British inventions are marketed overseas as new Brexit safety certification rules mean they cannot be sold in the UK.
Trade bodies and contractors have blamed the government’s decision to stop accepting the European Union CE mark and instead create a new UK Conformity Assessed (UKCA) mark showing that a product is safe.
When the new system is in place, it means a manufacturer will have to pass one set of tests for the EU and another for the UK, creating additional layers of bureaucracy. But some things can’t be tested yet because the UK doesn’t have facilities to test building products, including glue, sealants and glass, or some medical supplies.
An entrepreneur in the UK told the Observer that he had been unable to get a medical device certified in the UK or the EU and so had set up a business in the US, where the product would be manufactured and sold. Medical industry sources said UK companies were also opening divisions in Japan.
The switch from CE to UKCA was due to take place last year but was delayed and will now come into effect on December 31, 2022 at midnight European time. But ministers have further delayed mandatory UKCA marking for electrical products like iPhones, so CE marking can still be used until 2025.
Then, last week, the Medicines and Healthcare Products Regulatory Agency announced that it was recommending a delay until July 2024 for medical products.
Yet some sectors will still face a cliff on New Year’s Day, and the Construction Leadership Council, representing the building industry, wrote to new Business Secretary Grant Shapps and new Housing Secretary Michael Gove last week, warning them that plans for new homes, schools and hospitals were affected. “About 28% of the products are imported and half [those] of the EU, and therefore these products are also affected,” the letter states. “As a result, many global manufacturers now view the UK as simply too difficult to do business in, which has led to product withdrawals, impacting the UK’s ability to deliver completed projects. .”
One of the letter’s authors, Peter Caplehorn, chief executive of the Construction Products Association, said: ‘It affects foreign investment [and] innovation. Products are under continuous development and, from the beginning of the year, if a product is significantly modified or upgraded, then it will need to be recertified.
“We have a test facility in the UK [for] radiators. And they did an analysis on the amount of heaters they put in their system. If they were to retest them all, it would take 75 years.
Steve Lee, director of diagnostics regulation for the Association of British Healthtech Industries (ABHI), said the MHRA’s delay would be helpful, but the uncertainty was already causing serious problems. “People don’t see the UK or the EU as a place to innovate and bring new products to market,” he said. “People are looking to other jurisdictions because the regulatory landscape is so uncertain.”
A major change in EU law means manufacturers face a similar problem in Europe. The changes – introduced after scandals linked to the rupture of breast implants and metal-on-metal hip implants – have also led to a delay in medical device testing in the EU. One in 10 medical device manufacturers in the UK have stopped trying to innovate, according to an ABHI survey of its members.
Around 600,000 medical products – from syringes and surgical instruments to HIV tests and hip replacements – are in use in the UK, but ABHI members reported in a survey this month that a out of five will be taken off the market over the next five years. Two-thirds expect the arrival of new devices in the UK to be delayed. “There will almost certainly be products that will be temporarily or permanently unavailable for use in the UK,” Lee said.
The British Chambers of Commerce (BCC) said there was more uncertainty stemming from the government’s decision to allow CE marked products in Northern Ireland, which has no trade barriers with the EU.
“By the end of 2025, CE marked products made in Northern Ireland will be able to circulate in Britain, but not those from the EU, Switzerland or Turkey,” said William Bain, head of trade policy at the BCC. “How will they tell the difference between products made in Northern Ireland and those that are imported into Northern Ireland and then sent to Britain? All of this needs to be resolved, and it creates great uncertainty. »
Manufacturers represented by Make UK want ministers to phase in the regulations, and three-quarters want CE marking to continue to be recognised. If UK regulations diverge significantly, two identical cars for UK and EU might have to be made with hundreds of different components.