Concerns grow over delays in implementation of the Regulations on Medical Devices

Less than two years out from full application of new-and-improved rules, stakeholders in the European medical device industry are getting nervous about the continuing holes in the regulatory edifice. Will the Commission be able to get everything in place in time, or is it about to botch the job?

Comprising almost 400 pages in total, the Regulations on Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) are symptomatic of the ‘Swiss Cheese’ approach that characterises EU law-making today. Despite the significant volume of legal provisions, many gaps remain to be filled, particularly via secondary legislation. With MDR and IVDR, the responsibility falls primarily on the Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, or ‘DG GROW’.

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