The application data of the Medical Devices Regulation (MDR) EU 2017/745 has been officially postponed, such as instituted by the EU Parliament vote on 17th April 2020.
On the end of March, the European Commission announced a proposal to postpone the application of the regulation, which was then announced in early April. The 693 votes in favour of EU parliamentarians last week made official the postponement, with only one opposite and two abstentions. Currently, the approval of the Member States and publication in the Official Journal are still pending, which however should arrive in early May.
The expiration of the MDR is therefore postponed for one year, from 26th May 2020 to 26th May 2021. The expiry date for in vitro medical devices, scheduled for 26th May 2022, remains unchanged.
The changes introduced by the regulation mainly concern the expansion of the concept of medical devices with the review of the relative risk classes, the improvement of the safety of the devices and the more rigorous control by the Notified Bodies, by the European Commission and by the National Competent Authorities.
Manufacturers, among other things, are required to have quality and risk management systems, to conduct clinical assessments, to compile a technical documentation that allows their compliance and to apply a procedure of EU conformity assessment for the affixing the CE marking. The real new for them, however, will consist in the implementation of the UDI (Unique device identifier), defined by the regulation as “a series of numeric or alphanumeric characters created on the basis of device identification and internationally accepted coding rules that it considers the unequivocal identification of specific devices on the market “.
There will be many news and considering the delays in the Regulation applying process accumulated by the various stakeholders and the currently pandemic in progress, it has been considered that this is not the best moment to apply the new regulation. Health Authorities and manufacturers now have to fully focus on the fight against Covid-19 and to face the change brought by the MDR with the necessary attention in a secondary moment.