UK Responsible Person
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), applicable in a no-deal Brexit.
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" as per UK MDR 2019.
Only a manufacturer or a designated UK Responsible Person can legally place a device on the UK market. This means that a single manufacturer may have several designated UK Responsible Persons.
A documentary evidence in the form of contract between manufacturer and UK responsible person must be signed supporting his position. This evidence should be in the form of a headed letter (letter of designation) or signed contract, which states the company name and address for both the overseas manufacturer and the UK Responsible Person.
This document must state that the UK Responsible Person is acting with the consent of the overseas manufacturer and adheres to the legislation that applies for the devices being placed on the UK market.
If a company establishes itself as a UK Responsible Person, the responsibilities of the UK Responsible Person would fall to the company as a whole. This is the same situation as for an EU Authorised Representative.
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 set out in our 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.
KEY RESPONSIBILITIES OF UK RESPONSIBLE PERSON
As per new registration requirement in Part II (r. 7A), Part III (r. 21A) and Part IV (r. 33A) and in new Parts VIII and IX in regulation 77 (for medical devices) and regulation 146 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).
The UK Responsible Person must:
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
- In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- 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.
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
OTHER RESPONSIBILITIES OF RESPONSIBLE PERSON
He 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 regulation 7A (for medical devices), regulation 21A (for active implantable medical devices) and regulation 33A (for IVDs) 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 “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”. This address will be used for official communications,
Qualifications and requirements for UK Responsible Person
There aren’t any specific requirements for qualifications or knowledge, so long as the UK Responsible Person is competent to carry out the responsibilities of a UK Responsible Person as set out above.
Regulation 60 of the UK MDR 2002 (as amended by the UK MDR 2019) sets out that a UK Responsible Person can be proceeded against as a person placing the device on the market for the purposes of the Regulations. As the UK MDR 2002 (as amended by the UK MDR 2019) are safety regulations for the purposes of the Consumer Protection Act, it is possible that a UK Responsible Person may be proceeded against under the Regulations or under the Consumer Protection Act 1987 if they fail to perform any of their obligations. It is also possible that an individual could be held liable.
Whilst not a requirement until Part VIII of the UK MDR 2019 fully applies in May 2020, the manufacturer may already have insurance in place. The UK Responsible Person may wish to include in its mandate whether it has the benefit of that insurance, or an indemnity based on the existence of that insurance, from the manufacturer.