Great Britain will keep accepting CE-marked devices

A note from the author

Done well, regulation is one of the strongest competitive advantages a MedTech or HealthTech company can build, in Europe, the United States, and every market after them.

Regulatory Matters exists to make that advantage practical. Every two weeks we bring you the regulatory changes that touch your file, explained for a founder who is not a regulatory specialist, with what to do about each one and by when.

We will also take on the questions that decide how fast a device reaches patients and revenue. Why regulatory strategy belongs in your business plan from the first draft. How a credible regulatory plan strengthens your case with investors. Why the European and US routes are best planned together, from the start.

Good regulatory work is a competitive advantage, and it starts on the day you write your business plan.

Bringing a device to market is a journey, from the first idea to approval and on through every year you sell. Our role at Venitara is to guide you along it. This newsletter sits beside our YouTube channel, youtube.com/@Venitara-HQ, where we go further with longer educational content on each stage of that journey.

Our next issue is out on 5 November. If you want regulatory support before then, start at venitara.com.

Daren Wilson, Chief Operating Officer, Venitara

New to this? Three terms used throughout

CE mark. The mark showing that a device meets the EU rules that apply to it, so it may be sold across the EU and the European Economic Area (EEA).

Notified Body. An independent organisation designated by an EU country to audit quality systems and review technical documentation for medium- and high-risk devices. It issues their CE certificates.

EUDAMED. The European database on medical devices, covering registration, device identifiers, certificates, and vigilance. It is being introduced module by module.

Source: Venitara glossary, venitara.com/resources/glossary.

At a glance

If you already sell in the EU, your EUDAMED records are due by 28 November

Sources: MHRA, 21 Oct 2026 · MHRA registration guidance on annual fees · Reg. (EU) 2024/1860, Art. 123(3)(e), with the notice of 27 Nov 2025 · Reg. (EU) 2026/1744. Checked 21 Oct 2026.

Great Britain keeps accepting CE marks

What the MHRA confirmed, and what it has not yet said

For a company that gets its CE mark in the EU first, Great Britain no longer means planning a second conformity route.

On 21 October 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that it will continue to accept CE-marked medical devices in Great Britain on a long-term basis. The decision follows a consultation that ran from 16 February to 10 April 2026 and drew more than 1,000 responses.

Two things are still missing: the legislation that gives it effect, and a commencement date. Until both are published, plan on the decision without assuming its legal form.

MHRA, 21 October 2026: The MHRA "has today, 21 October 2026, confirmed it will continue to accept CE marked medical devices on a long-term basis."

A week earlier, the MHRA Strategy 2030 set out where the regime goes next. It plans reliance routes with other regulators, including the US Food and Drug Administration (FDA), membership of the Medical Device Single Audit Program (MDSAP), unique device identifiers or an equivalent system, and new powers for regulatory assessments. The identifier requirement and the new assessment powers both need parliamentary approval.

Applies to you if you hold, or plan, a CE mark and sell or will sell in Great Britain. The next UK action is paying any unpaid registration fees by 6 November (see Dates ahead).

What it means for you

• MedTech founders. A CE mark remains your route into Great Britain. Budget for UK registration, and keep the second assessment out of the plan.
• Companies already selling in Great Britain. Nothing changes in your file this month. Check that your MHRA registration and fees are current.
• Regulatory professionals. Watch for the statutory instrument. Its scope and start date decide what the confirmation covers.

AI Act: a quality-system standard for AI device makers

AI device makers now have a harmonised quality-system standard

Commission Implementing Decision (EU) 2026/2274, adopted on 12 October and published in the Official Journal on 14 October, references EN 18286:2026, a quality management system standard for AI, as harmonised under the AI Act. The Commission's standardisation page links it to the Act's quality-system requirements in Article 17.

A harmonised standard gives a presumption of conformity only for the AI Act requirements it covers. It says nothing about conformity under the Medical Device Regulation (MDR). For AI in medical devices, the Act's obligations apply from 2 August 2028 under Regulation (EU) 2026/1744.

Term: harmonised standard. A European standard whose reference is published in the Official Journal, giving a presumption of conformity with the requirements it covers.

