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EU set to delay medical device regulations

European manufacturers of medical devices are set to get more time to prepare for forthcoming regulatory changes, after the European Commission adopted a proposal to delay the changes.

According to a recent announcement from the Commission, the proposal will now be sent to the EU’s parliament and council, where final approval is set to arrive through an 'accelerated co-decision procedure'. The delay was proposed last month by Stella Kyriakides, the EU’s health commissioner, as complaints mounted about stricter regulations and the high costs and long waits to comply with them.

The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices' risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (ie, no ‘sell-off' date).

The Commission’s statement said: “The availability of safe medical devices for European patients is our priority. This proposal does not change any of the current safety and performance requirements provided for in the Medical Devices Regulation. It only amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation. The length of the proposed extension of the transition periods depends on the type of device: higher risk devices such as pacemakers and hip implants will benefit from a shorter transition period (until December 2027) than medium and lower risk ones, such as syringes or reusable surgical instruments (until December 2028).

 

Key elements of the proposal:

  • For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
  • The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
  • To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
  • The Commission also proposes to remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need. 

 

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Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

Sheffield Hallam University, City Campus, Howard Street, Sheffield
24th May 2024

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