Dive Brief:

• UL International will stop operating as a U.K. medical device notified body and severely limit its in vitro diagnostic activities from September onward.

• The notified body is stepping back from the U.K. device and IVD sector in response to the risk of a no-deal Brexit, which it said would cause it to lose its designations under European Union laws.

• UL said it has partnered with a Polish notified body and transferred CE certificates to it to mitigate the impact of its decision on customers.

Dive Insight:

The pool of U.K. notified bodies is shrinking quickly. Lloyd's Register Quality Assurance said it would withdraw last month, shortly after learning it would take until 2020 to set up as a Dutch notified body. The timeline means Lloyd's customers risk losing access to the EU market if the U.K. leaves without a deal at the end of October. The two candidates competing to be the next leader of the U.K. have said they are willing to leave without a deal.

Weeks after Lloyd's revealed its plans, UL has unveiled a similar strategy. As of Sept. 1, UL will cease to serve as a notified body under the outgoing device rules. UL will also limit its IVD activities to one NBOG code that covers tests for certain chromosomal disorders, such as Down syndrome. Today, UL's designation covers more than 20 NBOG codes.

UL has partnered with a Polish notified body, Polskie Centrum Badan I Certyfikacji (PCBC), to insulate its customers from the effects of its decision. PCBC has already taken ownership of 80% of the CE mark certificates held by UL. The other 20% of certificates have gone to another EU notified body, UL said in its notice.

The transfer means UL's customers are protected from some of the near-term supply problems that may arise in the event of a no-deal Brexit. However, in the longer term there could be downsides to the loss of another U.K. notified body.

U.K.-based notified bodies are responsible for up to 30% of CE marks, according to MedTech Europe. The loss of some of the capacity that turned the U.K. into a cornerstone of the market comes at a time when there are significant concerns about whether there are enough notified bodies to meet the demand created by the incoming EU rules on medical devices and IVDs. 

One U.K. notified body, BSI, has secured designation under the incoming device rules and opened an office in the Netherlands to mitigate the risk of a no-deal Brexit. The second remaining U.K. notified body, SGS, also has offices designated under the outgoing device rules in other European countries.

UL is an international company but none of its other European offices are currently designated under either the outgoing or incoming medical device and IVD rules.