News Category: Regulatory news
The Medical Device Regulation (MDR) was due to become fully applicable on 26 May 2020. However, the outbreak of COVID-19 has placed unprecedented and unexpected pressures on economic operators, notified bodies and competent authorities.
With the above in mind, and the acknowledgement that patient health and safety are central to the work of the MedTech sector, the European Commission announced on 25 March 2020 that work on a proposal to postpone the application date of MDR for one year is ongoing. The Commission aims to submit this proposal in early April to the Parliament and Council for adoption before the end of May.
This proposal will allow competent authorities, notified bodies, manufacturers and other stakeholders to focus fully on urgent priorities related to the COVID-19 outbreak.
Further information on the Commission’s announcement can be found here.