MDR transitional provisions
This webpage provides practical information for stakeholders about the transitional provisions outlined in the Medical Devices Regulation (MDR).
What are transitional provisions?
To support the supply of medical devices to the EU market, Articles 120 and 123 of the MDR set out transitional provisions.
These provisions give more time to manufacturers of some devices already placed on the market to comply with the MDR.
When do transitional provisions apply?
On 26 May 2021, the MDR replaced the medical devices directive (MDD) and the active implantable medical devices directive (AIMDD).
Transitional provisions may apply to devices CE marked in line with the MDD or AIMDD. These provisions only apply if there are no significant changes in the design and intended purpose of the devices.
These provisions may also apply to class I devices ‘up classified’ under the MDR if the manufacturer draws up declaration of conformity before 26 May 2021.
Article 122 of the MDR calls out exceptions to some key provisions relating to Eudamed.
Do MDR requirements apply to devices subject to transitional provisions?
MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices fully apply to devices subject to transitional provisions.
The reporting of serious adverse events and device deficiencies observed during clinical investigations must be carried out in line with the MDR.
When do I need to place a UDI carrier on my medical device?
Article 27(4) notes that manufacturers must place UDI carriers on the label of devices and on all higher levels of packaging.
Article 123 of the MDR sets out a number of soft provisions which cover the phased application of device labelling and UDI carriers.
Separate timelines will apply for reusable devices required to bear the UDI carrier on the device itself. We have provided a summary of UDI timelines in the table below.
For more details about MDR transitional provisions, please go to the MDCG’s homepage.