Posted 27 October 2020 | By
Companies are failing to make optimal use of the Medical Device Regulation (MDR) grace period for compliance, adding to the problems created by capacity constraints and tight deadlines, according to experts who spoke at the Euro Convergence 2020 virtual meeting.
In November last year, the European Commission issued a corrigendum to the MDR, allowing manufacturers of certain class I products an additional four years, to 26 May 2024, to comply with the regulation. Under the extended the grace period, manufacturers can continue supplying class I products certified under the Medical Devices Directive (MDD).
[RELATED: Second MDR corrigendum targets class I devices, Regulatory Focus, 26 November 2019.]
Much has happened since then, including the April delay of the MDR date of application to 26 May 2021, which effectively shortened the grace period by a year. In addition, residual problems – such as too few notified bodies and too little time – have persisted.
“It is not what everyone [was] hoping for,” said Gert Bos, FRAPS, CTO, executive director and partner at Qserve Group. A longer grace period would have been preferable, because the shortened grace period has reduced the time available for bridging the “gap between MDD and MDR.”
The problems created by the truncated grace period are being exacerbated by the inefficient some companies are using the time. Erik Vollebregt, a founding partner at Axon Lawyers, said he has seen “quite a lot of suboptimal use of the grace period.” He discussed several common mistakes companies are making in their use of this time.
For example, Vollebregt said he has seen some US companies reassign 80% of their MDR transition teams to other roles because they had expected the rules to come into effect in May 2020. When the date of application was delayed because of the pandemic, the companies stayed with their original plans, despite the continued need for staff to continue working on MDR.
Other companies have yet to fully grasp the implications of the changes, said Vollebregt, so their regulatory and commercial plans will likely need significant adjustments when they do come up to speed.
Vollebregt also sees a tendency for companies to renew MDD certificates, which allows them to benefit from the grace period, and then relax in the belief they have bought themselves several years of preparation time. Failing to maintain the pace of preparations could cause trouble for companies down the line, he warned.
“The more work that has piled up by the end of the grace period, the more [notified bodies] will have to say ‘no’ because they'll be completely fully booked,” Vollebregt said.
Sabina Hoekstra-van den Bosch, PharmD, FRAPS, regulatory strategy principal at TUV SUD, agreed with Vollebregt about the build-up to a bottleneck. “We see the work piling up,” she said.
Notified bodies have had to be flexible to continue serving customers in the changing environment, for example, by reactivating MDD activities when the MDR date of application, which they had spent years gearing up for, was extended. But however notified bodies juggle their resources, they will still have to face the reality that demand is exceeding supply.
There is a small pool of experts with the knowledge and experience needed in new hires at notified bodies. That limits their ability to boost capacity, and the continued need to conduct on-site audits amid the pandemic is holding up work from getting done. The designation of more notified bodies could provide some relief, but a recent pipeline update suggests a significant increase is unlikely in the near term.
Those pressures are shaping Hoekstra-van den Bosch’s views on what needs to be done next. Asked what additional high-level decision she would like the European Commission to make, she said: “It will not surprise you. Remote audits, combined with a ... shorter designation process.”
Euro Convergence 2020
In November last year, the European Commission issued a corrigendum to the MDR, allowing manufacturers of certain class I products an additional four years, to 26 May 2024, to comply with the regulation. Under the extended the grace period, manufacturers can continue supplying class I products certified under the Medical Devices Directive (MDD).
[RELATED: Second MDR corrigendum targets class I devices, Regulatory Focus, 26 November 2019.]
Much has happened since then, including the April delay of the MDR date of application to 26 May 2021, which effectively shortened the grace period by a year. In addition, residual problems – such as too few notified bodies and too little time – have persisted.
“It is not what everyone [was] hoping for,” said Gert Bos, FRAPS, CTO, executive director and partner at Qserve Group. A longer grace period would have been preferable, because the shortened grace period has reduced the time available for bridging the “gap between MDD and MDR.”
The problems created by the truncated grace period are being exacerbated by the inefficient some companies are using the time. Erik Vollebregt, a founding partner at Axon Lawyers, said he has seen “quite a lot of suboptimal use of the grace period.” He discussed several common mistakes companies are making in their use of this time.
For example, Vollebregt said he has seen some US companies reassign 80% of their MDR transition teams to other roles because they had expected the rules to come into effect in May 2020. When the date of application was delayed because of the pandemic, the companies stayed with their original plans, despite the continued need for staff to continue working on MDR.
Other companies have yet to fully grasp the implications of the changes, said Vollebregt, so their regulatory and commercial plans will likely need significant adjustments when they do come up to speed.
Vollebregt also sees a tendency for companies to renew MDD certificates, which allows them to benefit from the grace period, and then relax in the belief they have bought themselves several years of preparation time. Failing to maintain the pace of preparations could cause trouble for companies down the line, he warned.
“The more work that has piled up by the end of the grace period, the more [notified bodies] will have to say ‘no’ because they'll be completely fully booked,” Vollebregt said.
Sabina Hoekstra-van den Bosch, PharmD, FRAPS, regulatory strategy principal at TUV SUD, agreed with Vollebregt about the build-up to a bottleneck. “We see the work piling up,” she said.
Notified bodies have had to be flexible to continue serving customers in the changing environment, for example, by reactivating MDD activities when the MDR date of application, which they had spent years gearing up for, was extended. But however notified bodies juggle their resources, they will still have to face the reality that demand is exceeding supply.
There is a small pool of experts with the knowledge and experience needed in new hires at notified bodies. That limits their ability to boost capacity, and the continued need to conduct on-site audits amid the pandemic is holding up work from getting done. The designation of more notified bodies could provide some relief, but a recent pipeline update suggests a significant increase is unlikely in the near term.
Those pressures are shaping Hoekstra-van den Bosch’s views on what needs to be done next. Asked what additional high-level decision she would like the European Commission to make, she said: “It will not surprise you. Remote audits, combined with a ... shorter designation process.”
Euro Convergence 2020
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