Q.01

When do medical device manufacturers need a UK Responsible Person?

A manufacturer needs a UK Responsible Person (UKRP) when it is based outside the United Kingdom and wants to place devices on the Great Britain market. Under the UK MDR 2002 it must appoint a single ("sole") UKRP before it places any device on the market. This applies to general medical devices (regulation 7A), active implantable devices (regulation 21A) and IVDs (regulation 33A).

Approach: I read the revised GB text of the UK Medical Devices Regulations 2002 (SI 2002/618) and MHRA's guidance on registering devices and on regulating devices in the UK, Great Britain and Northern Ireland.

The legal trigger

  • No one may place a relevant device on the GB market unless they are established in Great Britain and have registered first [1].
  • A manufacturer based outside the UK meets this by appointing a sole UKRP. That UKRP then gives the Secretary of State written evidence that the manufacturer has authorised it to act [1][2][3].
  • A manufacturer based in Great Britain does not need a UKRP. It simply gives MHRA the address of its registered place of business in GB [1].

What MHRA says the requirement covers

  • Registration is needed for anyone who sells, leases, lends or gifts:
    • Class I, IIa, IIb or III devices they have manufactured, or refurbished or re-labelled under their own name;
    • system or procedure packs;
    • custom-made devices;
    • IVDs, including IVDs in performance evaluation.
  • A manufacturer outside the UK "must appoint a single UK Responsible Person to take responsibility for all of their medical devices". The UKRP then takes on the manufacturer's duty to register with MHRA [4].
  • Non-UK manufacturers who place IVDs on the market for performance evaluation studies in GB need a UKRP in order to register. The registration has to be in place by the time the study starts [5].
  • MHRA has closed the device registration accounts of former GB-based Authorised Representatives who had not changed their role to UKRP by 30 March 2026 [4].

What the UKRP must do Regulation 7A(3) says the UKRP "must" [1]:

  • ensure the declaration of conformity and technical documentation have been drawn up, and that the manufacturer has carried out any applicable conformity assessment;
  • keep copies of the technical documentation, declaration of conformity and any certificate available for MHRA to inspect;
  • provide conformity information and documentation when asked;
  • provide samples or access to the device when asked, or pass the request on to the manufacturer;
  • cooperate on preventive and corrective actions;
  • immediately tell the manufacturer about complaints and suspected-incident reports;
  • if the manufacturer breaches its obligations, end the relationship and tell MHRA and, where relevant, the approved body.

The UKRP also has to tell MHRA about importers: GB importers must inform the manufacturer or UKRP that they intend to import a device, and the manufacturer or UKRP then sends the importer's details to MHRA [6].

Liability Under regulation 60(3), which covers England, Wales and Scotland, a UKRP "may be proceeded against" as the person placing the device on the market. It can also be proceeded against as a supplier for later supply within the UK [7].

Northern Ireland is different The UKRP regime applies to Great Britain. Northern Ireland has its own version of regulation 60, which requires a manufacturer with no registered place of business "in a relevant state" to designate a single authorised representative [7]. MHRA guidance says authorised representatives for the NI and EU markets can be based in Northern Ireland or the EU [8]. Regulation 21C, the NI provision headed "Requirement to appoint a UK responsible person for active implantable medical devices", was omitted on 21 March 2024 by SI 2024/221 [9].

Q.02

What must the UK Responsible Person do?

A UK Responsible Person (UKRP) must register the non-UK manufacturer's devices with MHRA. It must also carry out eight tasks set out in the UK MDR 2002. The same list appears in regulation 7A(3) for general devices, regulation 21A(3) for active implantables and regulation 33A(3) for IVDs. In each case the wording is "must" [1][2][3].

Approach: I read the revised Great Britain text of the UK Medical Devices Regulations 2002 (SI 2002/618) and MHRA's guidance on device registration and on regulating devices in Great Britain and Northern Ireland, including its reference guides for the registration system.

The eight statutory tasks (regulation 7A(3)(a)-(h); 21A(3) and 33A(3) use the same wording)

  1. (a) Make sure the declaration of conformity and technical documentation have been drawn up. Where applicable, make sure the manufacturer has carried out an appropriate conformity assessment procedure.
  2. (b) Keep a copy of the technical documentation, the declaration of conformity and, if applicable, the relevant certificate, including any amendments and supplements. Regulations 7A and 33A say these must be kept "available for inspection by" the Secretary of State. Regulation 21A says "available to" the Secretary of State [2].
  3. (c) When the Secretary of State asks, provide all the information and documentation needed to show that a device conforms.
  4. (d) If it has samples of or access to the device, comply with any request to provide them.
  5. (e) If it has neither, pass the request on to the manufacturer and tell the Secretary of State whether the manufacturer intends to comply.
  6. (f) Cooperate on any preventive or corrective action to eliminate the risks posed by devices or, if that is not possible, to reduce them.
  7. (g) Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents involving a device it represents.
  8. (h) If the manufacturer acts against its obligations under the Regulations, end the legal relationship with it. Then tell the Secretary of State and, if applicable, the relevant approved body that it has done so [1].

MHRA's guidance repeats this list, with "the MHRA" in place of "the Secretary of State" [10].

