessary disposal of and adding to further shortages of devices provided that devices were in compliance with previous legal requirements under the applicable EU directives. Due to the exceptional circumstances to prevent a public health crisis and to ensure continued and immediate access to life-saving medical devices, the Proposal will be adopted by the European Parliament and the Council through an accelerated co-decision procedure with an exception to the standard eight-week period that shall elapse between a draft legislative act being made available to national parliaments in the official languages of the Union and the date when it is placed on a provisional agenda for the Council for its adoption. There is no formal time limit for the Parliament and Council’s first reading, but we expect that these legislative bodies will adopt quickly given the accelerated co-decision procedure and the unified support from the European Parliament, Member States and stakeholders (healthcare professionals, patients, academia, scientific bodies, industry and notified bodies) for urgent adoption. The initiative is to be seen in the context of ongoing discussions and interactions primarily in the framework of the Medical Device Coordination Group (MDCG) dedicated to notified capacity and readiness issues concerning the MDR and IVDR implementation.

https://www.eucope.org/mdr-ivdr-implementation-the-european-commissions-proposal-of-6-january-2023/

 

MDR and IVDR outlook for 2023

https://medicaldeviceslegal.com/2023/01/01/mdr-and-ivdr-outlook-for-2023/

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