BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR).
The new NB designation—the first-of-its-kind to be listed
in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database—comes months before the timeline the Notified Bodies Operations Group had estimated
in 2017 guidance for NB designation and notification.
The scope of BSI UK’s new MDR designation ranges from medical devices incorporating medicinal substances or nanomaterial to class III custom-made implantable devices, according to NANDO. BSI’s designation under the EU’s in vitro
diagnostic regulations (IVDR) is reportedly set for upcoming months.
The designation could ease certain concerns around a contentious issue
facing industry regarding the lack
of NB readiness and availability over the audits needed for compliance with MDR and IVDR prior to the 2020 and 2022 transitional deadlines, respectively. It underscores, however, a challenge with both the transitions for Brexit and the EU’s overhaul of device regulations occurring around the same time.
Brexit adds pressure on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to expedite NB designations in preparation for MDR, with a “no-deal” scenario looking increasingly more likely as the 29 March deadline for the exit approaches.
One challenge relates to the ongoing uncertainty that could hinder required preparations
for device manufacturers to comply with a changing regulatory landscape in the UK as well as in the EU, particularly under a no-deal. This has been exacerbated by the existing lack
of preparations for MDR/IVDR compliance, let alone for compliance in the UK post Brexit as various details are still being hashed out.
further guidance earlier this month to propose certain arrangements that would modify regulations as a result of a no-deal exit. The plan involves having a UK version of MDR/IVDR in place by 29 March 2019, but it also proposed to cease recognizing new CE markings issued by UK-based NBs.
“If there’s no deal, UK-based NBs will no longer be recognized by the EU after 29 March 2019,” MHRA said. This means that “these products will not be able to be placed on the EU market.” Such proposed arrangements in MHRA’s guidance spoke to the continued lack of clarity around what manufacturers, health care providers and patients, among others, can expect to happen to the EU market post Brexit.
“EU Commission data indicates that approaching half of all medical device products certified in the EU use UK notified bodies,” BSI said
Still, BSI UK achieved designation ahead of its anticipated timeline. BSI also intends to achieve designation for MDR/IVDR filings via the Netherlands before year’s end so that clients can have a fallback.