European Commission moves to delay MDR transition

Regulatory NewsRegulatory News | 06 January 2023 |  By 

This article has been corrected to clarify information related to proposed removal of the sell-off date provisions.

The European Commission on Friday adopted a proposal to allow medical device makers more time to certify their products under the EU Medical Devices Regulation (MDR) amid concerns that the regulation could prompt shortages of lifesaving products. The proposal would also repeal the “sell-off” date provision under both MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
 
“Despite important progress made in the implementation of the Regulation, the overall capacity of notified bodies remains limited for ensuring a successful transition to the new regulatory framework,” the Commission said. “In addition, many manufacturers are not sufficiently prepared to meet the robust requirements of the Medical Devices Regulation by the end of the current transition period. This threatens the availability of medical devices on the EU market.”
 
Under the proposal, the transition period deadline is extended from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device. High-risk devices would be subject to the shorter transition period ending in 2027, while low- and medium-risk devices would have until the end of 2028 to complete a conformity assessment.
 
For class III custom-made implantable devices, the Commission is proposing to create a new transition period until 26 May 2026, to give manufacturers more time to get their quality management systems certified by a notified body. For such manufacturers, the new transition period will only apply if the firm has applied to a notified body by 26 May 2024 and has signed a contract for the certification by 26 September 2024.
 
Regarding the deletion of the sell-off date provision, the Commission said the measure will reduce the risk of shortages by allowing devices and IVDs that were already on the market based on compliance with the former directives to remain on the market. The Commission noted that the provision would not allow devices with a limited shelf-life to be offered past expiry.
 
The Commission said that extending the transition period would not compromise patient safety. “The application of the extended transition periods will be subject to several cumulative conditions, in order to ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the Medical Devices Regulation will benefit from the additional time,” the Commission said, pointing to the COVID-19 pandemic, supply chain disruptions, notified body capacity and economic operator preparedness as factors necessitating the delay.
 
The proposal comes one month after members of the European Council expressed support for delaying the MDR transition period. In a meeting before the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels on 9 December, European Health Commissioner Stella Kyriakides recommended the delay given the multiple issues putting a “strain on market readiness.”
 
“A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients. Today, we propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages and safeguarding access for patients most in need. I call on the European Parliament and the Council to quickly adopt the proposal. Member States and notified bodies should also work with industry to ensure transition to the new rules provided for by the Medical Devices Regulation, without further delay,” Kyriakides said in a press release on Friday.
 
The proposal will now be sent to the European Parliament and Council under an accelerated co-decision procedure to get final approval from legislators for the new deadlines.
 
Press release, Q&A

 

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