UL International (UK) (NB 0843) has taken the decision to cease operation as a Notified Body under the Council Directive, 93/42/EEC concerning medical devices (MDD). This will be effective from 1 September 2019. A press release notes this decision is in response to a potential “no deal” Brexit, explaining that a “no deal” will lead to UK Notified Bodies losing their designation under the MDD.
The press release adds that, under Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), UL has taken the decision to restrict its designation as a Notified Body. Under the IVDD, UL will be limiting its scope under the IVDD to a single NBOG code, IVD 0308 (Risk of trisomy 21 (incl. software)). This means that effective from September, UL will only hold designation to IVD 0308 under the IVDD.
UL has formed a partnership with Polish Notified body, Polskie Centrum Badan I Certyfikacji S.A. (PCBC, NB 1434). Through this partnership, UL customers will be transferring their UL CE certificates across to PCBC. This will ensure that UL’s Notified Body customers will have continuous certification to enable them to continue to place products on the market and allow continued patient access to these devices.
As at the time of the posting of this notice, UL has transferred over 80% of CE certificates to PCBC. The remainder have transferred to another EU27 Notified Body.