CE marking transition timelines in Great Britain: 2028 and 2030 expiry dates

1. Key takeaways

The current CE transition in the United Kingdom is built around two fixed expiry points. Devices and system or procedure packs relying on EU MDD (93/42/EEC) or AIMDD (90/385/EEC) certificates lose their transitional basis when the relevant provisions expire at 23:59 on 30 June 2028 (reg 19B and reg 30A). Devices relying on EU MDR (2017/745), EU IVDR (2017/746) or EU IVDD (98/79/EC) certificates run until 23:59 on 30 June 2030 (reg 19C, reg 44ZA and reg 44ZB). These dates are set by SI 2023/627, which replaced the original expiry mechanism in reg 1ZA of the UK MDR 2002.

The decisive point for planning is that the usable period is the earlier of the fixed date and the certificate expiry date. A product whose certificate runs out in 2027 stops being placeable in 2027, whatever the statute says about 2028 or 2030. Every runway calculation must therefore combine a statutory date with a commercial date, and the shorter of the two governs. Official guidance is explicit that an expired certificate cannot be relied upon, so there is no grace period once a certificate lapses, and no argument that the statutory window should bridge the gap until renewal is complete.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 1ZA(1), (2) and (3).
• SI 2023/627 reg 4: replaces reg 1ZA and provides expressly that reg 19B and reg 30A expire at 23:59 on 30 June 2028; that reg 19C, reg 44ZA and reg 44ZB expire at 23:59 on 30 June 2030; and that certain provisions already expired at 23:59 on 30 June 2023.
• Official guidance: the GOV.UK document titled ‘Timelines for acceptance of CE marked medical devices in Great Britain (GB)’.

3. Expert insights

Insight one: the earlier-of rule is the most commonly overlooked cost item. The two statutory dates are ceilings, not promises. If a CE certificate expires in 2027 and is not renewed, the British runway for that device terminates in 2027, regardless of the 2028 and 2030 dates. The official guidance states clearly that reliance on an expired certificate is not permitted. For portfolio planning this means the certificate register, not the statute book, is the binding constraint for most companies, and the certificate register is the part that commercial teams forget to check when they plan launches and stock builds for the British market.

Insight two: SI 2023/627 also tightened the conditions of certificate validity. Regulations 6 to 10 add requirements inside reg 19B, reg 19C, reg 30A, reg 44ZA and reg 44ZB: the manufacturer must ensure that the certificate relevant to the conformity assessment has not expired and has not been withdrawn (for example reg 19C(3)(ba) and reg 44ZB(3)(ba)), or that it remains valid under EU MDR Article 120(2) or EU IVDR Article 110(2) (reg 19B(3)(ba), reg 30A(3)(ba) and reg 44ZA(3)(ba)). This is a second gate, independent of the fixed dates. A device can sit comfortably inside the statutory window and still fall out of the transition the moment its certificate is withdrawn or lapses under EU law.

Insight three: the 30 June 2023 date, although past, still matters. Reg 1ZA(3) lists provisions that already expired on 30 June 2023, including reg 19B(4)(5)(8)(9), reg 19C(8)(9), reg 30A(4) to (7), reg 44ZA(4)(5) and reg 44ZB(4)(5). When reconstructing the historical compliance position of a product, for example in a due diligence exercise, an acquisition review or a response to an MHRA information request, these sub-provisions must be checked, because obligations that look alive in a current consolidated text may in fact have carried different content during earlier periods of the transition.

4. Practical recommendations

GRZAN recommends building a British runway ledger for every CE certificate. The fields should include: certificate number, issuing body, the EU law the certificate rests on, certificate expiry date, applicable transition provision, the statutory British expiry point, the effective cut-off date (the earlier of the two), and the status of the renewal plan. The ledger converts a stack of certificates into a single sortable dataset in which every product’s remaining runway can be read directly, sorted by urgency, and reviewed with the notified body pipeline in mind.

The ledger should be maintained jointly by the UKRP and the manufacturer, and updated immediately whenever a certificate status changes: renewal granted, renewal applied for, withdrawal notified, or suspension suspected. Updates should carry a date and a named owner so that the record remains audit-ready. Where the effective cut-off date falls within the next twenty-four months, the ledger should trigger a documented escalation, since renewal lead times at conformity assessment bodies are now long enough that a late start can leave no realistic path before the cut-off arrives.

5. Verification checklist

• □ The EU law each certificate rests on has been confirmed (MDD / AIMDD / IVDD / MDR / IVDR)
• □ Certificate expiry dates have been checked and the earlier of the two dates has been taken
• □ Certificates have been confirmed not expired and not withdrawn (reg 19C(3)(ba) and the like)
• □ No reliance is placed on provisions that already expired on 30 June 2023
• □ The British runway ledger has been built and an update owner has been named

Regulatory information verified as of 29 October 2026.

• Appointment of a UK responsible person (UKRP) and support for signing the letter of authorisation
• MHRA registration (DORS): end-to-end filing and account lifecycle management
• Device classification, GMDN code selection and annual registration fee estimates
• Dual-route design for Great Britain and Northern Ireland, including UK(NI) options
• Post-market surveillance (PMS) system build, PMSR/PSUR preparation and vigilance reporting
• Emergency handling of serious incidents and field safety corrective actions (FSCA)
• Monitoring of UK regulatory change and compliance gap assessments

GRZAN supports manufacturers entering the United Kingdom with UKCA registration pathways and classification strategy, from first route analysis through to registration and post-market obligations. For a structured review of your product portfolio, contact info@grzanglobal.com.