With just 9 months to go until the go-live date of the EU-MDR, the stress and anxiety are rapidly increasing. Cries for extension are met with slow progress in implementation of the new legislation. On the IVDR front, it is still quiet, as many appear not to focus on this challenge yet, as there is plenty of time. So, what is happening? A selection, to get you thinking and enhance your efforts to comply!
The joint authority assessments are in full swing. Before summer the EU Commission anticipated up to 20 could, in theory, be designated before the end of the year. So far, we’ve seen 4, two large ones (of which one might very well loose the designation late October), and two with a more restricted focus. And as after the notification finally landed on Nando it is taking some time to get started, the number of ongoing dossier reviews and audits towards MDR is still very low. But the anticipation is that in the upcoming MDCG meetings later this year, a growing number of Notified Bodies will be designated.
More concerning is the situation for IVDR designated notified bodies. None passed so far, and not many are trying. With two and a half year to go in the transition period, this might seem oke, but with limited Notified Body resource, and large numbers of high-risk devices in class C and D to be reviewed for the very first time by Notified Bodies, this does not predict a nice and smooth ride. Especially not for high-risk devices, as the labs that need to validate the products, and prepare for batch release still need to be assigned as well; after which designated notified bodies a contract with them.
Next to that, six notified bodies have meanwhile withdrawn their application for the new legislation. A grim situation, that is leading to many requests and industry as well as governments (e.g. US government) pushes for a general extension of the transition period.
And although that is far from reality at this stage, the first shift in transition allowance seems to be found for a particular group of devices: the class I surgical instruments. These would all need to be CE market after receiving a Notified Body certificate, which is unfeasible in the current situation. So, authorities have widened the scope of the upcoming 4-year grace period to include this critical group of products that are basically used in every surgical procedure. The method of making this change is found in some additional wording in the upcoming corrigendum of the EU-MDR.
Secondly, the publication of technical interpretations is slowly ramping up. Where initial guidance was focused on notified body designation, and getting UDI and EUDAMED up and running, the shift has been made to more content guidance, on topics like “person responsible for regulatory compliance”, and “implant card”; guidance on clinical evaluation is expected soon, as well as some more “how-to”-topics.
So, in the absence of clear sign extensions are being debated, we should all enhance our efforts to come a close to compliance as possible, on the short term. That is getting more and more obvious, as companies are struggling to get MDD renewals through, with Notified Body expectations rapidly moving towards the stricter and stronger MDR requirements; Many issues arise from the generation of clinical data in PMCF phase. This might best be seen as a prelude to the last sentence of the first paragraph of article 120.3: ‘However, the requirements of this Regulation relating to postmarket surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives’. A simple wording was chosen here, but this should not be treated lightly. It is just short of saying that the manufacturer needs to be fully MDR compliant, apart from having completed the notified body assessments. The severity of this impact is slowly coming to light, and debates between manufacturers and their notified body, but also between notified body and authorities are getting tougher. For example, on the double requirements to audit and supervise companies that are certified under MDD and under MDR at the same time, which in theory has been indicated by the commission to be feasible. As authorities are pushing for double review, some notified bodies are starting to change position saying the transfer from MDD to MDR should be a rapid per company, rather than a phased approach that we find in quite some transition plans.
But the message to industry is getting cleared. Get your act together and come as close to MDR compliance by 25 May 2020 (IVDR: 25 May 2022) as you can, in order to smoothly meet the rapidly changing demands from your notified body. A good thing the summer breaks are over, so we can get to work!