Brexit in a Nutshell: Regulatory Aspects and Legal Implications

 

Webinar AssICC – 14 Aprile 2021

Topic of the webinar was the Post-Brexit situation and how to place medical devices on the UK market.

Since leaving the European Union, Great Britain has introduced some changes concerning the placing of medical devices on the UK market. On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union.

Manufacturer that would like to place a medical device on the United Kingdom (UK) marketplace must put in charge a reliable and professional UK Responsible Person, checkup existing EU CPNP notification and download them in view of upcoming UK SCPN portal, check availability and compliance of EU-PIF: upgrade them to UK new rules.

Until 30 June 2023, the CE mark will continue to be recognized in Great Britain. CE marked devices and certificates issued by EU recognized notified bodies in accordance with applicable legislation (Directive 90/385/EEC, Directive 93/42/EEC, Directive 98/79/EC, Regulation 2017/745, and Regulation 2017/746) will continue to be accepted until 30 June 2023.

From 1 July 2023, the UKCA (UK Conformity Assessed) mark will be required to place a device on the UK market. Products will therefore have to comply with UKCA marking requirements.

 

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