As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”.
Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU) 2017/745) and the IVDR (finally numbered as Regulation (EU) 2017/746), downloadable in any language that you could possibly like.
I wish you a pleasant weekend reading them in front of the fireplace with a good glass of wine. I for myself am glad I started with that more than four years ago.
Now is the time, and this is not an exaggeration. If you have not started getting to grips with these new rules, start immediately. You will find it’s lot of work, especially if you are a small or medium sized company. You will literally need to redo all your technical files, redo all declarations of conformity, redo all clinical evaluations to a higher standard, implement all new definitions in the MDR and IVDR, deal with changes in classification and their consequences for renewed CE marking under the MDR and IVDR (especially in IVDs, software, substance based devices and nanomaterial containing devices!), implement UDI, amend your quality system, amend your vigilance and PMS procedures, implement PMCF where you not doing that already, implement new software design requirements, etc., etc., etc.
And then there is of course the Brexit impact of which nobody even knows yet what it will entail.
Impact in costs/FTEs
This will all come at a cost. Basil Akra from notified body TÜV SÜD posted this simple rough calculation on his LinkedIn profile today:
If you are not an SME then – well duh – the implementation costs will be a lot higher because more devices, so more FTEs and more costs. Where will we find all these people that we never needed before?
Gap and impact assessment
In order to know what to do specifically for implementation of the new rules you have to find the gaps and assess them for impact. If you are not already doing this, start now. Otherwise you’ll be too late to for example complete any additional clinical studies you might need to do to meet the new burden of clinical data under the MDR and obtain a new CE mark under the new regulations. Especially for IVDs the new IVDR is an enormous step up in requirements for clinical data, clinical performance evaluation and dossier / procedural requirements. And for IVDs there are even less experts available in the market or at your competitors, so catch them while you can.
If you you have no idea where to start, or have an idea but would like to be inspired, I recommend you visit our seminar in Amsterdam this Wednesday (10 May) afternoon, which is only and specifically about transition and implementation.
Interesting point regarding the costs of the new regulation. Mr. Akra’s estimate of costs does not include the application costs to the notified body, foreign manufacturer’s, expert panels and many other costs. I’m not lawyer, but I think in the US no new Act can be created without a cost estimate. Was there no cost estimate for the EU MDR?
Hi Kriss, also in the EU impact assessments are mandatory for new legislation and one was done for the MDR and IVDR. The impact assessment was however performed for the initial Commission proposal, and not for the final result that was published today. In the more than fours years of legislative struggle and ardent political wishes a lot has changed that I think also affected the original impact assessment. The Commission could have chosen to update the impact assessment as the proposal was changed considerably first by the Parliament and then by the Council (EU impact assessment policy even says that this would be a very good idea), but this has not happened – probably due to capacity restrictions at the Commission’s medical devices unit (which is rather understaffed). Best regards, Erik
Do you have any thoughts on how the new regulations might affect the MEDDEVs?