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UK Government Introduces Legislation Setting Timelines for CE-Marked IVDs

NEW YORK – The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.

In the area of IVDs, the introduced legislation includes timelines for when CE-marked tests can be marketed and sold in Great Britain. IVDs compliant with the new In Vitro Diagnostics Regulation (IVDR), which is currently being implemented in the European Union, can be marketed and sold in Great Britain until the expiration of their CE certificate or June 30, 2030, whichever comes first.

General IVDs that are compliant with the IVDR can also be placed in Great Britain until June 30, 2030.

Meanwhile, class I medical devices and general IVDs that did not require assessment by a notified body under the old regulatory framework in the EU, the In Vitro Diagnostic Directive, can be marketed and sold in Great Britain only if a notified body assessment is required under the new IVDR.

Class I medical devices are those that pose no public health risk or low personal risk.

The UK is currently developing a new regulatory framework for the marketing and sale of IVDs, a process that has been delayed as the government seeks feedback from stakeholders and as there is a lack of notified bodies to certify test makers under the IVDR.

Last June, the UK decided to allow devices with CE-IVD marks to stay on the market until the expiration of the CE certificate or June 30, 2030. That decision has now been formally introduced as legislation. After those dates, all tests will need to receive the UK Conformity Assessed mark, a certification mark given by an approved standards organization, called an approved body, designated to assess IVDs in the UK.