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MDR's Day One: Experts weigh in

Posted 26 May 2021 | By Kari Oakes 

MDR's Day One: Experts weigh in

Editor’s note: Today, MDR comes into effect. We took the opportunity to check in with medical device regulatory experts now that the day is at hand. This “News in Focus” article is the first in an occasional series where we will provide expert perspective or opinion on regulatory news. Look to Regulatory Focus for more insights on other topics in the coming weeks.
 
In the EU, the day has come. On Wednesday, the European Commission applied the updated suite of regulations known as the Medical Devices Regulation (MDR). The 26 May 2021 date comes a year later than the originally planned date of application of new regulations for EU’s medical devices industry, to work around disruptions caused by the COVID-19 pandemic.
 
The European Commission (EC) issued a question-and-answer document Wednesday announcing the application of MDR; the document notes that some MDR provisions will not be in place until 2025, to smooth the transition. The document itemizes the many patient benefits EC sees stemming from modernized medical device oversight; it also delineates which products fall under the new regulation, and outlines some of the updates.  
 
“The new rules improve the safety and quality of medical devices while providing more transparency for patients and less administrative burden for businesses,” said Stella Kyriakides, the EC Commissioner for Health and Food Safety, in a statement. “The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges.”
 
Are device manufacturers and notified bodies ready for MDR’s Day One? Sabina Hoekstra-van den Bosch, PharmD, FRAPS, regulatory strategy principal at TÜV SÜD, gave a qualified “yes” in an interview with Focus. “The notified bodies that have finished the designation process are definitely ready,” she said, noting that the pace of designation has been running more than a year behind EC’s estimates when it sketched out its timeline.
 
Erik Vollebregt, LLM, a partner at Amsterdam-based Axon Lawyers, had a more guarded assessment.  "We are now as far in the rollout process with notified body capacity, guidance, and so forth as we would have wanted to be on the date of entry into force, four years ago,” he said. “In that case everyone would have had a transitional period that would have been meaningful.”
 
Gert Bos, PhD, FRAPS, Executive Director and partner at the Netherlands’ Qserve Group EU, said that device manufacturers are in better shape than in vitro diagnostic (IVD) firms, but that backlogs are still a significant issue for MDR-related work. “Notified bodies in most cases cannot do the audits, and resourcing to do assessments is restricted,” noted Bos.
 
“But the key worry,” said Bos, “appears to be that only a limited fraction of current products on the EU market are actually being assessed for MDR at this stage, as conformity assessment applications to the 20 notified bodies that are currently designated are quite low in numbers.”
 
Hoekstra-van den Bosch said that notified bodies do have the “technical knowledge and expertise to work around” some of the significant knowledge gaps that remain as MDR rolls out. However, she added, “This is not the most efficient utilization of the current notified body capacity." Each time a published guidance means that processes must change, notified bodies “need time, effort and resources to adjust their work processes and train their staff.”
 
When asked about pain points, Hoekstra-van den Bosch pointed to ongoing pandemic-related problems and a lack of coordination among member states. “Manufacturers and notified bodies cannot finish their MDR projects, because MDR requires on-site audits,” said Hoekstra-van den Bosch. “The Commission notice of January 2021 has put the ball in the member states’ court and until now we’ve not seen a harmonized approach across Europe.”
 
“In addition, when the pandemic broke loose in Europe in March 2020, it was estimated that it would end much sooner than it actually will,” said Hoekstra-van den Bosch. “We are now in May 2021, 14 months later, and it is still not resolved.”
 
Another downstream issue identified by both Hoekstra-van den Bosch and Bos is the wave of MDR applications coming in 2023 and 2024, when MDD certificates grandfathered under the grace period must transition. “That volume will be insurmountable,” said Bos.
 
Hoekstra-van den Bosch identified contributors to the coming onslaught: “The one-year postponement of the MDR date of application, in combination with the fact that MDR projects could not be finished because it was not possible to do audits remotely, resulted in massive renewals of MDD certificates” in 2020, she said.
 
“Under the current circumstances many of the important questions still need to be answered,” said Vollebregt. “But we will work with the MDR, because it's there and the best we've got.”
 
In Bos’ assessment, there’s a sense of relief and renewed commitment now that the new order is finally here; he’s seen renewed energy among colleagues and clients through the spring. “Many are slowly getting used to our new ways of working," he said. “Chin up, and get to the work at hand!”

 

© 2021 Regulatory Affairs Professionals Society.

Tags: devices, EC, EU, MDR, medical

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