EU finalizes one-year MDR application delay.
On April 24th, Regulation 2020/561 has been published in the Official Journal of the European Union, postponing of one-year the date of application of the EU Medical Device Regulation (EU 2017/745) and extending the Medical Device Directives transitional period.
Council and the European Parliament has adopted the European Commission proposal with the Regulation 2020/561, amending the Regulation EU 2017/745, that extents the transitional period of MDR by one year, until May 26th 2021.
Despite of that, it’s important to note that the deadline for validity of MDD CE certificates remain fixed on 26 May 2024.
The exceptional measure has been generated by the COVID-19 outbreak that may have had a negative impact on various areas covered by Regulation (EU) 2017/745, such as availability on the market of medical devices vitally important in the context of the COVID-19 as well as the designation of Notified Bodies.
In light of above, in order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety and to avoid potential market disruption, the EU Regulation 2020/561 has been entering into to force the same day of publication.
This postponement takes the burden off for National Authorities, Health Institutions, Notified Bodies and Economic operators actively involved to recruit a greater amount of resources due to the Covid-19 pandemic.
In addition to that, the delay of transitional period aims to avoid the shortage of essential medical devices on the market as well as to allow Notified Bodies and Economic Operators to complete the implementation of MDR timely fashion and adequately.
Read the REGULATION (EU) 2020/561 HERE.