The European Commission (EC) should act in the “best interest of citizens” and establish a transition period to allow manufacturers to keep placing medical devices certified by a UK Notified Body (NB) on the EU market under a no-deal Brexit, trade association COCIR urged Wednesday in an open letter.
The European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry—otherwise known as COCIR—expressed its concerns around the increasingly likely no-deal Brexit in its open letter to the EC and national competent authorities for medical devices.
COCIR noted that UK NBs will no longer be able to issue EU certificates, non-EU manufacturers will need to change all UK-based authorized representatives to ones based in the EU-27 and those that are transferring to a new EU-27-based NB will need device labeling changes for compliance with the Medical Device Directives. These are the “major concerns” facing industry if the UK and the EU fail to reach a Brexit agreement by 29 March.
To address the concerns, COCIR suggested that the EC and the EU-27 member states adopt a transition period to provide medical device manufacturers directly impacted by a no-deal Brexit more time to receive certification by a new NB and continue placing devices certified by a UK NB on the EU market.
COCIR argued that the standard practice in transitions to new NBs would be a six-month grace period from the day of withdrawal to allow manufacturers to implement needed changes to device labeling, without potential repercussions over noncompliance, citing guidance
developed by the Notified Body Operations Group.
“Even 12 to 18 months could be necessary in case manufacturers have to switch to a completely new Notified Body to ensure the necessary time for the re-certification process,” COCIR said.
The open letter underscores how medical device manufacturers need certainty for timely preparations around a no-deal scenario, particularly since Brexit transitions are not the only ones that are currently taking place. Manufacturers are also preparing to comply with the increased regulatory requirements that will come into full effect on 26 May 2020 under the EU medical device regulation (MDR) and on 26 May 2022 under the EU in vitro
diagnostic regulation (IVDR).
The UK’s Medicines and Health product Agency (MHRA) adopted
new transition periods for medical device compliance with new regulatory requirements in the event of a no-deal Brexit in addition to the same transitions the EU set for MDR and IVDR. But the EC has not and the first MDR guidance from the EU was issued
just this month.
At the center of the uncertainty facing industry regarding the EU market post-no-deal-Brexit lies the unaddressed issue of what will happen to new medical products cleared in the UK seeking EU access.
Adopting a transition period for medical devices on the EU market would preserve citizens’ best interest because the re-labelling of all devices directly impacted by a no-deal Brexit “would be challenging at best and unfeasible in many cases,” the trade association explained. Manufacturers with large product portfolios are expected to be impacted the most. “If devices are not available, even temporarily, the resulting impact on European healthcare systems—and the safety of EU citizens—could be substantial.”
COCIR, which recently commenced its chairmanship of DITTA, also called for a long-term solution in the form of a trade agreement between the EU and the UK that includes mutual recognition of medical device certification. MHRA has yet to specify what its version of the CE mark would be post-no-deal-Brexit. Recent guidance noted
that existing CE certificates issued by UK-based NBs will lose their validity in the EU as of 30 March, prompting urgency
for their migration to avoid losing market access.
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe