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UK Responsible person

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Definition of UK responsible person as per UK MDR 2019 is “ a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under the regulations” to get the UKCA mark.

In order to place a device on the Great Britain market (England, Wales and Scotland) it is obligatory to register with MHRA. Manufacturers based outside the UK are required to appoint a person or a legal person (i.e. a company) established in the UK for carrying out this registration and to proceed for UKCA mark.

Manufacturer in UK or designated UK Responsible person can legally place a device in UK Market and proceed for UKCA mark. And a single manufacturer can also have several designated UK Responsible person.

The name and address of the UK Responsible Person, if applicable, will need to be included on product labeling along with the UKCA mark to ensure compliance to UKCA. The devices certified as per MDD/IVDD shall continue to be sold in UK and the Labeling does not have to change until June 2023. It is not necessary to include UKRP on labels of CE marked device.

A documentary evidence showing an agreement between manufacturer and UK responsible person. This UK responsible person agreement should be in the form of a headed letter or a signed contract which states the company name and address for both the overseas manufacturer and the UK Responsible Person.

Selection of UK Responsible person

There aren’t any specific requirements for qualifications or knowledge, as long as the UK Responsible Person is competent to carry out the responsibilities set out above.

A UK responsible person must have registered place of business as well as physical presence in the UK where technical documentation related to the products shall be maintained, local complaints shall be addressed, MHRA registrations shall be performed and this address shall also be used for official communications.

The grace period for manufacturers to have a UK Responsible Person available is the same as the grace period for the registration of devices with the MHRA:

Responsibilities of UK Responsible person

  • UK responsible person shall ensure that declaration of conformity and technical documentation where drawn up with an appropriate conformity assessment procedure has been carried out by the manufacturer to get the UKCA mark.
  • He/she shall also have a copy of the technical documentation and declaration of conformity and relevant certificate including amendments and supplements for inspection by the MHRA.
  •  UK responsible person shall provide a MHRA with all information and documentation necessary to demonstrate the conformity of the device.
  • UK responsible person shall also cooperate with MHRA on any CAPA taken to eliminate or to mitigate the risk posed by the device.
  • UK responsible person shall also immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated. 
  • UK responsible person shall also terminate with the manufacturer legally if he acts contrary to its obligations under these regulation and inform MHRA and relevant notified body about the termination.
  • UK responsible person shall also carry out specified tasks in relation to manufacturer’s obligation such as registration with MHRA before device placed in UK market.
  • UK Responsible Person will need to open a single registration account on behalf of the manufacturers that it represents.
  • UK Responsible Person shall also be responsible for post-market surveillance responsibilities.

FAQ:

UKCA mark will not be recognized in EU, EEA or Northern Ireland.

A signed contract between an overseas manufacturer and UKRP which contains all the legal terms and responsibilities included in the UK RP service.

The name and address of the UK Responsible Person, if applicable, will need to be included on product labeling along with the UKCA mark.

A UK responsible person must have registered place of business in the UK “at which service of any document relating in any way to the person’s placing of the relevant device on the market will be effective”.

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