Self-declared Class I devices in Great Britain: eligibility and timelines

1. Key takeaways

Self-declared Class I devices do not automatically qualify for the British CE transition. Official guidance is explicit: such products may continue to be placed on the Great Britain market only in two situations. The first is where the device is self-declared under the EU MDR requirements, in which case the runway runs to 30 June 2030. The second is where the device was self-declared under EU MDD before 26 May 2021, where EU MDD required no notified body involvement but EU MDR does require it, which covers upclassified devices and reusable surgical instruments; for these the runway runs to 30 June 2028. Every other self-declared Class I configuration falls outside the transition and stops being placeable once the relevant basis ends.

The reason lies in the design of reg 19B(3A), inserted by SI 2023/627 reg 6(4). The provision filters former-directives Class I devices by whether a notified body would be needed under the new regulation, reflecting the policy judgement that devices which gained scrutiny when they moved into the MDR deserve a longer bridge than devices that would have remained unexamined. Reading the rule from the policy backwards makes the two runways easier to remember and easier to defend in internal reviews.

The screening burden should not be underestimated at portfolio scale. A Class I range of even modest size typically mixes all three tiers across the same catalogue: sterile or measuring variants sitting on directive certificates, pure self-declarations resting on MDR, and older MDD declarations whose date decides everything. Because the products look identical from the outside, the three tiers are invisible until each declaration is pulled and read, which is why the classification exercise must be treated as a document-level review rather than a category-level assumption.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 19B(3) and reg 19B(3A) (inserted by SI 2023/627 reg 6(4)).
• SI 2023/627 reg 6(3)(c) and reg 6(4): anchors the declaration date before 26 May 2021 and inserts the notified body involvement test in reg 19B(3A).
• Official guidance: the GOV.UK document titled ‘Timelines for acceptance of CE marked medical devices in Great Britain (GB)’.

3. Expert insights

Insight one: self-declaration splits into three fates. Products that are equally certificate-free, all sitting outside any notified body system, receive three different treatments in Great Britain depending on: the law the declaration rests on (MDR or MDD), the date of the declaration (before 26 May 2021 or not), and whether the device would be upclassified or fall into reusable surgical instruments under EU MDR. The three tiers correspond respectively to runway until 2030, runway until 2028, and no continued placing. Portfolio reviews that lump all Class I products together will systematically misstate the exposure, so the tiering must be done product by product.

Insight two: sterile and measuring Class I devices have a separate channel. The official guidance states that Class I devices with a sterile or measuring function that hold a valid EU MDD certificate may be placed on the market until 30 June 2028. This differs from the route available to ordinary self-declared Class I devices and must be tracked as its own line in the product ledger. Because these devices historically needed notified body involvement for the sterile or measuring aspect, the policy treats them closer to the higher-class devices than to pure self-declaration products, and that difference determines which date applies.

Insight three: a mirror rule exists on the IVD side. SI 2023/627 reg 9(4) inserts (3A) into reg 44ZA: for relevant devices that require no notified body involvement under Article 9 of the directives, the transition applies only where notified body involvement is required under EU IVDR Article 48. In practice this means products in the legacy ‘Others’ category under IVDD continue only in the specific conditions where the IVDR pulls them into notified body scope. The parallel structure with reg 19B(3A) is deliberate, and reviewing both provisions together is the fastest way to confirm a full IVD portfolio has been screened consistently.

4. Practical recommendations

GRZAN recommends adding three fields to the Class I product list: the law the declaration rests on, the date the declaration was signed, and whether a notified body would be required under EU MDR. The combination of the three fields reads off the British usable date directly, with no further interpretation required, which makes the review repeatable by staff who are not regulatory specialists. For products that fall into the no-continued-placing tier, priority should be given to assessing the UKCA self-assessment route: for Class I devices no UK approved body involvement is needed, so the path is comparatively short and can often be completed well before the CE basis ends.

Where the declaration date is close to the 26 May 2021 boundary, obtain the signed declaration rather than relying on a scanned copy or database record, since eligibility turns on that date. Where the MDR notified body answer is uncertain, document the reasoning against the classification rules, because the same determination will be reused for the IVD mirror test and for any future UKCA classification exercise, so a clearly reasoned record now saves three reviews later.

Timing matters as much as eligibility. Where a product qualifies for the 2028 runway but the certificate set is thin, the UKCA self-assessment work can be scheduled in the gap between the MDR notified body demand and the British cut-off, so that the same technical file work serves both the EU upgrade and the British continuation. Sequencing the two efforts against one another, rather than running them as unrelated projects, is what keeps small Class I portfolios affordable while the regulatory calendar advances on both fronts.

5. Verification checklist

• □ The law each self-declaration rests on has been confirmed (MDD / MDR)
• □ Whether each declaration was signed before 26 May 2021 has been confirmed
• □ Whether a notified body would be required under EU MDR has been determined
• □ Sterile and measuring function sub-categories have been handled separately
• □ IVD products have completed the mirror assessment under reg 44ZA(3A)

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.