Source: Implementing Decision (EU) 2026/2274, Official Journal, 14 October 2026. Checked 21 October 2026.

Applies to you if you build AI-enabled medical software and are planning your quality system.

MDR revision: nothing changes for your file yet

The MDR and IVDR revision moves in Parliament

The Commission's proposal to simplify the MDR and the In Vitro Diagnostic Regulation (IVDR), COM(2025) 1023, moved in the European Parliament on 15 October, when the internal market committee (IMCO) appointed its rapporteur for an opinion.

Source: Legislative Observatory, procedure 2025/0404(COD). Checked 21 October 2026.

How to: register your devices in EUDAMED before 28 November

For companies already on the market.

Devices you were placing on the market before 28 May 2026, and still are, need their records in EUDAMED, the European database on medical devices, by 28 November 2026. That date is our calculation: twelve months from the Commission notice of 27 November 2025, under MDR Article 123(3)(e) as inserted by Regulation (EU) 2024/1860.

1. List the devices the deadline covers. Every device first placed before 28 May that you still place, legacy devices included. MDR Art. 123(3)(e)
2. Register the company and obtain its SRN. Actor registration comes before any device and gives you a single registration number (SRN). MDR Art. 31
3. Name at least two Confirmers. Only a Confirmer can submit a device, so one absence cannot stop a November submission. EUDAMED user guide v2.27.0
4. Build the data from the label and the technical file. EUDAMED checks the format of a Basic UDI-DI, the identifier that groups devices sharing an intended purpose, risk class, and essential design, never whether it is right. MDR Art. 27(7), 29(1)
5. Ask your Notified Body how long confirmation takes. Certificate-linked devices wait at "Submitted" until the Notified Body confirms. MDR Art. 29(3)
6. Check every record's status after submission. No source says whether "Submitted" on 28 November meets the obligation, so raise it with your Notified Body early. EUDAMED user guide v2.27.0
7. Keep dated evidence of what you entered. Submission date, status reached, and a copy of the data, filed beside your list of device identifiers. MDR Art. 27(7), 31(4)

Mistakes on the record: four FDA cases from October

Four FDA cases this month, and the control that catches each

No notice below cites a clause as the cause. Each control is general good practice, offered as a lesson for a company building its first quality system.

Nova Biomedical: a result assigned to the wrong patient. FDA, 6 and 20 October. Information from a previous scan could stay on the meter screen and be accepted for the next patient. The FDA reports one serious injury. The control: verify every path by which patient identity reaches a result.

Philips Lumify: scanning blocked without a signal. FDA Class I recall, the most serious type, 19 October. The app could ask for re-registration that needs Wi-Fi or cellular coverage before scanning could continue. The control: test connectivity failure in every setting the intended use covers.

Medline and AVID: whole kits destroyed for one component. FDA Class I recall, 13 and 14 October. Kits contained BD ChloraPrep applicators recalled by their own manufacturer, so every affected kit had to go. The control: trace each purchased component by lot into every finished kit.

Olympus: unclear roles between sites and the corporate centre. FDA warning letter, 7 October. Inspections at six facilities; the FDA questioned oversight of repeat issues across sites. The control: write down which quality responsibilities sit with each site.

Sources: FDA recall and warning letter databases, entries dated 6–20 October 2026. Checked 21 October 2026.

Eight dates to watch before the end of January

What falls due before the end of January

Checked 21 October 2026.

CH: Switzerland.

The question: does "Submitted" in EUDAMED mean our devices are compliant?

The EUDAMED user guide says "Submitted" means the record is waiting for the Notified Body to confirm and is not yet public. No source says whether that status meets the 28 November obligation. Chase your Notified Body in writing now, and keep a dated record of the submission.

How this issue was compiled. From Venitara's monitoring reports covering 8 to 21 October 2026. Every regulatory statement was checked against its primary source on 21 October 2026, and the regulatory statements were reviewed by Niko Mangold. Regulatory Matters is general information and does not replace an assessment of your device. The cover and section images were generated for Venitara with Higgsfield.