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UKCA: UL Solutions Expands Scope For In Vitro Diagnostics

UL International (UK) Ltd. has recently expanded its Approved Body scope for IVD medical devices to cover the majority of IVD medical device codes.

Scientist pipetting samples into tubes.

January 23, 2023

In its continuous effort to address the emerging needs of connected medical device manufacturers in the United Kingdom and Northern Europe, UL International (UK) Ltd. has recently expanded its Approved Body scope for in vitro diagnostic (IVD) medical devices to cover the majority of IVD medical device codes.

Since Jan. 1, 2021, a new route to market and product marking, the U.K. Conformity Assessed (UKCA) marking has been available for manufacturers wishing to place medical devices on the U.K. market.

Third-party conformity assessment requires a U.K. Approved Body. UL International (UK) Ltd. can conduct conformity assessments concerning the UKCA marking for in vitro diagnostic medical devices under Part IV of the U.K. Medical Device Registration (MDR) 2002.

As of July 2024, a UKCA marking will be required to place a device on the U.K. market. UL Solutions can work in partnership with your current European Union (EU) notified body to support UKCA application processing.

Benefits to UL Solutions customers

The UL International (UK) Ltd. expanded IVD scope will help provide IVD manufacturers with an increased pathway to UKCA marking. Customers can now take full advantage of our capabilities, beat the queue and apply for conformity assessment evaluation to obtain a UKCA certificate before the date of application of the new U.K. MDR legislation.

UKCA certificates are valid for five years (subject to transitional arrangements).

Contact UL Solutions to register for your conformity assessment and talk with one of our experts for help achieving your compliance goals for IVD products.