The conformity seat most legal departments still do not staff.

Sartori has worked the London in-house market for more than 10 years, for device manufacturers, diagnostics companies, digital-health businesses and the health units of larger groups. Over the trailing three years the desk closed 24 in-house searches at a 93 percent completion rate, on a typical timeline of 4 to 7 months. Nine of those 24 were device, diagnostics or digital-health regulatory seats. The other 15 were commercial, corporate or generalist in-house mandates that happened to sit in the same sector. The nine are the subject of this page. That London book sits inside a global research programme that has mapped nearly 1.5 million lawyer profiles and has run quarterly market surveys since 2019.

The opening fact is organizational, not doctrinal. On the career pages of device and digital-health employers reviewed for this piece — including a long-standing wound-care and orthopaedics manufacturer and a London remote-monitoring company — Quality Assurance and Regulatory Affairs is listed as a function of its own. Legal is listed beside it, or folded into Corporate Functions. None of those pages advertised a title called “device regulatory counsel.” The credentialing infrastructure that does exist is scientific. RAPS, which connects about 30,000 professionals worldwide, issues RAC-Devices and MDR- and IVDR-specific compliance certifications. TOPRA, headquartered in London, registers MTOPRA holders as Chartered or Registered Scientists on a minimum of 50 continuing-professional-development hours a year, and co-runs postgraduate awards with the University of Hertfordshire. Those are Quality credentials. They are not a law degree and they are not a substitute for one.

That is the uncovered seat. A company selling a device or a digital-health product into Europe now needs one lawyer who can hold the conformity route under the EU medical-devices and in-vitro-diagnostics regimes, the post-Brexit UK registration path, software-as-a-medical-device classification, and the data and AI rules that sit on top of the same product. Most legal departments do not have that person. They have a regulatory-affairs team that owns the file and a generalist counsel who signs it. The general counsel still carries the UK Responsible Person liability, the Article 10a interruption notice, and the classification call when a software tool crosses the MHRA line. Signing is not holding.

Therapeutics hiring and collaboration-licensing hiring are adjacent and already owned elsewhere. A cell-and-gene regulatory seat is a different product, a different regulator conversation and a different candidate pool. A life-sciences licensing counsel is hired to paper a deal, not to keep a notified-body certificate alive. This page stays on devices, diagnostics and health software. The whole-specialism life-sciences hiring read is the sibling that owns the broader supply question; it is not repeated here.

Team-NB's 2025 survey put IVDR at 3,076 cumulative applications and 2,104 certificates among its 41 members, and said certificate-issuance growth slowed in 2025 to two-thirds rather than the doubling seen in 2023 and 2024. Sixty-one percent of new IVDR certificates issued in 2025 took 13 to 18 months. The 41 members issued 17,260 certificates in total, a mean of 347 per body against a median of 68 — capacity is concentrated, not evenly spread. Team-NB estimated its members represented 81 percent of all MDR certificates issued industry-wide. MDCG 2022-14, published in August 2022, was the Commission's own acknowledgment of a notified-body capacity shortfall — the diagnosed problem the 2023 extension was built to answer. A signing bonus does not move a notified-body clock. A title does not create a certificate slot.

ABHI and CPI's 2025 survey is the UK industry voice on the same squeeze. More than half of respondents said UK regulatory capacity across conformity assessment, approved bodies and the MHRA had worsened. Two-thirds believed other countries were doing more to promote AI adoption in HealthTech, naming the United States most often and pointing to Germany's DiGA pathway and France's PECAN scheme as structural benchmarks the UK lacks. Those are buyer-side reasons a head of legal cannot treat Great Britain as a residual market the panel firm will tidy up later. The launch-delay, withdrawal and funding-confidence cuts from the same survey sit on the chart below.

In Sartori's 2026 first-half quarterly survey wave, 38 of 55 London in-house respondents in medtech named the Great Britain / EU dual route as the reason they would not return the conformity file to a single outside firm. That wave sits inside the same research programme; it is not a second interview count. Three of the nine device-regulatory mandates drew a counter-offer, in line with the 32 percent incidence on the London in-house line. Offers that did go out still signed on the same 13-working-day median as the rest of the book. The stall is before the offer, not after it. Seven of the nine ran past five months, which is still inside the 4-to-7-month band and tells you where inside that band this seat lives.

BSI describes itself as holding dual designation — an EU notified body and a UK approved body — for device conformity assessment. Even the certification infrastructure had to become dual-hatted after Brexit. The MHRA's Software and AI as a Medical Device Change Programme page was published on 16 September 2021 and last substantively updated on 14 June 2023, more than three years before this article, while the Agency continues to issue narrower classification lines elsewhere. A head of legal who staffs against a single stale roadmap will miss the live line. That is a coverage limit on the public side. Sartori's London mapping has one of its own: it records admission and employer. It does not record RAC-Devices, PRRC or UK Responsible Person designation, because no public register of those credentials sits on a lawyer file. We can see the legal population. We cannot see, from the map alone, who can actually hold this seat.