(This is an edited transcript of the video clip, but here’s the link to the full presentation)
Do you really want to sell your product in Europe? Are you sure?
We’re in the midst of a major paradigm shift between the FDA and the EU, so you might want to reconsider that decision.
Once upon a time, the FDA had the well-deserved reputation of being the slowest place to bring a product to market, requiring a lot of clinical trial data. The EU, on the other hand, had a reputation for ease of entry and more reliance on performance standards than clinical trials.
That paradigm has shifted dramatically with MDR and the FDA’s strategic priority to be where people want to bring their products to market first or in parallel with other major markets.
To further complicate things, you have the traditional EU 27 member states, but you also have the European Free Trade Association that is informally a part of it. You also have Switzerland and the United Kingdom working on succeeding from that whole arrangement, and Turkey may well end up in Turxit. These fractions mean the potential for three different versions of a CE mark, depending on which areas of Europe you’re trying to enter.
(There is) the potential for three different versions of the CE mark, depending on which areas of Europe you’re trying to enter
Translation remains a really big issue. When MDR was first written, it was negotiated and formalized in English, and then the final product was translated into the rest of the member state languages. That’s 24 languages that MDR was translated into, and a whole lot got lost between what was negotiated in English and what got translated into in the different local dialects. And because it’s not really clear what MDR meant in the first place, it’s almost not even legislation anymore – it’s interpretation.
Still want to sell your product in Europe? But wait – there’s more!
The main challenges for manufacturers pursuing MDR certification are the clinical evaluation, the transition of legacy devices, the expectations around validation testing, and risk analysis requirements. More importantly, the emphasis on the post-market is exponentially above what it used to be for MDD, but certainly above what FDA expects.
To bring products to market in the US, there’s very little post-market activity outside of adverse event reporting. Under the MDD, we always had the CER and maybe PMCF to an extent, but they weren’t quite as much of the focus. They were a part of the technical file instead of almost a whole standalone process. Now under MDR, you can expect to put as much work into your post-market, as you put into your pre-market.
Under MDR, you can expect to put as much work into your post-market as you put into your pre-market
Moving linearly through the FDA process to bring your product to market is pretty much a one-piece flow all the way, and the only way you end up back in the start is if you make a change to your device that warrants a new 510(K).
In contrast, notified bodies tell their customers that, just to get to the certificate, they have to go through a pre-application, through an application, through initial certification, but then they end up down in the perpetual motion machine that is the re-certification process. It just leaves manufacturers a little dizzy.
The other challenge is that as of today, there are 24 notified bodies designated for MDR, and it makes a difference who a manufacturer chooses, because the different notified bodies are not consistent in their implementation.
For instance, the Netherlands will allow remote auditing of the MDR, whereas Germany does not. And that’s just one of many scenarios that you need to consider when you select a notified body. It’s also important to understand how your notified body defines significant change, as that can affect the validity of your certificate. And if you decide you’re going to divest product lines, you don’t get to sell your existing certificate. Changing ownership of the product restarts the whole certification process under MDR.
If you decide you’re going to divest product lines, you don’t get to sell your existing certificate. Changing ownership of the product restarts the whole certification process under MDR
As of December 2020, only 1% of manufacturers have successfully transitioned to MDR certification. Why? Because for the most part, the large companies that have a lot of financial and internal technical resources are going to maintain their European market clearance – period.
Only 10% of medical device manufacturers are in the process of transitioning, but where are the other 90%? Good question, and this is going to really create a possible extinction of commoditized products that are currently on the market.
Rethinking the decision to sell your product in Europe? For sure, any manufacturer with new and novel ideas is going to think twice about the clinical data and other requirements that they need to meet to bring a product to market in Europe. This will negatively impact patients in the EU, where there could be fewer products on the market and limited access to novel technologies that treat rare disease states.
Link to the full presentation on YouTube: https://youtu.be/f4suuXDaNWA