Registration and notification duties

  • Proof of authority. The UKRP must give the Secretary of State written evidence that it has the manufacturer's authority to act as its UKRP. It must then register the devices: provide a device description and pay the fee under regulation 53, before the device is placed on the market (regulation 7A(2)) [1].
  • Extra IVD information. For IVDs, the registration must also include the "relevant information" listed in regulation 33A(4). This covers, for example, a statement that a device is a "new relevant device", and identification data for Annex II-listed and self-test devices. Within two years of a new relevant device being placed on the market, the Secretary of State may ask for a report on experience with the device (33A(5)) [3].
  • Changes. The person responsible for the registration information must tell the Secretary of State about any changes to it (regulation 7A(2A)) [1].
  • Importers. A GB importer that is not itself the UKRP must tell the manufacturer or UKRP that it intends to import. The manufacturer or UKRP then sends the importer's details, including its GB place of business, to MHRA [6].
  • IVD performance evaluation. IVDs in performance evaluation studies must be registered by the time the study starts [5].

Labelling The UKRP's name and address must appear on the label, the outer packaging or the instructions for use where the device carries the UKCA mark. This includes devices marked with both UKCA and CE. A device with only the CE mark does not need the UKRP's details [10][11].

Letter of Designation (MHRA registration system, April 2026 reference guides)

  • The UKRP uploads a Letter of Designation for each manufacturer it represents. This "must be a legal contract" that names it as the sole UKRP and lists the mandatory tasks it is contracted to carry out [12].
  • The letter's validity dates should match the contract's start and end dates. The maximum validity is 5 years.
  • If the letter expires before a new one is uploaded, MHRA suspends the account until a valid letter is uploaded. While suspended, the UKRP is "no longer lawfully allowed to place devices on to the UK market", and its details are removed from MHRA's public registration database (PARD) [13].

Who can be a UKRP MHRA says nothing prevents an importer or distributor from also acting as UKRP. Importers and distributors do not themselves need to appoint one [10].

Q.03

How is the UK Responsible Person named in MHRA registration?

The UKRP is not entered as a field on the manufacturer's own record. In MHRA's device registration system (DORS), the UKRP's own organisation account (role "UK Responsible Person") adds the non-UK manufacturer as a represented organisation. It then confirms that it is representing that manufacturer as UKRP and uploads a Letter of Designation naming it as the sole UKRP. Once registered, MHRA's public register (PARD) shows the UKRP's name and address inside the manufacturer's record.

Approach: I used MHRA's "Register medical devices to place on the market" guidance and its April 2026 reference guides: Device Registration, Account Management, DORS Fees, and the Manufacturer/Device/Product/Importer attributes spreadsheet.

1. The UKRP's account carries the role

  • The account's "Organisation role" field is mandatory. Its options are Manufacturer, UK Responsible Person, or AR (NI only) [14].
  • When updating the role, you select "UK Responsible Person" and must select your country (England, Scotland, Wales, Northern Ireland) [15].
  • Former GB Authorised Representatives can switch their role to UKRP. Their link to each represented manufacturer then becomes "UK Responsible Person" [16][17].
  • A pure UKRP account correctly shows "Not Registered" unless the UKRP also registers devices as a manufacturer [18][19].

2. The UKRP adds the manufacturer

  • Only UKRPs of manufacturers outside the UK (or NI-based Authorised Representatives of manufacturers outside the EU) should use "Add New Manufacturer". It is used when the UKRP is ready to register devices for that manufacturer. MHRA says not to create several accounts for the same manufacturer [20].
  • The UKRP ticks "I wish to represent this manufacturer as UK Responsible Person" and enters the contact at the manufacturer. MHRA asks UKRPs not to enter their own contact details there [21].
  • That selection is mandatory and cannot be edited after registration. A change needs a new registration with a fee [22].
  • Represented manufacturers then appear in the UKRP's "Manufacturers you represent" table [18].

3. The Letter of Designation names the UKRP

  • Uploading it is mandatory for represented manufacturers. Accepted formats are doc, docx, pdf, jpg, tif, png and odt, up to 15 MB [23].
  • It "must be a legal contract" stating that you are the sole UKRP acting for the manufacturer, and it must list the mandatory tasks you are contracted to carry out. Its validity dates should match the contract dates, up to a maximum of 5 years [13].
  • The main guidance calls it a contract naming "the exclusive UK Responsible Person". It sits alongside the manufacturer's details: legal entity name and address as on the label, company type and administrative contact [24].

4. Keeping the naming current

  • UKRP name change: a new Letter of Designation must be uploaded for each represented manufacturer [25].
  • Change to a manufacturer's details: a new letter must be uploaded for that manufacturer, and changes take effect only after MHRA accepts them [25].
  • Ending representation: the UKRP "must" unregister the manufacturer. The manufacturer's status becomes "Unregistered" and it can no longer lawfully place devices on the UK market [25].
  • Expired letter or unpaid fee: the account is suspended. For a UKRP, all its represented manufacturers' accounts are suspended too and removed from PARD [26].

5. Importers When the UKRP adds an importer, it ticks whether it is associated with that importer as UKRP and/or manufacturer, then selects the represented manufacturers the importer imports for [27].

6. What the public sees (PARD) PARD lists the manufacturer's name, address, MHRA reference number, GMDN terms and codes, and brand names. The UKRP's (or NI Authorised Representative's) name and address are "displayed within the manufacturer record". MHRA notes PARD cannot currently be searched by representative [28]. Completed registrations usually appear the week after completion [29].

Q.04