The European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation (MDR) to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.
This proposal therefore postpones the application of the EU Regulation by one year – until 26 May 2021.
What does this mean for UK dental laboratories?
The UK MDR (which generally mirrors the EU MDR) is due to be effective from 31 December 2020, which is the day the UK is currently set to exit the EU. Therefore, as it currently stands, the UK MDR (which includes all the new updates) will come into effect prior to the postponed EU MDR and as such compliance will likely be required by UK dental laboratories by this exit date.
The MHRA have made the following announcement regarding the postponement:
As stated in the MHRA guidance, all dental laboratories should continue to comply with the existing regulatory requirements of the current Medical Devices Directive (MDD).
For any dental laboratories that have already implemented all the required changes for the new MDR you can continue running the new requirements.
The DLA will continue to update all members when further information is published regarding the UK’s date for implementation of the MDR.