With the new EU Medical Device Regulations (MDR) due to become law in May 2020, medtech manufacturers need to get ready for a new regulatory framework. In this article, we talk to Isocele Conseil’s Emilie Fournier, and look at how they can better prepare to obtain regulatory approval
Following much-publicised patient safety concerns (The 2012 PIP breast implant scandal being the most notable), the European Union decided to draw up to regulations to replace the existing directives, which date back to the 1990s. The result is the EU Medical Device Regulations (MDR), which were formally published last May. The MDR aims to strengthen the regulatory platform across the EU, while harmonising and simplifying the rules through increased transparency and improved product traceability.
The MDR, which represents one of the most disruptive changes in the medical device sector, will become law in 2020. They will severely impact how manufacturers prepare for regulatory approval. It’s imperative that all medical device companies operating in Europe prepare for the MDR as its impact will be significant.
According to regulatory consultant Emilie Fournier, manufacturers need to get ready now, and they need to start by preparing to provide clinical data.
‘Manufacturers need to plan well in advance, especially with regards to providing clinical data. It was advisable to provide clinical data but it wasn’t mandatory. Some manufacturers would provide it but not all of them. (Mandatory clinical data) is one of the biggest changes.’
However, manufactures are still in the dark over other parts of the MDR, which pose a different sort of challenge. Fournier believes that the Eudamed medical device database (which regulators, providers and the public can access technical data, clinical trial results and adverse event reports) is one such example.
‘They also need to consider the medical device database (Eudamed). The issue there is that database is not available yet, so nobody knows how it will be implemented and how manufacturers will use it.’
Manufacturers preparing for regulatory approval will be subjected to greater scrutiny than ever before. Along with the aforementioned considerations, they need to bear in mind that all of their medical devices will be subjected to independent safety and performance assessments.
Greater responsibilities will also be imposed on the Notified Bodies (include the power to audit manufacturers), which will be subjected to increased scrutiny and will need to be designated under the MDR. This may be bad news for many of them, according to Fournier.
‘A lot of notified bodies will be unable to comply with the new regulations. They won’t all be able to audit, so it’s likely you’ll see a decrease in the number of notified bodies as a result of the MDR.’
Such has been the reaction to the MDR that some experts believe that they may cause manufacturers to reconsider seeking regulatory approval for their products. According to reports by Deloitte and Ernst & Young, manufacturers can expect a significantly costlier route to compliance. Both Deloitte and Ernst & Young noted that the increased cost of compliance may force manufacturers to withdraw products or in some cases, put themselves up for sale. Fournier differs on this view.
‘No, I don’t think this will be the case. They (MDR) are not that drastically different from the previous directives. If you manufacture Class 2 or Class 3 devices, you will have to invest more but it won’t cost you millions to transition from the directives to the regulations. It will require more work but not significantly more. There will be an adaptation period but it won’t be such a burden that we won’t see new products and devices.’
Fournier is optimistic that the MDR won’t present too significant a challenge to manufacturers preparing for regulatory approval, as long as they understand what’s required of them.
‘There are three main things that I’d advice. The first is to plan well in advance. The second is to consider the notified bodies in transition planning because these bodies will be able to audit manufacturers from 2020. The third is to provide sufficient clinical data.’
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