I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where everyone will be by the time the transitional period of the MDR ends and then when the IVDR transitional period ends.
This post is intended to address some seemingly quite ingrained misunderstandings about the MDR and IVDR. If you don’t believe me, that’s fine. Double check with your international branch associations, MedTech Europe, COCIR, Advamed – they will tell you the same.
No grandfathering, no extensions
Many companies misunderstand the transitional regime and think that medical devices and IVDs currently on the EU market with a valid CE mark will automatically slide into the new system. This is not the case.
Other companies that understand the transitional system somewhat better and realise that there will be a bottleneck in notified body capacity towards the end of the MDR and IVDR transitional periods. I have heard management of those companies say: ‘the EU cannot afford chaos in the market, they will have to give companies more time’. There is nothing to indicate that the EU is planning that and there is no precedent of the EU doing this.
As I have repeated like a broken record: there will be no grandfathering and you should not count on the EU relaxing the deadlines. I mean, you could but it would be a kind of ‘kamikaze-with-option-of-survival’ business strategy that is difficult to explain to shareholders:
-“What’s your plan again?”
-“Our plan is to – rather than put in the work now that is required for being compliant in time – bet on the EU legislator changing the law against all odds and expectations, and in a way they haven’t done before in the EU. Oh yeah, and we also bet on them changing the law in a way that will actually work for us.”
Sounds very much like a nomination for a corporate Darwin award to me, pardon the cynicism. It’s like juggling burning running chainsaws as a business model.
If your management does not understand this, tell them in these words: the company will not be able to sell products in the EU anymore if you do not get this right in time. Cash flow will collapse, the business will tank, competitors will take your market share, your company may go bankrupt or be acquired by another as the sitting duck that it has become. It will be ugly, it will be costly and the business may not recover. And they could have seen it coming from light years away and you have been told about too. But hey, why worry about this – it’s only the company core business, right?
Start tackling this thing
Deadlines in the mirror of denial are closer than they appear – just remember that I told you to start sooner rather than later. Make a plan and follow through – see here for the presentations at my firm’s seminar on this by the Dutch competent authority IGZ, Qserve and myself.
I will be speaking about this at the RAPS and Advamed conferences in Washington DC and San Jose in September and you can ask me anything you want there, or just contact me before. These are good conferences to go to to get the full picture. But please do not do nothing.