As of 1 January, 2021 new relationships between the UK and the EU came into force. Among others this will impact the medtech industry with new requirements for market access and device registration.

Meditrial offers market access and regulatory solutions for devices manufacturers. The Meditrial dedicated team of experts will help you to be compliant with new requirements and ensure market approval for your device. Contact us today!

• UKCA marking replacing CE marking:

The UKCA (UK Conformity Assessed) marking will be the UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland) as of January 1st 2021. Find more info about the application timeline here.

The UKCA marking will apply to most products which previously required the CE marking, including medical devices and IVDs. The UKCA will not be recognized on the EU market. Products that require CE marking will still need a CE marking to be sold in the EU.

However:

• CE marking will continue to be used and recognized in Great Britain until 30 June 2023
• Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023

If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK.

Learn more about Meditrial Market Access Services.

• Approved bodies for medical devices in the UK:

The MHRA has issued a guidance to outline the legislation regulating medical devices, the requirements to become an approved body, their roles as well as a list of currently approved bodies.

Current approved bodies in the UK as of 4 January, 2021:

BSI Assurance UK Ltd.
SGS United Kingdom Ltd.
UL International (UK) Ltd.

For more details, please see the guidance from the MHRA.