In the event that the UK leaves the EU in a ‘no-deal’ scenario at the end of October this year, UK Notified Bodies will lose their designation under the Medical Device Directives. As a result, UL International has taken the decision to cease operation as a notified body, effective from September of this year. UL has stated that it has transferred 80% of its CE Mark customers to Polish notified body Polskie Centrum Badan I Certyfikacji (PCBC) and the remainder to another EU27 Notified Body.
This news comes shortly after the announcement in June by Notified Body Lloyd’s Register Quality Assurance (LRQA), that it would be withdrawing services. This was a decision that was reached following the discovery that it would take until 2020 to set up as a Dutch notified body. The timeline means that Lloyd’s customers risk losing access to the EU market if the UK leaves the EU without a deal.
According to MedTech Europe, UK-based notified bodies are responsible for up to 30% of CE marks. The loss of some of the notified body capacity in the UK comes at a time when there are increasing concerns about whether there is a sufficient number of notified bodies to meet the demand created by the upcoming EU regulation: the Medical Devices Directive and the In-Vitro Diagnostic Devices Directive.