Highly specialized jobs in Britain assessing whether products ranging from MRI scanners to phones can carry the “CE” safety label could be at risk post-Brexit after the European commission put manufacturers on notice over future standards.
In an official notice, the EC said the agencies that provide the safety certificates may not have their work acknowledged after 29 March 2019, unless an agreement can be reached.
More than 200 agencies, including the British Standards Institute and Lloyds Register, could be affected.
The EC said British-based “notified bodies will lose their status as EU notified bodies” and will be removed from the EU databases of such organizations from the withdrawal date.
Lloyds Register said it would be seeking to recruit staff in the Netherlands to Brexit-proof its operations. It offers manufacturers compliance tests under 14 of 15 safety directives including marine equipment and medical devices.
“We are taking action to mitigate risks and deal with the range of possible outcomes related to Brexit negotiations,” the organization said.
The BSI, which certifies high-end medical equipment like MRIs, heart valves and artificial hips, said the EC notice “outlines the worst-case where no withdrawal agreement is achieved”, and it hoped the condition would be averted.
“We expect this won’t happen and fully anticipate that a mutual recognition agreement will be achieved,” the BSI said.
Many of its clients use the UK as a gateway to Europe. Howard Kerr, the BSI chief executive, said that if a two-tier system emerged needing dual-certification for the EU and the UK, patients would be the loser.
He said manufacturers from other countries would priorities the large EU market for new products if they had to go through separate compliance procedures in both the UK and the EU.
“There is a danger that the UK patient [in that scenario] would not have as fast access to inventive products they are bringing on to market,” said Kerr.
The BSI certifies 7,000 products a year and uses highly specific teams of specialists like oncologists and bioengineers from around the world to assess new products. Another team of professionals based in the UK then makes the decision as to whether they should be awarded a CE certificate.
“It is a substantial industry. It is not just about jobs, it’s also about influence,” said Kerr, who has urged the government to press home the Europe-wide interest in retaining aligned standards after Brexit.
“There is still 14 months to go, we are not at D-day yet, but in the absence of any certainty there will come a time mid-year when manufacturers will have to choose [on alternative plans],” said Kerr.
The EC has advised manufacturers they should examine the “legal repercussions” and either get their future CE certification through an EU member state or transfer existing files to an EU-notified body, which could take between two and six months.
Martin Cotton, a member of Lloyds Register’s Brexit team, said the company already had substantial operations across Europe, and Rotterdam would be the “obvious choice” for its CE work in the event of no deal on certification.
The CE safety label is mandatory under 15 directives and covers a range of products including toys, medical devices, in vitro diagnostic tools, and marine equipment and noise emission devices.
Manufacturers can obtain their CE label from any member state but Britain has built up expertise in testing and EU data shows that two-thirds of medical devices on sale in the EU are CE certified in the UK.
The EC notice highlights the challenges facing exporters as a result of Britain’s decision to leave the EU and the risk to jobs in EU-related work. Last week the EU said it was moving a planned back-up monitoring service for the EU’s new Galileo satellite navigation system from the UK to Spain.
In November it declared it was relocating two key agencies, the European Medicines Agency and the European Banking Agency, to Amsterdam and Paris respectively.