On 3 April, the European Commission adopted a proposal to postpone the application of the Medical Devices Regulation (MDR) by one year. Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April with a speeded-up process. The amending Regulation 2020/561 was published in the Official Journal of the European Union on 24 April and entered into force on its date of publication.
The original date of the MDR application – 26 May 2020 – was deferred for 12 months, to a new date of 26 May 2021. This also means that Medical Devices Directive will be repealed one year after the new date of application of the MDR. The adoption by the Parliament and Council also applies to active implantable medical devices. The postponement does not affect the date of application of the In-vitro Diagnostic Regulation, which is still 26 May 2022.
The cause for the postponement was the outbreak of the COVID-19 pandemic coupled with Brexit and lack of designated Notified Bodies. This causes pressure to the field of operation. The priority now is to supply safe and well-performing devices to patients, healthcare professionals and healthcare systems. Therefore, the manufacturing and auditing resources should be reserved to combat COVID-19 on the front line.
Please see the latest proposal version for MDR corrigendum here. The postponement will also impact national legislation complementing the Regulation.
There is still plenty to do when preparing for the new Medical Device Regulation. We are now being offered an opportunity to spend the additional time wisely and work with the remaining open implementation questions related to MDR guidance documents still under preparation, designation of Notified Bodies and so on. The additional time also enables the EU to update its Mutual Recognition Agreement with Switzerland and UK and its Customs Agreement with Turkey.
The Medfiles Medical Device Team is here to help you with any MDR-related tasks!
[one-half-first]
Anna Tirri
Regulatory affairs expert
Mob. +358 40 162 6330
[/one-half-first] [one-half]
Päivi Turta
Regulatory Affairs Manager
Mob. +358 50 313 0323
[/one-half]
