EU Proposes Extension to 2021 for New Medical Device Regulations

In the next few days, the European Commission is to present its Parliament a proposal to delay the European Union’s new Medical Device Regulations (MDR) application date scheduled for the end of May 2020. This proposal of a postponement by one year would allow medtech companies, amongst other concerned actors in the industry to prioritize their efforts in tackling the evolving challenges presented by the Covid-19 pandemic.

The new European MDR was approved in April 2017 with a mandatory compliance by May 26, 2020 for medical device companies who wish to sell their product in the European market. The new set of rules comes to replace its Directive previously in place for almost 25 years and aims to increase patient safety through an improved control of the production and distribution of medical devices in Europe. The implications for medical device companies are significant. Among them are major changes to the CE mark approval process with a revision of all class types of medical devices, reinforced requirements for clinical evaluations and trials and additional requirements for medical products labeling and traceability. Compliance with these new regulations requires considerable preparation and cost allocation efforts from medical device companies.

Questions have been raised in the past year on whether companies and competent authorities would be ready by the May 26, 2020 application deadline, and the COVID-19 pandemic is likely to further strain company and regulatory resources. To that end, the proposed extension to 2021 would be a positive development for companies, enabling the industry on a global scale to mobilize its resources to address these challenges and prepare adequately for a return to a stable environment.