HTA annual report, CE marked devices and biobank networks

This first issue of Sample Matters leads on two regulator documents: the Human Tissue Authority's annual report for 2025/26, read against last year's edition, and the government's decision on CE marked medical devices in Great Britain. Two biobank initiatives reported in the trade press complete the fortnight.

HTA annual report: more assessments, every target met

The HTA annual report for 2025/26 records 226 planned regulatory assessments across just over 1,000 licences and says all its key performance indicators were met or exceeded, a first for the organisation. In 2024/25 it completed 223 assessments and missed three targets, including licence application decisions (80 per cent within 90 days against a 90 per cent target); for 2025/26 the target was set at 70 per cent and 78 per cent was achieved.

What it means for sample custodians: the inspection mix is shifting by sector. According to the 2025/26 report, almost all Research sector inspections used a single inspector, Evaluated Self-Assessments were trialled across half the Public Display sector, and two-person unannounced inspections continued in the post-mortem sector because of "ongoing high levels of risk, incidents and shortfalls". The second Data Collection Exercise went to 547 establishments with a 100 per cent return rate, and the HTA uses those returns to inform risk profiling and inspection planning.

Incident reporting reaches anatomy

Sir Jonathan Michael's independent inquiry published its final report in July 2025 with 75 recommendations, one of which fell to the HTA: extending its HTARI incident reporting system to the Anatomy sector, which went live on 1 December 2025, as the annual report sets out. The HTA also published universal guidance on the dignity and care of the deceased in October 2025.

What it means for sample custodians: anatomy establishments now fall within the HTA's reportable incident system, and the HTA says the inquiry's broader questions about the care of the deceased will remain a key consideration for its regulatory work in 2026/27. Separately, the Duty to Report now covers the whole UK, with Scottish regulations from 1 July 2025 following England, Wales and Northern Ireland from 1 April 2024; the report says referrals increased, and the 2024/25 report put the average at 3.5 cases a month.

What is coming: SoHO, Codes of Practice and fees

The report says the EU Substances of Human Origin Regulations come into force in Northern Ireland in August 2027, and that in 2026/27 the HTA will move on to guidance and system development for a new licensing and regulatory model. It has also begun a multi-year review of its Codes of Practice, which will involve renewing guidance for the sectors it regulates.

What it means for sample custodians: Northern Ireland establishments will want to watch for SoHO guidance during 2026/27, and teams whose procedures reference the current codes will want to track each revision. Licence fees provide around 95 per cent of HTA funding, licence fee income rose year on year, and 2026/27 fees were published at the beginning of April 2026.

CE marked devices to stay on the GB market

The government response to the MHRA consultation, published on 21 October 2026 after 1,056 responses, says it intends to recognise CE marked medical and in vitro diagnostic (IVD) devices certified under the EU MDR and EU IVDR in Great Britain indefinitely. Devices approved under the older EU Medical Devices Directive will be accepted until the end of the EU transition period, currently 31 December 2028, and legislation is planned before 30 June 2028, subject to parliamentary approval.

What it means for sample custodians: the consultation paper estimated that around 90 per cent of devices on the GB market are CE marked, and the legal definition of an IVD includes specimen receptacles. Manufacturers must still appoint a UK responsible person where based outside the UK, register with the MHRA and meet post-market surveillance obligations, and the MHRA remains responsible for monitoring the safety of all medical devices in the UK, regardless of route to market. The changes apply to Great Britain only.

A research human milk biobank in Western Australia

Biobanking.com reports that the University of Western Australia has launched the WA Human Milk Biobank, holding more than 1,000 samples with capacity for more than 100,000, and will release aliquots stored at −80°C to researchers by application. The trade press report notes that UWA's description of it as Australia's first is the university's own claim, and that the announcement does not set out a full collection and quality-control protocol.

What it means for sample custodians: the report notes that milk composition varies within a feed, across lactation and by collection method, so shared collections depend on documenting collection timing, stage of lactation, donor characteristics and processing history for every aliquot.

Brazil sets up a national biobank network

Biobanking.com reports that Brazil's Ministry of Health has established the Brazilian Biobank Network (RBBMS), open on a voluntary basis to 108 biobanks approved under the national research ethics system, with institutions keeping their administrative autonomy. Planned activities include training, guidance documents and support for multicentre research.

What it means for sample custodians: the report stresses that joining does not guarantee access to specimens or data, which remain subject to ethical, legal, institutional and consent conditions, and that the network's effectiveness will depend on implementation.

On our radar

• DHSC and the HTA have published a framework agreement for 2026 to 2029 covering roles, accountability, governance and financial responsibilities; we have read only the landing page so far.
• The Scientist covers cell culture contamination; its feed summary says monitoring programmes and repositories of tested cells help labs manage contamination that visual checks miss.