Postponement of the application of the Medical Devices Regulation
The European Commission adopted a proposal to postpone the application date of the Medical Devices regulation by one year, to 26 May 2021. The postponement is supposed to give authorities, manufacturers and other actors more time to implement the regulation so they can deal with more pressing issues related to the COVID-19 Crisis.
The statement has been drafted with Prof. Alan Fraser (Chair of the Regulatory Affairs and Medical devices Taskforce) and Prof. Elizabeth Macintyre (Chair of the In Vitro Diagnostics Working Group and member of the BoD) and is endorsed by the Board of Directors.
Prof. P. Van den Bergh is EAN delegate to the BMA TF “Regulatory Affairs and Medical Devices. More on the TF Regulatory Affairs and Medical Devices can be found here.