So, hope you’re well and safe, and found your way to cope with the upcoming second wave of the pandemic. Many of the video calls I have on a daily basis with people from around the world start with some discussion on health, local situation and lockdown measures. Hopes and scares. In a way more personal conversation as part of checking if it is oke to go into the content discussion of what triggered the call in the first place.
And then before we really dive into the crux of the matter, there often is this one in between question: will the EU-MDR be delayed again?
Last week we heard that all hopes were shattered, as the EU commission wiped further delay on MDR and initial delay on IVDR from their table. Industry groups has been carefully preparing it to be positioned on their table as an unavoidable truth. With the lack of notified body resources, partially due to the lag in notified body designation, with travel restrictions hindering on site audits, with the RA and QA teams in the company largely working from home whilst taking care of family at the same time, there is no alternative.
But alas, the European Commission turned it down, and so for now we are looking at hard deadlines of 25 May 2021 (MDR) and 25 May 2022 (IVDR). Of course, a no is not necessarily a no, and can grow into a not yet over time. But for now the road is closed, just as the road forward is being blocked by the very hard to organize on site visits for the first MDR and IVDR audits. Large parts of the audits can be organized remotely, but at a certain moment before the issuance of the first certificate the auditor needs to be on site. Attempt to endorse a recent MDSAP visit have not yet been honored.
So, we’re getting stuck on the upcoming deadline that will be with us in 5300 hours, which amounts to a bit over a thousand working hours. And our workload until then might be largely defined by the famous article 120.3. When it was drafted in a furious email exchange in the afternoon of January 24 2017 by a small group of experts. More or less the last words that were put on paper before the text was finalized. The last debate left us with a grace period where manufacturers would not need to be fully MDR compliant as was in the text in the morning of that day, but with some elements of the MDR. But to that aspect, there now is no escape. Negotiations done, now everyone needs to own up to the agreement.
That means that in the next few months, medical device manufacturers need to get ready. Sign up and register in the voluntarily available EUDAMED as of next month; assign the PRRC or group of PRRC officers, get the PMS and vigilance systems running, including a PMS plan for all legacy MDD products, including a PMCF plan or justification to not collect PMCF data. And getting ready to collect and write PSURs on the designated timepoints that depend on the classification of the product. Supporting those efforts, part of the quality manual should e in compliance to the EU-MDR already. And to that we can add the latest pain-point that some notified bodies have suggested that they should have the PMS and PMCF plans approved at that time.. So, check out your notified body to understand your situation.
As the workload is high, and time is very limited, we see a large increase in people needing essential training as we’re all freeing up people from all over the company that have analytical and writing skills, but have not necessarily been involved in the specific tasks, and might also not yet have been included in the MDR program. And if only it were a little PMS/PMCF plan, but with the current climate and all of us moving rapidly towards MDR compliance also for legacy devices, the expectation is that clinical claims have already been restricted to the core elements defended in the current CER, and that risk management is aligned, so that the research questions embedded in the heart of the PMS and PMCF plans stem logically from what we know and what we do not know about the individual products. And on top of that they should cover in essence the investigation into off-label use, especially into those where we have recently restricted our claims.
Also the ask to consultants is changing away from coaching and monitoring, working together into requests for complete outsourcing, as the time is getting too limited for lengthy debates. Scrumming them in place is the new agile way to fix the gaps. The only question left on the table is who the scrum master will be. The project manager inside the company, or the external supporter.
Looking back to January 2017, this is when we started our first 10-day, one day per month MDR training session. With Corona around, there is no way we can repeat that. But a focused round to get more people in the companies up to speed that are rushing in to support the final moments until the upcoming deadline in a virtual setting has been brought in place. With the great benefit of everyone logging in from their home office, instead of flying to Amsterdam for a day a month as most delegates in our first MDR training Suite did back then! Hope to see you and your colleagues in the virtual suite debates.
For support, check out our regulatory, quality, and clinical services that historically have largely been available through virtual cooperation!