Bottleneck of bottlenecks for notified body capacity
People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large share of the currently CE certified IVDs in the EU. This expertise and capacity will now be lost and not be available for the IVDR transition and for soft transition under the IVDR. And the general medical devices capacity is also lost of course too.
The case of LRQA
The case of LRQA shows that notified bodies are not only suffering in the end of the long tail, but also at the beginning of the tail. Three things are happening now.
First, LRQA is ceasing its MDD and IVDD services – this means that its current customers need to transfer to another notified body. Customers that had relied on LRQA to support them for soft transition (2020-2024 under MDD or 2022-2024 under IVDD) have to find another currently notified notified body to support them. Since LRQA was servicing a large part of the IVD industry that need CE certificates currently, this will be difficult and a bottleneck in itself. A transfer to another notified body may take longer than you have until the date of application for the MDR (26 May 2020). Also, customers of LRQA will need to transfer as soon as they can, because when a notified body closes down, the certificates will be withdrawn – regardless of the expiry date on the certificate (this is something that many manufacturers still misunderstand). It means that customers of LRQA may need to massively apply for orphaning protection with competent authorities if they cannot complete their transfer before LRQA closes its doors for the directives (90 days as of 12 June 2019).
Secondly, LRQA is abandoning its pursuit of a notified body in the Netherlands – this means that their Brexit hedge is terminated and less of the current capacity of notified bodies in the UK ends up being transferred to the EU27, so less total capacity available.
Finally, they announce that they are not pursuing their MDR and IVDR notification. This means that this capacity will not be available for the IVDR transition, which is a pity given the enormous amount of currently non-CE certified IVDs that need to be CE certified under the IVDR.
LRQA will probably not be the last
So, we are faced with the scenario that notified body capacity is rapidly decreasing, and a lot faster than new capacity is being added. In fact, new capacity is not being added because no new notified bodies are entering the market for certification services under the MDR and IVDR – the only new ones are UK notified bodies transferring to EU27, of which LRQA was one. NSF, the only really new NB on the block that I knew about, has abandoned its IVDR application in the mean time. 9 of of the 22 Team-NB IVDD notified bodies will not apply for IVDR, and the rest is in various stages of application or considering to apply for IVDR. MDR figures are also looking bleak.
You do not need to be a mathematical genius to see that with a projected increase of notified body workload of 780% (source: MedTech Europe) and a rapidly decreasing installed base of capacity of notified bodies, there will a bottleneck of bottlenecks. I predict that LRQA will not be the last notified body to abandon medical devices altogether.
Some Member States are getting kind of worried too. The Germans and Irish drew attention to the bottleneck recently asked for attention to this at the Employment, Social Policy, Health and Consumer Affairs Council session on 14 June 2019 in the general context of implementation of the MDR and IVDR (which, as I have blogged, is far from ideal to begin with):
“[…] based on the number of notified bodies which are expected to be available on time, there will still be significantly fewer notified bodies than currently exist. In addition, data is not available on the capacity these designated bodies will afford the system.
[…] The concerns expressed are that these products cannot continue to be placed on the market under their existing Directive certificate up until 2024, like most other existing medical devices and that this will lead to market shortages.”
In other words – I will translate these euphemisms for you – we are feeling our way along in the coal mine of the new unfinished regulatory system, a cage with a bunch of dead canaries in our hand, and we have no idea if what we are doing is going to produce the regulatory approval capacity we need.
MedTech Europe has recently used uncharacteristically strong language in this regard in an open letter to the European Commission:
“This situation is clearly untenable, and time has run out to build a functioning regulatory system. This set of circumstances will profoundly disrupt the medical technology internal market and create yet another significant ‘Cliff Edge’ putting patient safety, healthcare services and EU healthcare environment in a major disarray.”
I agree completely with them. In the end, this is about continuity of healthcare services – should be kind of important to member states as well.
What to do
For devices companies this means that more than ever you – apart from having your MDR/IVDR transition totally sorted out and on track – have to vigilant to signals from your notified body that they may be closing down, and be in absolute shipshape with your compliance in order to have a chance of a quick transfer to another notified body. In addition, you need to understand how the orphaning process works in case you need it. So plan for different scenarios, and include the worst in them. As I have told several CEOs of devices companies downplaying things in the mean time “It’s only core business – how can that ever be relevant to the company, right?”