The new regulations for medical devices in the UK may prove to be a challenge for manufacturers in bringing devices to the market.
In a recent poll Verdict has conducted to assess the impact of Brexit transaction on the UK’s ability to acquire the latest and safest medical devices, a majority 50% of the respondents opined that the ability will be affected.
Approximately 34% of the respondents opined that Brexit will not impact the acquisition of medical devices, while 19% voted that they do not know about the impact of Brexit transaction on the acquisition of medical devices.
The analysis is based on 218 responses received from the readers of Medical Device Network, a Verdict network site, between 07 December 2020 and 01 February 2021.
Brexit impact on medical devices in the UK
Medical devices will need to apply for UK Conformity Assessed (UKCA) mark, under the new trade agreement signed between the UK and the European Union (EU) following Brexit. Although the CE mark will be accepted until June 2023, the UKCA will be required to market products in England, Scotland, and Wales.
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The new regulations may impact the number of medical devices that are eligible for approval leading to a decline in volume of devices being approved in the UK. These devices may still be approved and marketed, but will take more time to reach the market.
Furthermore, it will lead to increase in marketing cost for medical device manufacturers in the UK and EU markets.