In a major development for medical device manufacturers, the Parliament and Council of the European Union (EU) have approved a proposal by the European Commission to delay by one year the date of application of the provisions of its Medical Device Regulation ((EU) 2017/745).
The decision to delay the effective date of the MDR was prompted by the impact of the COVID-19 pandemic on healthcare institutions, medical device developers and regulatory authorities, and the Commission’s belief that stakeholders would not be able to properly implement and apply the MDR’s provision in the current environment.
However, there were a number of other considerations that made the original effective date of May 26, 2020 unrealistic. These include the continuing lag in the development of certain key standards and guidance documents, the incomplete state of the EUDAMED and UDI databases and, most important, the lack of a sufficient number of EU-approved Notified Bodies to conduct testing and to certify devices for compliance with the regulation. Regulation (EU) 2020/561, which delays the MDR date of application to May 26, 2021, took immediate effect upon its publication in the Official Journal of the European Union on April 24th.
