Updated 25 October 2026
Who holds medical device registrations in the United Kingdom
A manufacturer based outside the UK must appoint a UK Responsible Person to register its devices with the MHRA and act on its behalf before the devices are placed on the Great Britain market. The Index lists 1,628 UK Responsible Persons in the United Kingdom from the MHRA UK register, last read on 23 October 2026. The list also carries 23 authorised representatives for Northern Ireland.
Medical device companies in the United Kingdom: distributors, importers and makers
General information, not legal advice. Local law varies; take local counsel.
Who may hold a registration in the United Kingdom
A manufacturer based outside the UK must appoint a UK Responsible Person to register its devices with the MHRA and act on its behalf before the devices are placed on the Great Britain market. Importers and distributors do not need to appoint one. For Northern Ireland, a Great Britain-based manufacturer appoints an authorised representative based in the EU or Northern Ireland.
UK Responsible Persons in the United Kingdom: top 50
Ranked by manufacturer registrations it is named on. Each name opens its profile with roles, principals and sources.
- 1Emergo Consulting (UK) LimitedCambridge557 registrationsRegulatory representative
- 2478 registrationsRegulatory representative
- 3Qserve Group UK, Ltd.Hampshire305 registrationsRegulatory representative
- 4Advena LtdWarwick285 registrationsRegulatory representative
- 5MDSS-UK RP LIMITEDManchester229 registrationsRegulatory representative
- 6Obelis UK LtdOxford188 registrationsRegulatory representative
- 7Randox Laboratories LimitedCrumlin, County Antrim, Northern Ireland166 registrationsMaker's own entity
- 8KARL STORZ Endoscopy (UK) Ltd.Dundee, Angus162 registrationsMaker's own entity
- 9Rapid Labs LtdColchester, Essex149 registrationsMaker's own entity
- 10CMC Medical Devices LTDLondon137 registrationsMaker's own entity
- 11Wellkang LtdDerry, Northern Ireland134 registrationsRegulatory representative
- 12Medimap LtdThurston, Suffolk133 registrationsRegulatory representative
- 13OXOID LIMITEDBasingstoke,, Hampshire127 registrationsMaker's own entity
- 14Surgical Holdings Limited Trading as Surgical HoldingsSouthend-On-Sea, Essex120 registrationsMaker's own entity
- 15MedEnvoy UK LimitedLondon114 registrationsRegulatory representative
- 16QbD RepS UK Ltd.London110 registrationsRegulatory representative
- 17MedPath LimitedLondon99 registrationsRegulatory representative
- 1893 registrationsRegulatory representative
- 19UKCA Experts LtdNottingham93 registrationsRegulatory representative
- 20Precision Surgical LtdSheffield91 registrationsMaker's own entity
- 21IMMUNODIAGNOSTIC SYSTEMS LIMITEDBoldon Colliery Durham, TW85 registrationsMaker's own entity
- 2280 registrationsRegulatory representative
- 2378 registrationsRegulatory representative
- 24Ortho-Clinical DiagnosticsPencoed Bridgend68 registrationsMaker's own entity
- 25Wellkang LtdDover, Kent68 registrationsRegulatory representative
- 26MEDAGENT INTERNATIONAL UK LIMITEDLewes, East Sussex67 registrationsRegulatory representative
- 27Rocialle Healthcare LimitedMountain Ash, Rhondda63 registrationsMaker's own entity
- 28lotus global co ltdReading, Reading63 registrationsRegulatory representative
- 29AF PHARMA SERVICE UK LTDLondon56 registrationsRegulatory representative
- 30SHARE INFO LTDWalsall, West Midlands54 registrationsRegulatory representative
- 31JRI Orthopaedics LtdSheffield48 registrationsMaker's own entity
- 32BTL INDUSTRIES LIMITEDStevenage, HT48 registrationsMaker's own entity
- 33Commic International LtdAccrington, Lancashire47 registrationsMaker's own entity
- 34CASUS UKRP LTDLondon47 registrationsRegulatory representative
- 35QCS International LTD.Cumbernauld, North Lanarkshire46 registrationsRegulatory representative
- 36NPZ technology LtdCambridge, Cambridgeshire46 registrationsRegulatory representative
- 37Medes Ltd.Radlett, Herts46 registrationsRegulatory representative
- 38GBUK GROUP LIMITEDSelby North Yorkshire, N. Yorks45 registrationsMaker's own entity
- 39Easy Medical Device LimitedAltrincham44 registrationsMaker's own entity
- 40Etheria Medical LtdNewcastle Upon Tyne44 registrationsRegulatory representative
- 41BIO-DIAGNOSTICS LTD.Worcestershire, Worcestershire40 registrationsMaker's own entity
- 42CELLPATH LTDNewtown, Powys39 registrationsDistributor
- 43ALTOMED LTD.Boldon Colliery South Tyneside, Tyne And Wear39 registrationsMaker's own entity
- 44Microlink Technology Ltd T/A Pro-Lab DiagnosticsBromborough, Wirral36 registrationsMaker's own entity
- 45Medtronic LimitedWatford, Herts35 registrationsMaker's own entity
- 46INTERSURGICAL LTD.Wokingham, Berkshire, BK35 registrationsMaker's own entity
- 47Donawa Lifescience LtdChristchurch35 registrationsRegulatory representative
- 4835 registrationsRegulatory representative
- 49GE Medical Systems LimitedChalfont St Giles34 registrationsMaker's own entity
- 50European Device Solutions LtdWideopen, North Tyneside34 registrationsRegulatory representative
Download all 1,649 company rows as CSV
Company level only: names that are only a person's name are left out.
