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British inventions are on the market abroad because Brexit’s new safety certification rules indicate they cannot be sold in the UK.
Industry groups and entrepreneurs have denounced the government’s decision to stop accepting the European Union’s CE mark and instead create a new UK Conformity Assessed (UKCA) mark to show that products are safe.
Once the new system is in place, manufacturers will have to pass a series of tests for the EU and the UK, which can be cumbersome. However, there are some that cannot be tested yet, as there are no facilities in the UK to test building products such as adhesives, sealants, glass and some medical supplies.
said the British entrepreneur. Observer Unable to obtain UK or EU certified medical devices, he set up a company in the US to manufacture and sell products. A British company is also setting up a division in Japan, according to medical industry sources.
The change from CE to UKCA, which was due to take place last year, has been postponed and will take effect at midnight on 31 December 2022 European time. However, the minister has further postponed his mandatory UKCA marking for electrical products such as the iPhone, so the CE marking can still be used until 2025.
Then, last week, the Medicines and Healthcare Products Regulatory Agency announced that it recommended a delay until July 2024 for medical products.
Still, some departments will face a cliffhanger on New Year’s Day. The Construction Leadership Council, which represents the construction industry, wrote last week a letter to new Commerce Secretary Grant Shapps and new Housing Secretary Michael Gove warning of plans for new homes and schools. And hospitals were affected. “About 28% of our products are imported, half of which are imported. [those] Therefore, these products will also be affected,” the letter said. “As a result, many global manufacturers now see the UK as too difficult to do business with, resulting in product withdrawals, impacting the UK’s ability to deliver completed projects. increase.”
One of the authors of the letter, Peter Caplehorn, CEO of the Building Products Association, said: [and] innovation. The product is in continuous development and recertification is required if the product has been significantly changed or upgraded since the turn of the year.
“We have one test facility in the UK. [for] radiator. They then analyzed how much radiator they put into the system. If we had to retest them all, it would take 75 years. ”
Steve Lee, director of diagnostics regulation at the UK Healthtech Industry Association (ABHI), said the MHRA delay would help, but the uncertainty was already causing serious problems. “People don’t see the UK or his EU as a place to innovate and bring new products to market,” he said. “The regulatory environment is so uncertain that people are looking to other jurisdictions.”
Significant changes in EU legislation mean manufacturers face similar problems in Europe. The change, introduced after scandals involving ruptured breast implants and metal-to-metal hip implants, has also caused a backlog of medical device testing in the EU. His one-tenth of UK medical device manufacturers have stopped trying to innovate, according to his ABHI survey of members.
About 600,000 medical products are in use in the UK, from syringes and surgical instruments to HIV tests and artificial hip joints, but ABHI members say one in five will leave the market in the next five years, according to a survey this month. reporting. Two-thirds expect new devices to arrive in the UK late. “There will almost certainly be products that are temporarily or permanently unavailable in the UK,” Lee said.
The British Chamber of Commerce (BCC) said further uncertainty arises 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 manufactured in Northern Ireland will be able to circulate in the UK, but not EU, Swiss or Turkish products,” said the BCC’s trade policy responsibilities. author William Bain said: “How do we differentiate between products made in Northern Ireland and those imported into Northern Ireland and sent to the UK? increase.”
Manufacturers represented by Make UK want the minister to phase in the regulation, with three-quarters wanting the CE mark to continue to be recognized. His two identical cars, one for the UK and one for the EU, could have to be built with hundreds of different components if UK regulations differ significantly.
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