Completely in line with expectations the Parliament adopted the texts of the MDR and the IVDR yesterday. I have nothing to add to that in addition to previous posts in this blog. It is what it already was. The texts can be found here.
This means that we are now looking at publication in the Official Journal beginning of May (you will finally have the final official texts) and entry into force 20 days later (expect beginning of June). It is now inevitable.
The transitional periods of 3 years (MDR) and 5 years (IVDR) will start then and the train will leave the station and you will be on board, whether you like it or not. If you are still stuck in one stage or another of the classic stages of grief, you had better pick yourself up and move straight to the stage of acceptance. Many companies I know are stuck in anger, denial or depression, and are some still bargaining (we are past possibilities for lobbying on the regulations now, although there are some possibilities now in implementation)), but at this point this kind of drama is wasted energy.
Yes, many things are still uncertain and unclear and still need to be fleshed out in more detail in implementing acts etc., but this is not an excuse to sit on your hands and wait while inevitability catches up with you in the worst possible way.
Actually, things are pretty clear already: you need to transition your products into the new system and we know what it looks like. If you don’t transition, or if you don’t manage in time – off the cliff you go: you cannot place the products on the market in the EU anymore. There is no grandfathering, only a hard stop.
So, what would Brian Boitano do?
He’d make a plan, and he’d follow through. I have discussed all the substantive requirements of both regulations in detail on this blog and they have been discussed by many others too, so you are familiar with them already, right? No need to repeat all of that.
The next step is to look at each of your products in detail and decide for each product if you will replace, retire or remediate it depending on what is required to bring it into compliance with the new regulations.
You may want to try and exploit the limited grace periods of four (MDR) and two (IVDR) years that are given after the transitional period for devices with a certificate that is renewed during the transitional period. However, relying on these comes at a cost that you need to be aware of (essentially you cannot change your device or intended purpose anymore).
Also, remember that this option is not available for any of the currently self certified devices (because they don’t have a certificate that can be renewed). This means that you may have a very steep and quick learning curve ahead if your device goes from class I MDD to class III MDR (which is the case for a lot of clinical decision support software and substance based devices) or from self-certified IVD to class D IVD under the IVDR (the large majority of currently self certified IVDs will need a notified body certificate under the IVDR). And these are just the most extreme examples.
And then there are the overall changes you have to make to basically everything you do with respect to the EU market, because the changes are not limited to products but also affect your quality system, risk management, vigilance procedures and so on.
So you do you make a plan like that?
Save the date of 10 May for a seminar on implementation and transition to MDR and IVDR at Axon
You can invent your own wheel or you can see how others are approaching the situation. That’s why I decided to organise a seminar at Axon Lawyers specifically regarding implementation and transition planning. I have teamed up with Gert Bos from Qserve and the Dutch Healthcare Inspectorate has graciously agreed to present its view on transition and implementation. This will be an afternoon of deep diving into how to get your organisation from the MDD to MDR and from the IVDD to IVDR in a meaningful and intelligent way.
The seminar will take place on Wednesday 10 May in the late afternoon. As always it’s free and you can bring as many colleagues / friends as you like. If you’re on our mailing list, you will receive an invitation. If you’re not but would like to be, let me know. Otherwise you can already RSVP to Marjon Kuijs, our office manager with the name of each person that will attend so we can plan for enough chairs and drinks and print everyone’s name on a badge.
I’m taking the jump off the cliff option. After a few years, they will be forced to revisit this, because the latest technologies will be available in the US first and not to Europeans. Many products will now require clinical trials for the EU, that can be 510(k) cleared in the US without any clinical data at all. The finger pointing will switch directions. None of this fixes the root cause. Corruption in the industry by senior management, like the PIP scandal, will continue. No notified body auditor can catch this stuff, if all the documentation is falsified.
Hi Kriss, everybody should of course make their own choices in this matter, although betting on the EU quickly changing laws or even policy is a bet I personally would not risk the EU market on for my company. If your company can afford to not be in the EU market for some years, it might be a rational approach but this would be different for many other companies. Best regards, Erik
The seminar looks interesting.
Will there be a chance to dial in if I cannot attend in person?
Where will the seminar be?
Pete Ratcliffe, PhD
Regulatory Affairs Manager
Corporate Services EMEA
Tel: 01793 607634
Hi Peter, we typically don’t provide dial in because the seminar is off-site and in a very large space because we usually have 100+ attendees (which makes good audio at a distance quite a challenge). We do however always post the presentations on our website afterwards. Maybe your Dutch colleagues are able to join? Best regards, Erik