07 August 2018 - Authored by:Jacqueline Bore
MedTech Europe, the European trade association representing the medical technology industries, has called on the European Commission, European Parliament and EU member states to allow more time for the implementation of the changes to the regulatory scheme for medical devices brought about by the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), which apply from May 2020 and May 2022 respectively.
The new Regulations provide for a three year transition period for changes to the regulatory landscape for medical devices and a five year transition period for in vitro diagnostics (see the previous update in our “Getting ready for the EU MDR” series: “Timelines for manufacturers“). In its policy paper published on 6 August 2018, MedTech Europe argues that progress has been very slow in setting up the systems necessary to ensure that the industry can continue to operate seamlessly once the transitional periods end. For example, only 2 out of the 18 Implementing Acts have so far been published by the European Commission. Expert Panels, Reference Laboratories and Common Specifications that are essential for certain new and high risk devices to be CE marked have yet to finalised. The industry also needs to see a complete set of standards and guidelines developed to provide a common interpretation to the application of the new Regulations. Work on the new database designed to strengthen market surveillance, Eudamed, seems to be behind schedule. MedTech makes the point that industry is depending on all of these elements being in place well before the deadlines for implementation in order to be able to certify or re-certify products under the new Regulations on time.
The industry’s greatest fear is that the Notified Body system will not have sufficient capacity and expertise to manage the workload involved in implementing the changes that the Regulations require (see the previous update in our “Getting ready for the EU MDR” series: “New obligations for Notified Bodies“). In addition to having to certify or re-certifying increased numbers of medical devices and in vitro diagnostics, Notified Bodies are to have new obligations in relation to the analysis of clinical benefit assessment. There is concern that Notified Bodies do not yet have access to sufficient expertise to carry out these tasks. The Notified Bodies themselves need to be re-designated and this itself can take on average 18 months.
Brexit is creating an additional headache as currently 30-40% of medical technologies in the EU are certified by UK Notified Bodies. As things stand at in the Brexit negotiations, all of the work of the UK Notified Bodies will need to be absorbed by Notified Bodies established in the EU-27 (see the previous update in our “Getting ready for the EU MDR” series: “Brexit and the medical devices industry: copying with uncertainty“).
MedTech Europe does not see the grace period built into both Regulations as the solution to avoiding the bottlenecks it has identified. It believes the demands on the services of Notified Bodies will simply be too great. The grace period does not, in any event, apply to product categories that need Notified Body certification for the first time.
The trade association is, therefore, calling on the EU institutions to adopt solutions to ensure that the new system for the regulation of medical devices is functional in good time. Such solutions could include extending the May 2020 and May 2022 deadlines for implementation for the Medical Devices Regulation and the In Vitro Diagnostics Regulation respectively, either for all products or simply for legacy products. Another option would be to stop the clock on transitional arrangements until full readiness of the systems can be demonstrated. Adaptations of the grace period to include legacy products, for example, or simply to extend its timing could also be considered.
The industry is so concerned about the threat to continuity of care of patients by the lack of readiness of the new systems that its call to action is stated in the strongest possible terms. The arguments for more time are powerful ones that will be difficult for the EU institutions to ignore.