The European Medical Device Regulation (EU MDR) will come into effect on 26th May 2021, a year later than originally planned.
The main reason for this postponement is to allow manufacturers to focus on tackling the Covid-19 pandemic.
Previously, the European Commission voted 693-0 to adopt the amendment to delay EU MDR by one year. This delay was made official on Friday 24th April, with the publication of an amendment in the Official Journal of the European Union.
Stella Kyriakides, European commissioner for health and food safety, commented on the news: “[Wednesday’s] adoption will allow us all, in this time of crisis, to maintain our focus on the most critical issues and to ensure the continued availability of vitally important medical devices.”
MedTech Europe, who had previously asked the European Commission to consider a delay for EU MDR implementation, also welcomed the news, stating: “The amendment will allow the medical device industry to maintain maximum focus on helping healthcare systems to combat Covid-19, and on addressing the pandemic’s impact on the whole healthcare ecosystem.”
It is worth noting, however, that the In Vitro Diagnostic Regulation (IVDR) is still planned to take effect on 26th May 2022. MedTech Europe believe this timeline needs to be postponed: “MedTech Europe strongly believes that the transition timeline needs to be adapted by at least 12 months, both to address today’s reality and to prevent unintended fall out in the future.”