One hundred and sixty one days out, and we see today finally the long-expected second erratum being finalized. A great relief for manufacturers of class I MDD products that are being up-classified under the MDR. Many companies are putting all their priority on class I products, in order to comply with the new regulation on May 26 2020, as there is a heard deadline for such products. But the same deadline was also in place for all class I devices being up-classified, and although manufacturers could finish at their end, there was no time for the few designated notified bodies to review and certify such products in a timely fashion.
We slowly see the number of notified bodies rising. Not yet the 20 promised by the end of the year, but rather 8 (MDR) and 2 (IVDR), and if we look at the actual notified bodies, we see only 7 entities as BSI has a double MDR designation for essentially the same workforce, and the IVDR notified bodies are also designated for MDR. The situation for IVDR is looking really grim, as not many are even 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.
Where the commission currently predicts a bumpy ride for the EU-MDR, the IVDR ride will be especially hard, as it will also be in the dark…. The number of expected guidance documents on IVDR is very limited, and even for those that are scheduled to be published, publication dates are not fixed.
For MDR we are seeing more and more guidance now reaching publication stage, and ultimately the collection is now reaching the triple point, where we move from uncertain to clear interpretations, skipping the ‘let’s try to follow the intentions’ status.
A key example is the latest guidance on sampling of dossiers by notified bodies as part of their conformity assessment. Some key changes to the softer views some had agreed with their clients, so sampling plans and MDR priorities and submission schedules are drastically being revised by some. Especially the fact that in submitting various dossiers under the same CND coding over time the independent sampling will need to stay in place is having its effect. Groups of products will need to be prepared for submission at the same time to keep the number of assessments within the reasonable limit, where notified body resources are potentially available.
For these reviews meanwhile the first pricings are getting out. Some companies are in shock, whereas others had anticipated the significant pay rises. Interesting is to see that some keep their dedicated extra high price reviews, whereas others seem to have moved to one service level for all.
In looking at the MDR programs being implemented, a shift seems to be occurring in recent months away from core focus on clinical and supplier control to biocompatibility and toxicity. Well, not a replacement, but rather an extra focus. The clinical vortex is starting to move heavily into PMCF data collection, and supplier control is challenged by getting sufficient access to the details of the product compositions. In many case products will need to be redesigned to remove / reduce for example phthalates. However, companies now starting on that journey will only see that as option to certify under the MDR, as MDD certification is on its last legs. Essentially the biocomp and toxicity testing is what is going to absorb much of the budgets for 2020, as many have old datasets, toxicity has been underplayed, and notified bodies are starting to ask for specific tests outside of the standard tests identified within the ISO 10993 series.
Meanwhile much debate online is ongoing (and elsewhere) on the minimum deliverables under MDR art 120.3; a line that was kept to its essentials, so we could move ahead into the grace period in a smooth way. The message to industry is getting clearer. 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 few days of rest and family time ahead of us next week but following that let’s go to work with double speed and energy!
Gert