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UK Regulations for International Medical Device Manufacturers


If you are a manufacturer of Medical Devices outside the UK you are required under the directives to appoint an Authorised Representative (UK Responsible Person). UK Rep Med Limited is able to act as your UK Responsible Person in the UK. The registration with the MHRA can only be submitted by UK manufacturers or a UK Responsible Person.

Impact for Manufacturers

There will be new regulations in the UK, “UKCA”, which will be mandatory by June 2023. Until that date, there is a grace period and the EU CE mark will be accepted.

Devices/IVDs that will be placed on the UK market will need to be registered with the MHRA.

Manufacturers will need to appoint a UK Responsible Person (UK RP) to perform the registration.

The UK RP needs to be appointed by manufacturers as soon as possible. The UK RP needs to have a UK entity and address.

Registration deadlines depend on the classification of the devices/IVDs:

UK MHRA Requirements

What is a UK Responsible Person?

The position of a UK Responsible Person - has been created under the UK MDR 2002 (as amended by the UK MDR 2019). As per the UK MDR responsible person 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.


What is the grace period for a UK Responsible Person?

The requirement for a manufacturer to have in place a UK Responsible Person is in line with the grace period for registering your devices with the MHRA. Details of the grace period for registrations is given in guidance on registrations. However, manufacturers may wish to appoint a UK Responsible Person before the end of the grace period for post-market surveillance purposes. Manufacturers will also need to take into consideration that they might need some time to establish a UK Responsible Person and draw up a mandate.

Registration deadlines depend on the classification of the devices/IVDs:

What are the key responsibilities of a UK Responsible Person

As per new registration requirement of the UK MDR 2002 (as amended by the UK MDR 2019).

The UK Responsible Person must:

What are the other responsibilities of a UK Responsible Person

Registration Responsibilities

The Responsible Person must carry out specified tasks in relation to the manufacturer's obligations. This includes registering with the MHRA before the device is placed on the UK market. The UK Responsible Person will need to open a single registration account on behalf of the manufacturers that it represents.

Post Market Surveillance Responsibilities

This UK Responsible Person will be required to meet certain reporting requirements, as set out in in the UK MDR 2002 (as amended by the UK MDR 2019)

Manufacturers will be required to determine whether there are any post-market surveillance responsibilities that the UK Responsible Person will be jointly responsible for. These responsibilities should be clearly set out in the mandate drawn up between the manufacturer and the UK Responsible Person. The manufacturer will still be required to meet all of its obligations, regardless of what the UK Responsible Person is responsible for.

Location of the UK Responsible Person

A UK responsible person must have registered place of business in the UK. This address will be used for official communications,

Qualifications and requirements

for UK Responsible Person Under current Directives, there are no specific requirements stated, this said all staff at UK RepMed Limited are qualified and they have many years of experience in regulatory requirements both with medical devices and notified bodies together with registration expertise.

EU Requirements

According to European Directives a European Authorised Representative has to be designated by a manufacturer of medical devices, in-vitro diagnostics and cosmetic products that is not located within the European Community. The specific tasks of the European Authorised Representative are described in the medical device directives MDD 93/42/EEC and AIMDD 90/385/EEC, the in-vitro diagnostic directive IVDD 98/79/EC and the cosmetic regulation 1223/2009.

What is a Medical Device?

According to the Medical Device Directive MDD 93/42/EEC a 'medical device' is defined as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

For UK RepMed Limited to act as your European Authorised Representative, the manufacturer must complete the following steps:

Our professional team is here to help you with any questions or concerns.

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