Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission, Parliament and EU Member States to extend the transition period under the Medical Devices Regulations (the MDR and the IVDR). As mentioned in one of our earlier blogs, the MDR and IVDR are due to take effect on 26 May 2020 and 26 May 2022 respectively. The position paper explains that the medical technology industry has “significant concerns” about the state of implementation of the Regulations, and the fact that if products are not re-certified before the date of application of the Regulations, they will not be able to be placed on the market, and the industry will be unable to provide life-saving and life-transforming products to patients.
The position paper is critical of the slow progress of the authorities in putting in place the infrastructure that will enable the new regulatory systems to operate, such as:
- Notified Bodies: these bodies must be re-designated before they can assess and re-certify medical devices and in vitro diagnostics in accordance with the Regulations. There are no grandfathering provisions under the Regulations, so all products currently on the market need to be re-assessed. There are also increased obligations on notified bodies, and more products that require the involvement of a notified body before being placed on the market. We understand that as of May 2018, out of 59 existing notified bodies, only 20-30 had applied for re-designation, and that the assessment process lasts approximately 18 months. Industry is also concerned about the current resources available to notified bodies to deal with the increased workload under the Regulations.
- Implementing acts: as explained in one of our earlier blogs, before the Regulations can take effect, a number of implementing acts must be put in place. To date, only 2 of the 18 mandatory implementing acts have been published. As such, there are many parts of the framework that are still not clear.
- Expert panels: certain new products and high-risk devices must be reviewed by an expert panel before they can be CE marked. The industry is concerned that the expert panels, reference laboratories and common specifications, on which these CE markings depend, will not be established in sufficient time.
- Standards and Guidelines: these are necessary for the industry to devise a common interpretation of how to correctly apply the new Regulations, but they are not yet in place.
- Eudamed: there are concerns that the European Database on Medical Devices (Eudamed), which aims to facilitate information exchange about medical devices, will not be ready in time. It is thought that this could impair market surveillance and transparency, thus undermining the uniform application of the Regulations.
The position paper notes that, currently, between 30-40% of medical technologies in the EU are certified in the UK, meaning a UK notified body has undertaken the conformity assessment procedure. Given the uncertainty around Brexit, it is unclear if these notified bodies will continue to operate within the EU-framework after March 2019, or if their capacity will need to be transferred to an EU-based notified body. Although most UK notified bodies have now established a base in the EU27, questions remain about the validity of certificates currently certified in the UK.
Suggestions from MedTech Europe
Until 26 May 2024, certain categories of medical devices, which were certified under the Directives, can benefit from a ‘grace period’. This means that if their certificates are renewed before May 2020 (or May 2022 for IVDs), they can remain on the market beyond the end of the transition period, until their certificates expire. The industry has concerns that this will significantly increase the demand for certificate renewals under the Directives, adding to the already mounting workload of the re-certification procedure under the Regulations. Further, the ‘grace period’ does not apply to certain categories of products, for example products that now require the involvement of a notified body as part of the conformity assessment procedure.
Given these concerns and ongoing delays, MedTech Europe calls on the European Commission, European Parliament and all EU Member States to have an urgent discussion about possible solutions to rapidly install the functionality of the new regulatory systems. In relation to the transition periods, the industry has called for:
- a ‘stop the clock’ mechanism, which would freeze the remaining transition period until the system is fully ready; or
- an extension to the dates that the Regulations take effect, either for all products, or legacy products only; and
- an extension to the scope of the ‘grace period’ to include all products, and particularly legacy products, or for the timings to be made more flexible.
At the time of writing, the EU institutions have not responded to MedTech’s call for action. However, members of the European Parliament Committee on Environment, Public Health and Food Safety (ENVI) have also raised questions with the Commission about the steps it is taking to make sure the MDR and IVDR will be ready in time.