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HighlightsHighlights Archive

Media Monitoring: 26th August – 1st September

Labour would resolve dangers of ‘outdated’ NHS equipment – Wes Streeting Thousands of patients across England have been injured by faulty medical equipment in A&E departments in the past five years, Labour has said. They intend the tackle the problem through bulk buying of equipment and cutting unnecessary red tape. Labour has estimated that almost 7,000 incidents could have been…
Dawn
September 1, 2023
HighlightsHighlights Archive

Three new UK Approved Bodies to certify medical devices announced by the MHRA

TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK. TÜV SÜD and Intertek have been designated as UK Approved Bodies to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. TÜV Rheinland UK has…
Dawn
September 1, 2023
HighlightsHighlights Archive

NICE testing guidance update will likely ensure 100,000 fewer colonoscopies annually

According to NICE, people with signs or symptoms of colorectal cancer should be offered a home test with quantitative faecal immunochemical tests (FIT) from 1 of 2 technologies (HM-JACKarc or OC-Sensor). This could lead to faster diagnosis, with fewer people referred to secondary care for an unnecessary colonoscopy. People who require follow up investigation can then be prioritised for referral…
Dawn
September 1, 2023
Membership NewsMembership News Archive

Cabinet Office publishes the final Border Target Operating Model (BTOM)

After acknowledging the view of industry and working with the Scottish and Welsh Devolved Administrations, the Government has delayed the introduction of remaining Sanitary and Phytosanitary (SPS) controls, as well as full customs controls for non-qualifying Northern Ireland goods, until January 2024 to support stakeholders in preparing for further checks. The revised timeline for the introduction of controls is as…
Dawn
September 1, 2023
HighlightsHighlights Archive

Media Monitoring: 29 July – 4 August

Funding boost for research hubs that drive Government health policy 20 new policy research units will receive between £2m and £5m over a three- to five-year contract. NIHR has backed the 20 new policy research units (PRUs), which will start work in January 2024. PRUs are typically based at universities and bring together teams of researchers who help the Government…
Dawn
August 4, 2023
HighlightsHighlights ArchiveUK Government Updates Regulatory Affairs Newsletter Archive

CE marking recognition for medical devices and in vitro diagnostics

The extended recognition of CE marking announced this week does not apply to medical devices or IVDs. The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to…
Dawn
August 4, 2023