MHRA update on CE mark recognition for medical devices
16 March 2021
Following discussions at recent meetings between MHRA and fellow trade associations, the regulator has provided clarification on how the period of CE mark recognition will operate in cases where a medical device is also subject to another set of regulatory requirements with a different recognition period.
The MHRA has stated:
In certain cases, medical devices are subject to multiple pieces of product legislation. The period for acceptance of the CE marking (known as the ‘standstill period’) for medical devices in Great Britain runs until 30 June 2023, after which time the device will need to be UKCA marked.
However, in other areas, the standstill period differs in length and a UKCA mark will be required before this date. For example, certain product areas, listed here, will require the UKCA marking from 1 January 2022.
Where products are subject to more than one standstill period, the longer standstill period will apply.
This means, where a medical device must also comply with other legislative requirements (such as the restriction of hazardous substances), the longer medical devices standstill period will apply. Therefore, you can continue to CE mark your medical device until 30 June 2023, and you only need to apply a single CE mark to the device to meet all of the relevant requirements.
