The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes.
However, with these two regulations coming into force by May 2020 (for medical devices) and May 2022 (for IVDs), I sense a growing concern from manufacturers. The immediate worry is about keeping existing products on the market and there is growing unease about how to ensure new products reach patients efficiently.
As you may know, medical technologies must carry a CE mark if they are to be marketed in Europe. This well-established and highly recognisable logo carries significant weight and is trusted by consumers.
CE marks for medical devices and diagnostics are issued by Notified Bodies – a vital component in the regulatory machinery. The challenge facing medtech is that the new regulations introduce additional responsibilities for Notified Bodies, requiring them to do much more work than before.
For example, under the current Directive, between 80% and 90% of IVDs do not need approval by Notified Bodies. Under the new rules, this will reverse: the majority of diagnostics manufacturers will need to engage with NBs. This will mean 35,000 IVDs will be covered by Notified Bodies for the first time.
The problem I see with this is that Notified Bodies will, under the changed rules, be subject to increased oversight by Competent Authorities. In short, they need to meet more stringent requirements than in the past if they are to be recognised.
Today, there is just one Notified Body designated under the Medical Devices Regulation – the BSI based in the UK – and just 36 others have submitted applications to the European Commission. Not all of those that have applied for designation intend to handle as many product types in future as they do today. Manufacturers need to know what their Notified Body will deal with in future in case it means that they need to find a new one.
Brexit also poses new challenges. Up to 30% of the medtech industry’s products have been authorised via UK Notified Bodies and could lose such authorisation overnight in the case of a ‘cliff edge’ Brexit. Even in the case of an orderly withdrawal of the UK from the EU, the future relationship between the UK and EU – and the implications of this for Notified Body capacity – are unclear.
In short, all of this means we will have fewer Notified Bodies doing more work.
To me, the enemy here is time. It is critical that we have more Notified Bodies designated as soon as possible so that manufacturers can begin working with them immediately on conformity assessments for their products.
Some products covered under the existing Directive will benefit from the ‘soft transition period’ for as long as their certificate of conformity is valid. This means they can still place these products on the market. However, not all devices benefit from the transition. For example, if a manufacturer has a product which is a Class I device under the current Directive but becomes a Class IIa device under the Regulation, they will suddenly need a certificate of conformity. The implication is that they do not benefit from a transition – the May 2020 deadline for them is very real. All of this brings unwelcome uncertainty to the system, especially for smaller companies.
We need more Notified Body capacity and full scope coverage so that manufacturers can begin working on CE marking some of their products under the new Regulation. The European Commission and Member States must also deliver guidance documents and implementing legislation as soon as possible. You can only transition when you know the rules.
My advice to manufacturers is to engage with their Notified Body without delay: CE-marking is a process, not an event. Be proactive; find out where they are in the designation process and where they plan to work on all product types. Waiting is not an option – act now.
This blog is part of the MedTech Forum blog series. Fabien Roy will be speaking at the MedTech Forum. You can follow the conversation under #MTF2019 and find more details at medtechforum.eu.