Manufacturers of certain lower-risk medical devices could soon get some breathing room to comply with the incoming EU Medical Device Regulation (MDR), which takes effect May 26, 2020, but a compliance delay for certain low-risk devices is far from certain.
That's because the European Commission (EC) initiated a corrigendum in May to amend or modify some parts of the regulation. The corrigendum would potentially give some Class I devices — including certain reusable products like surgical instruments and endoscopes — a four-year transitional period before they are required to meet the new regulation's standards.
The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday to discuss the state of play. The corrigendum "is on the way," Manfred Beeres, director of communication and media relations at BVMed, the German Medical Technology Association, told MedTech Dive.
"The key issue is a transitional period that will be introduced for class l devices that are classified higher by the MDR," Beeres wrote Monday. "In this way, the 'hard deadline' in May 2020 could be avoided."
The EC initiated the draft in the spring, all member states agreed to it, and now the European Parliament has to pass the corrigendum, he said. Beeres expects a vote to happen this month.
The move to pass the corrigendum is significant because Class I devices make up 40% of all medical devices, Beeres said. If approved, it will give manufacturers of certain upclassified Class I devices four more years to find a notified body (NB), which are responsible for certifying medical products under the new regulation, and fulfill compliance requirements.
Under the older EU Medical Device Directive, products regulated as Class I devices did not require NB review. The industry has been scrambling to comply ahead of the 2020 deadline but has been frequently stymied due to capacity issues related to NBs.
Still, the extension isn't a done deal.
"We were told that the changes will be mostly technical," Françoise Schlemmer, director of Team-NB, told MedTech Dive in an email. Team-NB is the European Association of Notified Bodies active in the medical device sector.
Although Schlemmer noted there is pressure to allow Class I 'upclassified' products to benefit from the grace period until 2024, "It is far from being done," she said.
"This will need agreement from both the Commission and the member states," Schlemmer said.
Schlemmer expects the corrigendum in November, a bit later than Beeres' estimate.
"It needs to go through the legal services of the Commission after agreement among the stakeholders," she said. It also will need to be discussed among the Council of the European Union.
Meanwhile, the pace of designating notified bodies under the MDR has been sluggish at best. In June, Vytenis Andriukaitis, the European Commissioner for Health and Food Safety, told members of the Employment, Social Policy, Health and Consumer Affairs Council he expected around 20 notified bodies to be designated before the end of 2019.
To date, only five NBs have received that status under the MDR. They are Italy's IMQ, Germany's Dekra, TÜV Rheinland and TÜV SÜD, as well as the United Kingdom's BSI.
"The biggest bottleneck is notified bodies," Rebecca James, a manager with KPMG's healthcare and life sciences practice, said. "It's difficult from their business model perspective for them to onboard a lot of people to do the work because they're not even designated to do the work yet."
And the workload facing NBs is starting to pile up, James added. "They've got clients coming to them and asking for help getting started and they don't have the resources to be doing all that yet."
