Convergence: Experts see hope for meeting EU MDR deadlines

Regulatory NewsRegulatory News | 12 September 2022 |  By 

Left to right: Kevin Butcher, Gert Bos, Sabina Hoekstra-van den Bosch

PHOENIX, AZ – With the European Union’s Medical Device Regulation (MDR) grace period ending in 2024, many medical device companies and consultants are nervous about what that means for their products, especially with limited notified body capacity. While some have fretted about getting new certificates of conformity under MDR in time for the 2024 deadline, experts on a panel on the topic at RAPS Convergence 2022 said there is light at the end of the tunnel.
 
During 12 September session on MDR implementation, Gert Bos, CEO of Qserve and President of RAPS’ Board of Directors; Sabina Hoekstra-van den Bosch, regulatory strategy principal at TUV SUD and a RAPS board member; and Kevin Butcher, principal regulatory consultant at NAMSA; offered hope that sponsors will be able to meet their obligations in time.
 
“The big question is: Can we make changes [to regulations] at this stage?” asked Bos. “I guess that is not feasible. So, if there's going to be some light, it will be interim solutions, it will be not a radical change in our destination.”
 
He emphasized that manufacturers are afraid of the looming deadline because there aren’t enough notified bodies with sufficient capacity to handle the number of products that will need to be reviewed under MDR. He said that he’s seen some notified bodies tell sponsors that if they don’t deliver all their product dossiers by Christmas this year, they won’t be able to keep their product on the market.
 
While sponsors may be able to work faster and more efficiently, he’s also hopeful that the European Commission will treat many of the guidelines it is releasing, such as the MDCG-2014 guideline on notified body capacity, as first drafts and update them over time to accommodate the challenges that device makers face.
 
For their part, Gert said sponsors should have clear communication with their notified body, clear plans and timelines for getting their product to market. He added that they should be selective about their product submissions and should conduct mock audits and dossier reviews. He also said they should avoid potential delays and prepare for worst-case scenarios by stockpiling products and having their derogations in place.
 
Hoekstra-van den Bosch noted that compared to previous device directives, MDR has far more requirements sponsors are expected to meet. However, she said that the European Commission and its Medical Device Coordination Group (MDCG) are empathetic to the challenges sponsors are facing. They are considering how to be flexible in applying the regulations, as evidenced by the fact that the MDCG is encouraging notified bodies to develop a framework for leveraging evidence from previous assessments conducted under the previous directive.
 
“It is a kind of shift in the paradigm because before there was no grandfathering,” said Hoekstra. “So, some things are shifting.”
 
Butcher noted that there’s a lot of confusion from sponsors about MDR and the MDCG guidances. He added that while the MDCG 2022-14 guidance was meant to clarify certain issues, there is still differences of interpretation on several topics, such as the definition of a well-established technology (WET).
 
“It is causing us no end of problems,” said Butcher.
 
While he noted that the MDR doesn’t define what a WET product is, according to MDR Article 61.6(b) only class III or implantable devices may be considered WET devices. On the other hand, the MDCG 2020-6 guidance has tried to define them as products with a simple design, that have well-known safety and performance profiles and significant market history.
 
“The point is, there's no right or wrong answer,” said Butcher. “The problem is manufacturers can't really plan on an evaluation strategy with this level of variance of interpretation because you just don't know. And even with a notified body you'll get different decisions depending on who the reviewer is.”
 
Sharon Goldfarb, a clinical quality regulatory consultant working for startups in Israel, was very pessimistic about what the future hold.
 
“I’m sorry, I don’t see any light at the end of the tunnel,” she said during the Q&A portion of the panel session. “The amount of resources needed to just meet the requirements for these small companies is almost impossible to reach.”
 
She said she’s been advising her clients to leave the European market because the regulatory hurdles seem insurmountable.
 
“The worst part of it is the European people are going to suffer because they’re not going to get access to the technologies coming out,” said Goldfarb. “I don’t think it’s working; I don’t think it’s going to work… I don’t see a future and it frightens me.”
 
Suzanne Halliday, VP regulatory at BSI, is optimistic that things will eventually be hashed out, and noted that there’s a lack of resources and experienced people across the board from the manufacturers themselves, to the notified bodies and the expert panels.
 
“But notice that there are thousands of certificates that have come out, so manufacturers are getting through it,” she said. “We don’t think we are perfect but are encouraging the manufacturers to have a go because we can make a difference and get through some of it before December.”
 
Hoekstra-van den Bosch agreed and noted that it is important for stakeholders to get across to the European Commission about how manufacturers operate on a day-to-day basis and the nuance of how their work may be hampered by the challenges posed by the regulations. She told attendees to keep knocking on the Commission’s door to express their thoughts and propose solutions.

 

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