Council votes unanimously to extend MDR deadlines

The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
 
On 7 March, the Council voted 27-0 to adopt the measure put forward by the European Parliament and Commission. The parliament voted 537-3 on 16 February to push back the MDR transition period to avoid potentially forcing tens of thousands of products off the market in the economic region. (RELATED: European Parliament votes to extend MDR transition period, Regulatory Focus, 16 February 2023)
 
“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” Acko Ankarberg Johansson, Swedish minister for health care, said in a press release.
 
The measure had already been approved by the European Commission on 6 January. With the looming MDR transition deadlines coming up in the next few years, stakeholders have raised concerns about the supply of medical devices, notified body capacity and manufacturer preparedness, which prompted the move to extend the transition period. (RELATED: European Commission moves to delay MDR transition, 6 January 2023)
 
The measure will next be published in the Official Journal of the European Union, at which point it will go into immediate effect. It would extend the transition deadline for Class III and IIB implantable devices to December 2027; Class IIB non-implantable devices, and Class IIA and Class I devices would need to transition by December 2028; Class III custom-made implantable devices would need to transition by May 2026; and the sell-off requirements for products under MDR and IVDR will no longer apply.
 
Gert Bos, executive director of the Qserve Group, cautioned medical device manufacturers that even with the MDR deadline extensions, there’s no time to waste and they should be working diligently to finalize their dossiers to notified bodies (NB) and ensure they have enough clinical data to prove their product works as intended.
 
“The intention of the extension is to allow sufficient time for the notified bodies to use their scarce resources to complete all needed conformity assessments,” he told Focus. “It is not intended to give much time for industry, as their dossiers should be ready for review in about a year’s time in order to get a signed agreement for the work from the notified body they work with.”
 
Sabina Hoekstra-van den Bosch, vice-president of Team-NB and global director of regulatory strategy at TÜV SÜD, noted that the Medical Device Coordination Group (MDCG) has proposed several measures in their MDCG 2022-14 position paper that allow notified bodies to use their available capacity more efficiently. She said she is worriee that those measures may be pushed into the background as all the attention is focused on legislative changes.
 
“To allow extension of the transition timelines to be successful, it is still necessary that some proposed measures of MDCG 2022-14 be put into action, if this has not happened yet,” Hoekstra-van den Bosch told Focus. “Proposals from 2022-14 that could contribute to the success of the amending regulation are for instance: allowing structured dialogue between manufacturers and notified bodies, leveraging evidence that notified bodies have already assessed under the Directives and where there is no change in the MDR as compared to the Directives, review of existing MDCG guidance and amending/removing unclarities and/or other provisions that could be improved and giving clarity to manufacturers and notified bodies on when a new MDCG guidance document will become applicable.”
 
The news was not just a sigh of relief for stakeholders in Europe. Across the pond, the medical device lobby group AdvaMed also commended the EC’s decision to adopt the measure.
 
“Today’s vote by the EU Council gives the medtech industry the opportunity to continue saving and improving the lives of patients in Europe. The EU is one of the world’s preeminent markets for quality patient care, R&D, and access, serving millions of patients annually, so it’s critical that MDR implementation is done correctly,” said AdvaMed CEO Scott Whitaker in a press release. “Together with MedTech Europe, we’re working to fully address several remaining issues, including a clearer process for submitting applications to notified bodies, as well as greater clarity on how certificate extensions can be demonstrated.”
 
“We are also working to address practical implementation issues, such as access to ‘orphan’ and niche devices in the EU market,” he added. “This is a strong step forward for patients worldwide, and AdvaMed will continue to champion a robust EU regulatory scheme that fosters innovation and patient access to treatment in a timely and predictable manner."
 
Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.