Great Britain and the EU run closely aligned regimes. We handle UKCA and CE routes to the GB market, MHRA registration and your UK Responsible Person, then reuse one clinical evaluation and PMCF programme to serve both the UK and EU MDR.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar to reach the UK and EU markets. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that reads UK and EU requirements as one aligned problem. We build a clinical evaluation and PMCF programme that supports a UKCA or CE file for Great Britain and an EU MDR file at the same time, with in-house CRAs in the United Kingdom rather than outsourced monitoring.
Great Britain currently recognises both routes. We pick the fastest compliant one for your device and class, and keep it aligned with your EU MDR regulatory strategy.
Place a CE-marked device on the Great Britain market under current MHRA recognition arrangements, with your EU MDR file as the basis.
Conformity assessment via a UK Approved Body where UKCA is the preferred or required route, mapped to your device class.
Northern Ireland follows EU MDR under the Windsor Framework, so your EU file covers it directly.
We register your devices with the MHRA and set up your UK Responsible Person, the mandatory local point of contact for manufacturers based outside the UK, so your placing on the market is clean from day one.
UK MDR principles stay closely aligned with EU MDR 2017/745. We design the clinical evaluation and PMCF plan so a single programme feeds both files.
Confirm UKCA or CE, device class and the fastest compliant path.
Appoint the UK Responsible Person and register with the MHRA.
Build one CER and PMCF programme for UK and EU MDR.
NHS sites and registries with in-house UK CRAs.
PMCF, vigilance and MHRA reporting kept current.
Great Britain continues to recognise the CE mark for medical devices under current MHRA transitional arrangements, while the UKCA mark remains a valid route. Eclevar keeps your strategy aligned with the latest MHRA timelines so you place devices on the GB market by the most efficient compliant route. Northern Ireland follows the EU MDR under the Windsor Framework.
A manufacturer based outside the UK must appoint a UK Responsible Person (UKRP) to register devices with the MHRA and act as the local point of contact. Eclevar helps you structure this and the MHRA registration that goes with it.
Yes. UK MDR principles remain closely aligned with EU MDR 2017/745, so a well-designed clinical evaluation and PMCF programme can support both a UKCA or CE file for Great Britain and an EU MDR file, avoiding duplicated studies.
NHS hospital data and national registries such as the National Joint Registry (NJR), with PMCF endpoints aligned to these sources and to your Clinical Evaluation Report.
Yes. Eclevar deploys in-house CRAs in the United Kingdom, so site initiation, NHS Research Ethics Committee submissions and monitoring are handled by our own team rather than outsourced.
Talk to our team about your device class, your UKCA or CE route and how to reuse one evidence base across the UK and the EU.
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