News Category: Regulatory news
On 17 April, the European Parliament adopted, by urgent procedure, the European Commission's proposal to postpone the implementation of the Medical Devices Regulation (MDR) 2017/745 by 12 months.
The amending Regulation will be published in the Official Journal of the European Union (OJEU) shortly and will enter into force on the date of publication. As a result, the date of application of the MDR 2017/745 is now 26 May 2021.
The results of plenary sessions will be published on the European Parliament website in due course. See also the OJEU website.
The HPRA will continue to work closely with stakeholders during these additional 12 months to ensure the MDR is implemented effectively.