Testing capacity among the 17 members of Europe's association representing medical device notified bodies – TEAM-NB – that have applied for designation under the EU's Medical Device Regulation is more than 80% greater than the capacity currently on offer from the other 18 notified bodies that are not TEAM-NB-members, but which are applying for designation under the new medtech regulations.
That is the message delivered in a press release issued by TEAM-NB that focuses on the number of currently valid notified body certificates and numbers of full-time personnel and subcontractors. The press release gives a snapshot of the likely future capacity of the 35 notified bodies likely to be among the frontrunners that are designated under the new regulations. It follows hot on the heels of a longer and broader analysis of overall notified body capacity.
Little is known, still, about the intentions in terms of becoming newly designated of the other 22 or so notified bodies that are currently notified under the medical device directives.
Members of TEAM-NB accounted for 15,625 of the 19,125 total number of still valid certificates issued by 35 notified bodies in total that replied to a survey about interest in becoming designated under the MDR. These certificates were issued in the context of the current Medical Devices Directive and Active Implantable Medical Devices Directive, both of which are being replaced by the Medical Devices Regulation.
TEAM-NB Members Highly Active
When it comes down to the average number of still valid certificates per notified body at present, this equates to 546 per notified body for all 35 notified bodies who are applying for designation, and an average of 919 for the 17 TEAM-NB members among them.
All four of the notified bodies that have issued over a thousand certificates each that are still valid are TEAM-NB members. And four of the five that have issued between 500 and 1,000 certificates are also TEAM-NB members.
Only one of the non-TEAM-NB members has issued between 500 and 1,000 certificates, with the remaining 16 non-TEAM-NB members which answered the survey (one did not answer this question) having issued only up to 500 certificates, and the majority of those, 11 in total, issuing less than 250.
Key Information, But UK Uncertainties Cloud Picture
This is very useful information as it demonstrates the likely scale of the challenge ahead as companies prepare to have their certificates renewed under the directives or their products re-certified under the MDR. Of course, some products will be retired because it will not be cost-effective to pay for this expensive transition.
It also gives a good idea of where the likely capacity lies. But it needs to be borne in mind that four of the TEAM-NB members are UK notified bodies.
The technical statement issued by the UK government this week on how medical devices would be regulated if there is a no-Brexit deal states that "UK-based notified bodies would, in a ‘no-deal’ scenario, no longer be able to assess the conformity of medical devices for devices to receive the CE mark and enter the EU market."
If there is a no-deal Brexit scenario, then this cutoff date will be March 29, 2019, when the UK leaves the EU, but many questions remain unanswered, including what will be the status of CE marks already granted by UK-based notified bodies if they can no longer assess the conformity of medical devices under EU regulations?
According to a just published blog by executive director and partner at Qserve, Gert Bos, certificates from UK notified bodies will be void from March 30, 2019, in the case of a no-deal Brexit.
But even if they are considered void in the UK, it is still unclear exactly what the full impact of this will be since the now four UK notified bodies (down from five earlier this year) are working on an EU-27 presence which, in theory, may be able to take over the work currently done at their current UK headquarters. But the timing of the transitions will be key, could be messy and could cause uncertainty and disruption at a time when the medtech sector can least cope with it.
The current four UK notified bodies are: BSI; LRQA; SGS and UL. Intertek, meanwhile, which owns Amtac, closed its operations in the UK on July 1, 2018, and has moved to Sweden.
Consensus data indicates that circa 45% of all medical devices CE-marked in Europe use UK notified bodies for their conformity assessment requirements.
It is estimated that 70% of non-EU based manufacturers use UK notified body services as springboard into the EU.
The TEAM-NB press release also indicates that members of TEAM-NB have increased their full-time equivalent staff by some 27% over the last year. And once subcontractors are also taken into account, TEAM-NB claims that its organizations are on average "37% bigger than the mean of the group of all notified bodies."
TEAM-NB director Francoise Schlemmer explained that the figures concerning full-time employees aim to reflect employees in the medical device sector only.
TEAM-NB members who have applied for EU notified body designation have a mean of 176 FTEs and subcontractors, compared with 128 among the 35 notified bodies taken altogether. And TEAM-NB members account for 3,000 of the 4,490 total number of FTEs and subcontractors working for notified bodies that have applied for designation.
From the editors of Clinica