The pan-European industry association MedTech Europe has published four documents in recent days to assist device manufacturers navigate the coronavirus pandemic and the transition to compliance with the new regulations (MDR, 2017/745 and IVDR, 2017/746).
The statement relates to the potential for clinical investigations, including post-market clinical follow-up (PMCF) studies needed for recertification purposes, to be delayed because of the COVID-19 pandemic, explaining that: “medical device manufacturers are striving to keep clinical investigations for existing and new medical technologies running with minimal disruption while preserving the safety of the participants and the quality of the generated data. Despite the best efforts, some activities in the framework of clinical investigations may have to be delayed, slowed down or reduced. In view of this situation and its potential impact on recertification of medical devices joint efforts are needed from all stakeholders.”
The first guidance document is ‘Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union’, which is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the IVDR. The association comments that the publication is being put in the public domain so that manufacturers both within and outside of MedTech Europe membership can efficiently transition to the new regulation in an aligned and consistent manner.
The second guidance document is a Basic UDI-DI guidance, published for the benefit of all stakeholders involved in Basic UDI-DI assignment and assessment, such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies. The document describes the legal and other connected rules – mainly arising from the EUDAMED database design – that are essential to understand before making decisions on the Basic UDI-DI grouping.
The position paper is titled ‘Use of international generally acknowledged state-of-the-art standards in the absence of harmonised standards under the IVDR and MDR’, in which it provides a set of criteria that manufacturers can use in the absence of harmonised standards (Annexes I and II of the document).
The MDR and IVDR support the use of harmonised standards, however, given current progress, it is questionable that harmonised standards for the new regulatory framework will be available on time, especially by the date of application of the MDR (26 May 2021). The Commission and the Competent Authorities are working together with the European Standardisation Organisations to finalise the standardisation request, which is required for harmonisation to take place.
During this time of uncertainty and in the absence of harmonised standards, industry is concerned about inconsistent and possibly arbitrary approaches to the application of standards as a reference and benchmark for safety and performance, and MedTech Europe suggests that a possible solution is to apply the following ranking model: