MDD and AIMDD legacy certificates in Great Britain: deadlines, exclusions and validity

1. Key takeaways

For products holding EU MDD (93/42/EEC) or AIMDD (90/385/EEC) certificates, the usable period in Great Britain is the earlier of the certificate expiry date and 23:59 on 30 June 2028. Official guidance additionally makes clear that custom-made devices compliant with EU MDD or AIMDD can no longer be placed on the Great Britain market at all. The long-term recognition decision announced on 21 October 2026 does not cover this group of products: they remain governed by the fixed statutory dates, and every plan for them must be built against 2028 rather than against the indefinite recognition headline.

This makes the MDD and AIMDD legacy population the most time-pressured segment of any portfolio. Unlike MDR and IVDR certificate holders, who gained open-ended recognition, legacy certificate holders face a hard wall whose position depends partly on their own certificate dates and partly on a statute that Parliament has already fixed. The work required is therefore not monitoring but execution: checking each certificate, classifying each product against the eligibility filters, and moving the ones that fail into either an MDR upgrade or a UKCA route in good time.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 1ZA(1) (reg 19B and reg 30A expire at 23:59 on 30 June 2028), reg 19B(3), reg 19B(3A) and reg 30A(3).
• SI 2023/627 reg 4, reg 6 and reg 8: fixes the dates and adds certificate validity conditions (reg 19B(3)(ba) and reg 30A(3)(ba)).
• Official guidance: the GOV.UK document titled ‘Timelines for acceptance of CE marked medical devices in Great Britain (GB)’.

3. Expert insights

Insight one: reg 19B(3A) is the hidden reef for Class I products. SI 2023/627 reg 6(4) inserts reg 19B(3A), which provides that reg 19B(3) applies only to former-directives Class I devices satisfying one of two conditions: (a) the conformity assessment procedure under Article 11 of the directives required the involvement of a notified body; or (b) the device would require notified body involvement if assessed under EU MDR Article 52. Devices satisfying neither condition are excluded from the transition entirely. The same logic appears in reg 7(7)(e) as a restriction on system and procedure packs. The practical effect is that a self-declared Class I device with no notified body history is not automatically safe: its fate depends on what EU MDR would have demanded of it.

Insight two: certificate validity must be assessed by reference to the EU transition provisions. Under reg 19B(3)(ba) and reg 30A(3)(ba), certificates issued under Directive 90/385 or Directive 93/42 that remain valid by virtue of the transitional provisions of EU MDR Article 120(2) are treated as valid for the purposes of the British regime. This obliges companies to look beyond the face of the certificate: a certificate whose printed validity has run out may still support the British transition if Article 120(2) keeps it alive in EU law, and conversely a certificate that looks valid on paper may have fallen out of the EU transition and thereby lost its British effect. The two legal systems must be checked in sequence, not in isolation.

Insight three: the declaration date is frozen. Reg 6(3)(c) and reg 8(3)(b) change the wording from draws up to has drawn up before 26 May 2021: the declaration of conformity must have been drawn up before 26 May 2021. This time anchor directly excludes products for which declarations were drawn up later, however complete their technical files may be. It also means the declaration date, an item often treated as administrative trivia, becomes a substantive eligibility criterion whose value should be verified against the signed original rather than against a database entry.

4. Practical recommendations

GRZAN recommends a dedicated stocktake of all MDD and AIMDD legacy products, sorted into four disposition categories by four dimensions: certificates expiring before 2028 (prioritise an EU MDR upgrade or UKCA); Class I devices falling within the reg 19B(3A) exclusion (immediately confirm whether any alternative route exists); declarations dated later than 26 May 2021 (assess the compliance risk); and custom-made devices (the CE route is closed, so a move to the UK MDR pathway is required). Each category carries a different urgency, and conflating them into one uniform action plan wastes both time and money.

The stocktake should record, for every product, the certificate number, the issuing body, the declaration date as signed, the Article 120(2) status, and the notified body answer for both the directive and the regulation. Once that dataset exists, the excluded population can be counted precisely, which is the number that determines whether the company needs one negotiated MDR upgrade project or a full re-certification programme, and it is the number that should drive the budget discussion with management.

5. Verification checklist

• □ Each certificate’s expiry date has been checked and the earlier date against 2028 has been computed
• □ Class I products have been assessed for notified body involvement under reg 19B(3A)
• □ Certificate validity under EU MDR Article 120(2) has been verified
• □ Declarations of conformity are dated before 26 May 2021
• □ Custom-made devices have been confirmed closed to the CE route and moved to the UK MDR pathway

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.