The UK is one of the biggest markets for medical devices in Europe and the world. Verdict fielded a poll to assess the impact of Brexit on the marketing of medical devices in the UK after the Brexit transition.
Marketing of devices is expected to be more difficult in post-Brexit UK as opined by a majority 60% of the respondents.
Approximately 20% of the respondents felt that the transition would make the marketing easier, while another 20% voted that they do not know about the impact of Brexit transition on the marketing of medical devices.
The analysis is based on 220 responses received from the readers of Medical Device Network, a Verdict network site, between 07 December 2020 and 25 January 2021.
New rules introduced for medical devices in the UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the medical devices following Brexit. The regulation applies to Great Britain including England, Wales and Scotland, although different rules apply to Northern Ireland.
Some of the changes include continuation of CE marking and certificates issued by EU-recognised Notified Bodies till 30 June 2023. A new mark called the UKCA (UK Conformity Assessed) is being issued on all devices in the UK from 01 January 2021. Further, the European Union (EU) will not recognise UK Notified Bodies and will not issue CE certificates, hence a new registration route for all medical devices from the UK is being adopted.
All manufacturers will first need to register with the MHRA and require vigilance reports to be submitted to the agency. Approval and marketing of the products is expected to become complex and lengthier as manufacturers will need to comply with the regulations of both the EU and the UK, according Noerr Consulting.