With under two months left on the Brexit timeline, BSI is urging medical device manufacturers to migrate existing CE certificates from BSI UK to its Netherlands (NL) entity “as a matter of urgency.”
BSI Group—the national standards body of the UK—expressed dissatisfaction in a notice
to manufacturers toward the current political
situation between Britain and the EU as a hard Brexit becomes more widely accepted as the most likely scenario after the Article 50 deadline of 29 March.
The group said that it “could not have foreseen the lack of political progress” when its NL contingency plan was initiated in 2016. Citing the “current political impasse” and updates that both of the competent authorities for BSI recently requested, the group moved to obtain “critical information” from the Dutch Health and Youth Care Inspectorate/Ministry of Health, Welfare and Sport and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Its notice provided an update based on the discussions.
As noted in MHRA’s January guidance
on no-deal Brexit preparations set for UK-based pharmaceutical and medical device manufacturers, CE certificates issued by UK-based notified bodies (NBs) will no longer be valid as of 30 March 2019 without a deal.
“Very importantly,” BSI noted, manufacturers will not be able to transfer or migrate any existing CE certificate to an EU NB once invalidated post-Brexit. “Products will lose market access and a new conformity assessment will be required,” BSI added. MHRA’s recent guidance proposed a new registration process to redirect the medical devices placed on the European market over the past several decades that will lose UK-issued CE certificates in the event of leaving the EU with no deal.
MHRA’s proposal for a new registration process would extend current registration requirements to cover all medical devices, active implantable devices, in vitro
diagnostic devices and custom-made devices. Registration requirements would be phased-in based on class-specific grace periods. The guidance’s proposed arrangements for modifications to existing UK regulations also include granting UK-based NBs an ongoing legal status to ensure continued supply of medical devices in the UK market.
Yet BSI said it “very strongly recommend[s] manufacturers migrate their existing BSI UK NB CE certificates to BSI NL NB as a matter of urgency,” adding that failing to complete this migration process before 29 March “creates a likelihood of interrupted market access.” Failure could also “lead to prolonged interruption” and require full conformity assessments, BSI said. For all active CE certificates that are not currently undergoing any changes, BSI intends to migrate such certificates to its NL entity.
BSI also outlined a two-pronged approach for migrating CE certificates currently in the work in progress category. The first pathway—for projects in the pre-certification stage—is set for BSI to migrate the existing CE certificate to NL before the end of March. Projects that are in the certificate decision-making stage will be fully processed and issued certificates prior to migration within the required timelines.
“Currently our waiting time for migration is very short but this will increase as we near the Brexit deadline,” BSI cautioned. The group said it onboarded additional staff to meet the anticipated growth in workload and is “diverting significant resources from other activities” to “urgently” complete this work.
BSI UK became
the first NB to be designated against the EU’s medical device regulation (MDR) just last month and its ongoing audit against the EU’s in vitro
diagnostic regulation (IVDR) is on track for IVDR NB designation in upcoming months.
The UK government intends to establish its own version of MDR/IVDR by 30 March 2019 and have the regulations come into force under the same 2020/2022 transitions as the EU, though the draft legislation for these plans to take effect in the event of a hard Brexit was introduced
in Parliament just last month. BSI NL NB has yet to achieve its MDR or IVDR designation but intends to do so by year’s end.