Self-Care Medical Devices Sitting In The ‘Danger Zone,’ AESGP Warns
Executive Summary
The Association of the European Self-Medication Industry (AESGP) warns that many self-care medical devices could fall through the cracks of implementing new EU regulations, as the deadline draws near.
The challenge of implementing the European Union’s (EU’s) new Medical Device Regulation (MDR) poses a threat to the future viability of the region’s self-care medical devices market, the Association of the European Self-Medication Industry (AESGP) has warned.
Speaking at AESGP’s recent Regulatory Conference in Amsterdam, the association’s deputy director general, Maud Perrudin, told delegates that substance-based, self-care devices were currently in the “danger zone” of missing the certification deadline as the difficulties of implementing MDR on time stacked up.
While AESGP had “many concerns” with how MDR would be implemented, substance-based devices were its primary focus, Perrudin insisted, as these products were “not so well known” to EU regulators implementing MDR or to the notified bodies tasked with re-certifying such devices before the 26 May 2020 cut-off date.
According to the new rules, many self-care medical devices need to be re-certified before 26 May, otherwise they will no longer be allowed to be marketed within the EU.
Many self-care devices are currently considered Class I medical devices, the lowest risk category within the MDR, not requiring a certification by a notified body.
However, the re-classification of substance-based devices, which will fall into Class IIa, IIb or III, depending on their “intended purpose” within the body, place a higher burden on regulators and notified bodies due to their more complex evidence requirements. Therefore, these devices are at greater risk of falling through the cracks during the implementation process.
“The clock is ticking,” Perrudin warned fellow panelists, which included key figures in the MDR implementation process, such as chair of the executive group of the Competent Authorities for Medical Devices (CAMD), Helena Dzojic, head of European Medicines Agency (EMA’s) Human Medicines Evaluation Division, as well as the director of the European Association of Medical Devices Notified Bodies (Team-NB), Françoise Schlemmer.
“We are just really anxious to see whether we will have, sooner rather than later, designated notified bodies that have the confidence to review our substances-based products and certify them on time,” Perrudin said.
More Notified Bodies Needed
“To move on this, we need more notified bodies,” Perrudin suggested.
Perrudin pointed to the presentation by Team-NB’s Schlemmer, which attempted to reassure delegates that capacity for implementing the MDR was being built by the notified bodies-side of the med-tech industry.
Team-NB, which currently represented 24 notified bodies in Europe, had formed several working groups to analyse the implications of MDR, Schlemmer said, and help its members successfully apply for designation.
According to a survey conducted in December, Schlemmer noted that many of Team-NB’s members had submitted applications for MDR designation and were at various stages of the process.
“One is now designated in the European Commission’s (EC’s) New Approach Notified and Designated Organisations (NANDO) Information System,” Schlemmer revealed, while another was in the final stages of the designation process. Eleven more members were currently applying, she added, and a few more would be engaging in the process later this year.
Capacity was a “hot topic,” Schlemmer admitted, but she insisted notified bodies were taking this “very seriously.”
“Every time I’ve asked members about this over the last two years, they’ve said that their capacity was increasing and that they were intending to hire more staff in the next months and years.”
However, Oliver Bisazza, director of Regulations & Industrial Policy for MedTech Europe, was not reassured by Schlemmer’s insistence that notified bodies would be ready for MDR implementation in 2020.
Notified bodies that were “more overworked and overloaded” than ever before, and dealing with new requirements and expectations, was of “great concern” to the med-tech industry, he said.
“What that means is a system that is stretched to capacity,” Bisazza warned. “You can very easily imagine that in a situation like that some lucky manufacturers get through and get their products certified by a designated notified body, while others are left with nowhere to go.”
Furthermore, the only notified body to be designated so far was based in the UK, he pointed out.
At this stage, it isn’t clear what will happen to CE-marked medical devices certified in the UK after Brexit, especially if no withdrawal agreement is negotiated between the UK and the EU.
Not only were contingencies relating to post-Brexit certification and regulation “long overdue,” Bisazza wondered whether the regulatory system as a whole needed to implement MDR was ready.
“As we approach the first very major deadline in 14 months from now, I really would like to see an honest appraisal as to whether this whole thing is on track,” he urged.
“A brand-new regulatory system must be built in order for these new regulations to work,” he explained. “From an industry point of view, we need that system to be place as soon as possible, not in the final days or even months of the transition period.”
“There needs to be appropriate lead time so that products can get approved by notified bodies and the other stakeholders that are involved in the assessment,” Bisazza continued. “We cannot eat up the entire transition period building the system.”
Echoing Perrudin’s concerns, Bisazza suggested that if product categories were at “particularly high risk” of missing the deadline – such as substance-based devices – regulators needed be “honest about that early, devise contingencies and not wait until the last minute to devise solutions.”