Voting Complete – extension of MDR transition times and removal of sell-off period for devices from MDR and IVDR

The EU Parliament has adopted the MDR amendment proposal, February 16th, and removed the sell-off date for both medical devices and in-vitro medical devices. The amendment will come in force upon publication in the official journal, which is expected in the coming weeks.

The European Parliament has on February 16th adopted the Commission proposal for bridging measures for certificates that expire pending MDR conformity assessment. The transitional provisions extends the transition time for certain medical devices under MDR 2017/745 Article 120(3) by risk class as following:

  • 31 December 2027 – all 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 other than above, class IIa devices, and class I devices placed on the market sterile, or having a measuring function, or are reusable surgical instrument;
  • 26 May 2026 – for class III custom-made implantable devices.

The extension of transition time is combined with an extension of validity of certificates issued under MDD by amending MDR Article 120(2).

Conditions for extension:

  • the devices continue to comply with the directives (MDD, AIMDD);
  • devices have not undergone significant changes in design or intended purpose;
  • the devices do not present an unacceptable risk to health or safety of patients, users, other persons, or other aspects of the protection of public health;
  • the manufacturer has put in place a quality management system according to MDR no later than 26 May 2024;
  • the manufacturer has lodged a formal application with a notified body no later than 26 May 2024, and have signed a written agreement no later than 26 September 2024.

Also, the sell-off date in Article 120(4) of MDR 2017/745 and the corresponding Article 110(4) of IVDR 2017/746 has been removed, enabling distribution of legacy products until stock is empty.

 

The 7th EAAR Annual Conference on the New Medical Device Regulations

Welcome 2-3 February in Brussels, Belgium to listen to Robert Ginsberg, Nils-Åke Lindberg and many other experienced speakers in the panel.

Read more about the speakers here.

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Proposed changes of MDR transition times

EU Commission is proposing elements of a bridging measure for MDD certificates that expire pending MDR conformity assessment

A Commission proposal for bridging measures for certificates that expire pending MDR conformity assessment was on the agenda for the EPSCO meeting on December 9, 2022. The proposal suggests an extension of the transition time for legacy devices under MDR 2017/745 Article 120(3) by risk class to the year (dates not specified yet):

  • 2027 – Class III
  • 2027 – Class IIb
  • 2028 – Class IIa
  • 2028 – Class I devices that need involvement of a Notified Body in the conformity assessment

The extension of transition time could possibly be combined with an extension of validity of certificates issued under MDD by amending MDR Article 120(2).

Conditions for extension:

  • devices must not present any unacceptable risk to health and safety;
  • devices have not undergone significant changes in design or intended purpose;
  • manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a deadline still to be proposed.

Also, it was proposed to remove the “sell-off” provision in Article 120(4) and the corresponding Article 110(4) of IVDR 2017/746 enabling distribution of legacy products until stock is empty.

Although no concrete dates have yet been revealed, a new position paper has been published in the form of MDCG 2022-18 right after the EPSCO meeting. According to this position paper, if certification of devices under the MDR has not been finalized before expiry of the Directive’s certificate, and if the device does not present an unacceptable risk to health and safety, Article 97 of MDR enables Competent Authorities to require the relevant manufacturer, or its authorized representative, to bring the non-compliance to an end within a reasonable and clearly defined period. This might limit the impact of NB resource insufficiencies on the supply of safe and effective devices to patients and healthcare providers.