UK Medical Device Regulations (including IVDs)

As of 1st January 2021, the UK has now left the European Union. 

For the UK IVD market, IVD devices will need to comply with the new UKCA mark from 2023. Manufacturers who are not based in the UK, will need to appoint a UK Responsible Person (UKRP), which is broadly equivalent to the EU Authorised Representative to continue placing devices on the UK market.

UK Transitional Timelines:

30 June 2025 - New devices placed on the market after this date will have to meet the new UKCA marking requirements. 

30 June 2030 - If the devices already have a CE mark, they can continue to be placed on the UK market with this CE mark, this is subject to the IVDD/IVDR transitional arrangements of the EU. Beyond this date, all devices are required to meet the UKCA marking requirements.

The UK regulations are expected to be published in 2023/2024,  follow us on LinkedIn, to get updates as they come in.

*Gov.uk update* Latest update reflects the 12-month standstill extension for the new UKCA regime for medical devices.
It confirms that CE marked devices can continue to be placed on the UK market until 1 July 2024, and devices placed on the market after this date will be subject to the transitional arrangements.

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European In Vitro Diagnostic Regulation (IVDR)

The regulatory environment for IVDs in the European Union is undergoing a period of significant and continuous change which can be overwhelming and sometimes daunting. 

One of our biggest missions here at IVDeology is to provide support to those transitioning with the changes, to continue to be legally and safely manufacturing and distributing safe IVD products as easily as possible.  This means that IVD manufacturers, importers and distributors need to be vigilant and responsive to the changes. 

This remains a big challenge for the industry but with patience, focus and time, can be managed and implemented safely.

EU IVDR (2017/746/EU) Transition Deadlines:

Class A - 26 May 2022

Class D - 26 May 2025

Class C - 26 May 2026

Class B, A Sterile - 26 May 2027

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