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Two EU Notified Body Frontrunners In Race For Designation Under New Regulations
The latest revelations in London and Brussels over the last week show concrete progress is being made toward the designation of notified bodies. But which organizations will be named first and when?
There are currently two front-runners in the race for medtech testing and certification bodies to be designated as notified bodies under the EU’s new Medical Device Regulations.
Names of the two leading organizations have not been made public. The announcement of formal appointments is eagerly awaited by device companies anxious to get on with the process of complying with the new regulations and securing a competitive advantage of being among the first with new CE-mark numbers.
The European Commission has already received the corrective and preventive action (CAPA) plans from the two applicants. The plans are intended to correct any non-conformities that have come up following scrutiny by the Commission-led Joint Assessment Teams (JATs).
“Everything is going according to plan,” says Erik Hansson, deputy head of the unit that oversees medical devices at the European Commission.
The JATs are made up of a representative from the European Commission and representatives from at least two different member states. The next step is for the JATs who reviewed the applicants to prepare opinions on the CAPAs and forward them to the notified body applicant’s national designating authority. That triggers dialogue toward final designation that can take up to nine months.
Although no names have been released, ongoing activities and behavior suggest that the two front-runners might be BSI UK (or BSI Netherlands) and TÜV SÜD Product Service (Germany).
It is hard to judge when they will be designated, however. The authorities are keeping their cards close to their chest.
Based on the flowchart developed by the European Commission’s Notified Body Oversight Group (NBOG) last year, it appears that progress for the front-runners is on track for designations to occur next July. (Also see “EU Notified Body Designation Process: 20-Month Wait Is Not Good News” – Medtech Insight, 28 Nov, 2017.) But there has been some background discussion that the first designations could processed as early as next January.
Erik Hansson, deputy head of the unit that oversees medical devices at the European Commission, was upbeat on the topic when he spoke at the European Symposium on New Medical Device Regulations in Brussels on Oct. 22. “Everything is going according to plan,” he said, adding, “We didn’t expect notified bodies to have been designated at this point.”
Hansson made it clear that the European Commission is “ready on our side.” He said at one point that the first designations “may not be too far in the future” and then later that they will “start to be redesignated very soon.” Although, he gave nothing away about actual dates nor about actual numbers of those likely to be designated over the next year.
The main factor now, he said at the meeting organized by the European Association of Authorized Representatives, “is the speed at which the notified bodies can deal with problems identified in the joint assessment.”
He also revealed that the European Commission is expecting more applications and added that the “majority of notified bodies are radically investing in resources.”
Some More Pointers To Progress
It was Graeme Tunbridge, a device expert at the UK regulator, the MHRA, who provided the biggest clue as to the numbers of notified bodies coming through the system.
Speaking at the annual regulatory conference of the Association of British Healthcare Industries on Oct. 18 in London, Tunbridge, who is group manager for device regulatory affairs at the MHRA, revealed that a total of 11 notified body joint assessments have been carried out under the EU Medical Device and IVD Regulations and that 11 more have been scheduled to take place over the next few months.
More specifically, nine joint assessments have been carried out so far under the MDR and 2 under the IVDR. Under the MDR, another seven are scheduled for 2018 and one more for January. Three assessments are scheduled under the IVDR.
Designation Announcement Dilemma
Notified bodies have long wanted to know whether the designations will be announced individually or in batches.
Some in the space have expressed concerns about unfair advantages for those nominated first, but, on the other hand, the device sector urgently needs these bodies to get on with the job of assessing products at the earliest possible opportunity.
Timing is also crucial because, as Bassil Akra, VP, TÜV SÜD Product Service, reminded the Brussels audience this week. “Every notified body will lose its certifications under the current directives” on May 26, 2020, for medical devices and May 26, 2022, for IVDs, he emphasized.
But while the pressure is on to have notified bodies designated as soon as possible, it is worth remembering that the system itself is far from being ready to enable manufacturers to fully comply. The most critical documents and structures that will enable compliance are not ready. There are common specifications, implementing acts, standards, delegated and implementing acts, expert panels and reference laboratories, among other documents and structures, that are still slowly making their way through the system into reality. But, equally, all manufacturers are being urged to move forward with compliance efforts without delay – even if they have to make changes at a later stage.
One example is the new version of the EU’s medical device database, Eudamed, which is due on March 25, 2020, officials specified at the ABHI meeting in London. That will give the sector just two months to upload all the critical information required – a timeframe that many argue is too short.