How many holders also distribute
6 of the 1,651 holders listed here (under 1%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.
The others: 951 makers' own import or sales entities and 694 regulatory representatives that hold registrations with no sign in the registries that they supply the market.
Holders that also distribute in the United Kingdom: top 6
- 1CELLPATH LTDNewtown, Powys39 registrationsDistributor
- 2Daybreak Medical LtdFeltham11 registrationsDistributor
- 3Eurosurgical LtdGuildford, Surrey10 registrationsDistributor
- 4Bakers Instrument Brokers Ltd. T/A BIB Ophthalmic InstrumentsStevenage, Hertfordshire9 registrationsDistributor
- 5Leib Medical LtdBelfast, Antrim, Northern Ireland2 registrationsDistributor
- 6OMC NI MEDICAL LIMITEDBelfast, Northern Ireland1 registrationDistributor
See every independent distributor in the United Kingdom on the country page.
Independent holders in the United Kingdom: top 20
Companies that hold registrations here with no sign in the registries that they supply the market themselves: regulatory representatives and holders as a service. A holder that is not your distributor keeps your distributors replaceable. Confirm what each one does before you appoint it.
- 1Emergo Consulting (UK) LimitedCambridge557 registrationsRegulatory representative
- 2478 registrationsRegulatory representative
- 3Qserve Group UK, Ltd.Hampshire305 registrationsRegulatory representative
- 4Advena LtdWarwick285 registrationsRegulatory representative
- 5MDSS-UK RP LIMITEDManchester229 registrationsRegulatory representative
- 6Obelis UK LtdOxford188 registrationsRegulatory representative
- 7Wellkang LtdDerry, Northern Ireland134 registrationsRegulatory representative
- 8Medimap LtdThurston, Suffolk133 registrationsRegulatory representative
- 9MedEnvoy UK LimitedLondon114 registrationsRegulatory representative
- 10QbD RepS UK Ltd.London110 registrationsRegulatory representative
- 11MedPath LimitedLondon99 registrationsRegulatory representative
- 1293 registrationsRegulatory representative
- 13UKCA Experts LtdNottingham93 registrationsRegulatory representative
- 1480 registrationsRegulatory representative
- 1578 registrationsRegulatory representative
- 16Wellkang LtdDover, Kent68 registrationsRegulatory representative
- 17MEDAGENT INTERNATIONAL UK LIMITEDLewes, East Sussex67 registrationsRegulatory representative
- 18lotus global co ltdReading, Reading63 registrationsRegulatory representative
- 19AF PHARMA SERVICE UK LTDLondon56 registrationsRegulatory representative
- 20SHARE INFO LTDWalsall, West Midlands54 registrationsRegulatory representative
Medical device registration in the United Kingdom with CE or FDA clearance
With CE marking: CE marking is accepted as it is.
With FDA clearance: A reliance route for FDA clearance has been announced but is not in force yet.
CE accepted in Great Britain until 30 June 2030 for MDR devices (30 June 2028 for MDD); indefinite recognition consulted in 2026. UK Responsible Person and MHRA registration required. FDA reliance route announced, not yet in force.
Sources: GOV.UK, Regulating medical devices in the UK (last updated 20 Feb 2026), GOV.UK press release, MHRA proposals including international reliance on FDA, Health Canada and TGA approvals. Confidence in this route: high, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.
How to check it yourself in the official register
MHRA Public Access Registration Database (PARD). Search the manufacturer. Its record names the UK Responsible Person, or for Northern Ireland the authorised representative, that acts for it.
The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.
What changes if you switch holder
The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.
Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable. In the Index, 694 of the companies listed here show no sign in the registries that they supply the market themselves, which is a place to start looking; confirm what each one does before you appoint it.
The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.
Next step
Registration holders in the United Kingdom: questions
Who can be a registration holder in the United Kingdom?
A manufacturer based outside the UK must appoint a UK Responsible Person to register its devices with the MHRA and act on its behalf before the devices are placed on the Great Britain market. Importers and distributors do not need to appoint one. For Northern Ireland, a Great Britain-based manufacturer appoints an authorised representative based in the EU or Northern Ireland.
Can a distributor hold my registration in the United Kingdom?
In the Index, 6 of the 1,651 UK Responsible Persons listed for the United Kingdom are also independent distributors. Whether your distributor should hold it is a separate decision, because the holder controls market access: see Who holds the registration.
Is there a list of UK Responsible Persons?
Yes. This page lists the top 50 of the 1,628 UK Responsible Persons the Index holds for the United Kingdom, each linked to its profile, and the CSV carries 1,649 company rows. The official record is the MHRA Public Access Registration Database (PARD).
How do I check who holds a device registration in the United Kingdom?
Use the MHRA Public Access Registration Database (PARD). Search the manufacturer. Its record names the UK Responsible Person, or for Northern Ireland the authorised representative, that acts for it.
Sources
- UK MHRA Public Access Registration Database (PARD): 1,651 establishments, last seen 23 October 2026. Public register.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 89 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 30 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- EUDAMED economic operator registration, European Commission public API: 13 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Company website (the establishment's own public site): 17 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.