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UL UK to Sunset Operations Under EU’s Medical Device Directive

Posted 08 July 2019 | By Ana Mulero 

UL UK to Sunset Operations Under EU’s Medical Device Directive

UL UK says it will no longer operate as a notified body (NB) under the EU’s medical device directive (MDD) and limit its work under the in vitro diagnostic directive (IVDD).
 
From 1 September, UL UK will no longer operate under MDD and its current IVDD scope will become limited to a single Notified Body Operations Group code because of the implications of a no-deal Brexit.
 
All UK NBs are set to lose their designation status in the event of a no-deal Brexit. Stewart Eisenhart, senior regulatory analyst at UL Health and Life Sciences, told Focus on Monday that "the outcome of Brexit remains unclear, but preparing for a no-deal withdrawal and partnering with a European-based NB best serves our medical device and IVD clients whose MDD and IVDD certifications must be maintained."
 
UL UK’s IVDD operation will be limited to just IVD 0308 or Risk of trisomy 21 (incl. software) from 1 September, which will be a decrease from 26 product families its designation currently covers. The NB explains that it forged a partnership with Poland-based NB Polskie Centrum Badan I Certyfikacji S.A. (PCBC) to transfer CE certificates issued under MDD/IVDD.

UL UK adds that more than 80% of its CE certificates had been transferred to PCBC as of 3 July.  "Certificate transfers to our partner NB in Europe, PCBC, ensures that the impact of a no-deal Brexit does not invalidate their certifications and allows them to maintain supplies to EU patients and health care providers," said Eisenhart. "UL clients were invited to transfer to PCBC. Most have chosen to transfer to PCBC but others selected another" NB based outside of the UK.  

UL UK adds to the uncertainty facing industry around preparations for post-Brexit changes in addition to the increased requirements that will come into effect under the EU’s medical device and IVD regulations (MDR/IVDR) on 26 May 2020 and 26 May 2022, respectively. Both Brexit and MDR/IVDR created turmoil over a lack of guidance to timely support preparations across the sector, despite the changing regulatory system regardless of a Brexit deal.
 
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance earlier this year on the post-Brexit regulations of medical devices and IVDs in the event of a no-deal scenario. MHRA clarified that UK NBs will lose their designation status, but noted the UK’s version of MDR and IVDR will follow the same 3- and 5-year transition periods as the EU. "UL will act in a supporting role to PCBC" under UK MDR/IVDR, said Eisenhart.
 
Other UK-based NBs, meanwhile, have made moves in anticipation of Brexit and EU MDR/IVDR. BSI UK became the first NB to be designated against MDR in January, followed by TÜV SÜD in May. BSI UK subsequently told clients to transfer CE certificates “as a matter of urgency” over the EU-UK political impasse. London-based Lloyd's Register Quality Assurance (LRQA) also notified last month of its decision not to apply for designation under EU MDR nor IVDR.
 
LRQA’s decision reduces the total number of UK NBs that will be available under MDR/IVDR to three. The SGS United Kingdom Limited said in February it is undergoing the process to become designated against MDR.

"UL UK has not applied for designation under MDR/IVDR," said Eisenhart. "For the time being, UL will support PCBC."

BSI UK recently reported, citing the European Commission, that nearly 50% of all medical device products in the EU use UK NBs.

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