In vitro diagnostic (IVD) manufacturers face a major regulatory leap as the new In Vitro Diagnostics Regulation (IVDR) takes hold, with many products requiring notified body oversight for the first time. Early indications suggest the number of notified bodies designated to the IVDR could fall short of demand.
In a recent member survey
by Team-NB, just 11 organizations said they plan to apply for IVDR status, about half the number designating to the Medical Device Regulation. Of those, eight submitted IVDR applications last year, while three plan to do so this year.
These include all 10 notified bodies currently designated against the IVD Directive, plus one new notified body, said Françoise Schlemmer, director of Team-NB. It’s worth noting, though, that the survey only covered Team-NB’s 24 members — less than half the 59 notified bodies operating in Europe. Currently, 22 of those have IVDD status.
Gauging Demand for Notified Body Services
The European IVD industry is an €11 billion market with about 3,000 companies and 40,000 products. Most IVDs today are self-certified, but that will change with the incoming IVDR. Under the new regulation, approximately 35,200 will need notified body oversight, according to industry estimates.
Those numbers and the uncertainty about notified body capacity have many in the industry worried.
“Some [IVD manufacturers] are getting anxious indeed,” said Gert Bos, executive director and partner at Qserve Group BV.
MedTech Europe estimates that if just 11 notified bodies got IVDR status, each organization would need to process 3,200 IVDs. Larger buy-in would ease that load, but only so much.
“Assuming that all 22 notified bodies will apply for designation under the IVD Regulation, each notified body would on average need to assess at least 1,600 IVDs,” Merlin Rietschel, senior manager of regulations and industrial policy at MedTech Europe, told Focus
. “This is an increase in notified body workload of 780%, or almost by a factor of eight.”
Erik Vollebregt, founding partner at Axon Lawyers, fears IVD companies could face a “serious bottleneck” when it comes time to seek CE certification. With the 26 May 2022 IVDR application date still several years away, many manufacturers aren’t fully focused on the issue, and that’s a mistake, he said via email.
A limited number of notified bodies may choose to work with large, established IVD manufacturers first, leaving small- and mid-size companies — which make up 95% of the industry — without an immediate path to certification. “Manufacturers that already have CE certified IVDs have an advantage, as they have experience with notified bodies and are customers already,” Vollebregt said.
Sue Spencer, global service line director – regulatory at UL, agreed. “Our first duty is to serve our current IVDD and ISO 13485 manufacturers well, and take on additional clients as capacity permits,” she wrote in an email.
Notified bodies are also interested in innovation, Bos noted, which could affect the scope and choice of IVDs available in the market. Old-style legacy products from small players could get squeezed out of the market in favor of newer options.
There is also the question of Brexit. Without agreement that the UK stays connected to the EU in a manner like Switzerland, it will no longer have notified bodies after March 2019, Vollebregt said. That creates all kinds of issues for companies that have not engaged a notified body before 26 May 2022.
Designations can Take up to 18 Months
Across Europe, efforts to plan for product assessments are hampered by uncertainty over which notified bodies will be notified and available to accept conformity assessment applications.
The issue isn’t just about numbers, but time and capacity as well. It takes on average 18 months for a notified body to be designated, somewhat less if the organization doesn’t have many nonconformities to correct. That is followed by a notification procedure. It is unclear how long that will take.
“We understand it depends on how responsive member states will be and how savvy their IT skills will be,” Rietschel said.
Meanwhile, there are going to be many more IVDs needing notified body supervision for the first time and more breadth of notified body coverage to handle the new segments of the IVD industry requiring certification. Regulators, manufacturers and notified bodies will be competing for a limited pool of experts on IVDs and the new requirements.
According to Oliver Bisazza, director of regulations and industrial policy at MedTech Europe, an individual needs at least four years of hands-on experience dealing with a specific device to qualify as an expert. Those hired by notified bodies will need training audits and certain other procedures as well.
Another cog in the wheel: Besides notified bodies, which both Class C and D IVDs will need, Class D products will need expert panels and reference labs to be in place in order to come to market.
While all this concerns industry, it could also be seen as an opportunity.
“We do anticipate there will be newcomers … coming forward as IVD notified bodies or existing notified bodies taking care of IVDs for the first time,” Bisazza said.
‘Get a First File Ready’
Meanwhile, MedTech Europe has sought assurances from the European Commission and member state designating authorities that there will be enough expert auditors to handle notified body applications quickly and efficiently. The Commission claims readiness, saying it is prepared to handle 40 to 50 assessments a year. With the current number of applications, that won’t be problem. But things could change quickly if more notified bodies enter the field.
The Commission has given manufacturers five years to transition to the new regulation, but there is nothing built into the IVDR that explains what happens if notified bodies aren’t available in time or don’t exist for particular segments of the industry. “If a notified body is not in place and available to a given manufacturer, there’s no easy way around that,” Bisazza says.
Experts urge companies to start looking for a notified body now.
“Become an existing client,” said Bos. “Get a first file ready and apply for IVDR certification the day your notified body of choice gets a designation.”
Manufacturers that start this effort too late could find themselves shut out until more resources become available, Spencer warned. “Customers realize there is a queue, but they don’t know where they are in that queue. They’re concerned whether latecomers could jump the queue, as well,” she said. Transparency will be key in reassuring customers that their needs will be taken care of.
For now, manufacturers with products certified under the IVD Directive can renew those certificates. MedTech Europe anticipates more concrete information on the issue in the coming months.