Fabien Roy

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...