Europe Editor

BRUSSELS, Belgium — The annual MedTech Forum is organized jointly by the European Diagnostics Manufacturers Association (EDMA; Brussels) and the European Medical Technology Industry Association (Eucomed; Brussels). In a session titled "MDD Revision Unplugged: How close are we?" Roland Gérard presented the position of the industry associations concerning the proposed revision of the European Union's Medical Device Directive that governs the processes leading to a conformité européen (CE) mark that allows products to be commercialized in the Union.

Gérard is the Chair of the Eucomed Regulatory Affairs Committee and Vice President for Regulatory Affairs and Quality Assurance with the International Division of St. Jude Medical (St. Paul, Minnesota). Medical Device Daily attended the MedTech Forum and presents the transcript of his presentation.

Roland Gérard: Today it is premature to do an impact assessment of the revisions of the directive as there are too many unknowns in the regulation. What we are doing at this moment is informing top management about what could be the future impact and to prepare them for the worst case scenario. Looking at the proposed revisions today, there is no doubt we will need to increase regulatory resources. There will be more requirements for clinical investigation, so more resources will be needed and there will be greater expense for such investigations, in general. It will take longer to get a CE mark, especially if the "scrutiny process" is established in a pre-market phase.

At St. Jude Medical we are mainly concerned with Class III medical devices, with Class III implantable devices and with active implantable medical devices. We are watching very closely developments with regard to the scrutiny process, the definition of clinical efficacy that is being drafted right now, the application of the principle of equivalence, which may lead to more clinical investigation, and the reuse of single-use devices.

We have a lot of products for which the life cycle is about 18 months, so we really need a regulatory system that is adapted to this time frame. We hope we will not end up with a very burdensome system as they have in China, which results in approvals of old generation devices.

That is the summary of preparation. As a big company, for sure we will cope with new regulation. But I am very concerned for the small companies, the number of resources they will need to add is quite significant, along with the expense. So I would really challenge whether we need a scrutiny process. We have already seen a lot of change with the decision taken by the Parliament and the Member States as a result of the PIP scandal [Poly Implant Prothèse, La Seyne-sur-Mer, France; MDD, Oct. 3, 2012]. Member States are much more pro-active in post-market surveillance. And we now have audits by regulatory authorities, which is a first. So at present both the Notified Bodies and the authorities take their jobs very seriously. Why not continue to strengthen this area? Why not assess the capabilities for the assessment of clinical evidence within the notified bodies? Why not say that the authorities have a role to play in the designation of the expert within the Notified Bodies? If we achieve these things, I believe it will resolve most of the problems and we would not need either a pre- or post-market scrutiny process.

Predictability for industry is paramount. We need to know that if there is a scrutiny process, then which devices are going to be subject to scrutiny. What will be the process? How much time will it take? We do not want to have a lottery where maybe our device will be subject to a scrutiny. It is paramount to foresee what the requirements will be, we need to have a possibility to consult clinical experts, to know the requirements for very innovative technologies. If we have these and everyone commits to the suggestion, there will be no surprise in receiving the CE marking. The worst that could happen for industry is to receive a CE mark and a few months later it is withdrawn.

As a representative of industry, I would like to state that we fully support the revision of the legislation. We do think there is a need to improve legislation and strengthen some of the requirements. But we do not forget that the European model is one of the most efficient in the world and that with some fine tuning it could remain the reference model in the world. We should resist creating a very burdensome system, very administrative and lengthy that will not bring value to patient safety.

Many of our products are iterations of existing products that are made to improve safety and performance. If there is a lengthy process to get these iterations approved, it will be a pity, because the devices patients will receive will be less performing and less safe.

Published: October 21, 2014