LONDON – No one is in favor of delaying implementation, but there are now doubts being expressed across Europe that the infrastructure required for the medical devices regulation (MDR) will not be in place by May 2020, when the new rules are due to take effect.
The main concern is that the notified bodies which are responsible for certifying medical devices will not have upgraded their processes and been passed as fit to assess devices under the stricter requirements of MDR.
To date, only two notified bodies, BSI Group (formerly in the U.K., but recently moved to the Netherlands in order to remain compliant with MDR when the U.K. leaves the EU) and TUV Sud Product Services in Germany, have completed the assessment.
Others have decided the new regime is too onerous and said they are pulling out of the business.
Earlier this month, UL International Ltd. in the U.K. said it is to cease operation as a notified body. Two weeks earlier, Lloyds Register Quality Assurance (LRQA), also U.K.-based, announced it too, is withdrawing its medical devices assurance services. Swiss notified body QS Zurich also said it was pulling out last month.
According to the European Commission, which is overseeing the process of upgrading notified bodies to conduct conformity assessments under MDR, 51 applications have been received, but only 20 notified bodies will be designated by the end of 2019.
However, there is no information on what the capacity of these upgraded notified bodies will be. And while 20 MDR-compliant notified bodies might be enough to assess products coming to market for the first time, there is no grandfathering provision in MDR, which means all existing devices need to be recertified.
Before submitting applications for re-certification, companies with me-too products that currently are approved based on equivalence with a reference product, are required to gather clinical evidence that their products meet the higher standards set by MDR.
There is a provision under which companies can apply for an extension – to 2024 – before re-certifying devices currently on the market. However, this 'grace period' does not apply to all devices, and companies must apply to national regulatory agencies to get approval for such a delay.
The system is getting further clogged because notified bodies withdrawing from the market have given as little as 90 days' notice, leaving products 'orphaned' and companies scrambling to find new notified bodies at a time when these organizations are fewer in number and distracted by the process of securing their own re-certification.
"All the industry is suddenly in need of notified bodies; the notified bodies are under huge demand at the same time as having to apply for their own jobs," said Alex Denoon, head of the life sciences regulatory team at the law firm Bristows, in London.
MDR passed into law in 2017, with three years for notified bodies to be upgraded and products recertified, but Denoon told BioWorld MedTech, "People underestimated how difficult it would be."
The system is now so backed up that new devices cannot get speedy approvals either, according to Denoon. "I'm aware of clients with innovative products which are stalled in the process and that can't be placed on the market," he said.
Alarm bells are ringing in health ministries across the EU. In June, Ireland and Germany, the two largest exporters of medical devices in Europe, had to get the matter added to the agenda of a regular meeting of health ministers as 'any other business' in order to express collective concern to the European Commission.
It was stressed that these concerns "are not about the substance of the regulation" but the "state of readiness." People across the sector are worried about the number, availability and capacity of notified bodies, Ireland's health minister told the meeting.
Similarly, Belgium's health minister said the country is not in favor of an unnecessary delay in implementation, but is "very worried about preparations and capacity." Greece's minister said there is a fear that in May 2020 "thousands of medical devices will become non-compliant." All other health ministers speaking at the meeting expressed the same concerns.
While the immediate focus is medical devices, there also are worries about the new regulation on in vitro diagnostics. That does not become fully applicable until May 2022, but it represents a more profound change when compared to the existing rules.
It is anticipated that under the regulation more than 80% of in vitro diagnostic devices will require assessment and certification by a notified body before being placed on the EU market. In contrast, today over 80% of such devices are assessed by the manufacturer and do not require notified body certification.
EU health commissioner Vytenis Andriukaitis was all bland reassurance responding to the representations of health ministers, saying implementation of MDR "is a significant challenge for the whole sector, but we are on course to meet it."
The new governance structure is in place and fully operational, Andriukaitis said. The Eudamed program to set up a new database of medical devices has the core modules in place and will be functional on time, and the unique identifier system for tagging each device is ready.
On the crucial issue of upgrading notified bodies, Andruikatis said 51 applications have been received and 20 notified bodies will be designated by the end of the year. The stricter requirements mean, "it is not a surprise" there are fewer of them," he said, adding, "May 2020 is a realistic and achievable deadline."
But according to Denoon, the time taken for a notified body to certify a device has gone from 3-4 months to two years. In part this is a result of the additional scrutiny that MDR requires, but mostly it is because a shortage of notified body resources means devices are queued up awaiting appraisal.
That is further compounded because new categories have been introduced. For example, software as a device is subject to assessment for the first time, under MDR. This is creating demand for certification of a type of product of which notified bodies have no previous experience, Denoon said.