UK Regulations for International Medical Device Manufacturers

Background

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:

• May 1st, 2021: Class IIIs and Class IIb implantable's, all active implantable medical devices and Annex II List A IVDs
• September 1st, 2021: Class IIb non-implantable, all Class IIa devices, IVD List B, and Self-test IVDs
• January 1st, 2022: Class I devices and General IVDs
• Until the new UK regulation (UKCA) will be mandatory (June 2023), devices/IVDs that are in compliance with the following directives/regulations can be placed on the UK market: MDD, MDR, IVD and IVDR.
• The UK RP address does not have to appear on the labelling, only when you apply for the UKCA mark.
• Labelling does not have to change until June 2023. When the manufacturer starts with compliance to the UKCA mark, the label must change to be in compliance.

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.

Requirements

• Only a manufacturer based in the UK or a designated UK Responsible Person can legally place a device on the UK market.
• A contract between manufacturer and UK responsible person must be signed supporting this position.
• This evidence should be in the form of a 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. There will be an increase in both the workload and certification requirements for the manufacturing company as there will be changes to both QMS, and labelling requirements in the manufacturers current systems as the manufacturer will still retain legal control of their Technical, Product and QMS files

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:

• May 1st, 2021: Class IIIs and Class IIb implantable, all active implantable medical devices and Annex II List A IVDs
• September 1st, 2021: Class IIb non-implantable, all Class IIa devices, IVD List B, and Self-test IVDs
• January 1st, 2022: Class I devices and General IVDs.
• Until the new UK regulation (UKCA) will be mandatory (June 2023), devices/IVDs that are in compliance with the following directives/regulations can be placed on the UK market: MDD, MDR, IVD and IVDR.
• The UK RP address does not have to appear on the labelling, only when you apply for the UKCA mark.
• Labelling does not have to change until June 2023. When the manufacturer starts with compliance to the UKCA mark, the label must change to be in compliance.

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:

• 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.

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:

• diagnosis, prevention, monitoring, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• investigation, replacement or modification of the anatomy or of a physiological process
• control of conception

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:

• The product compliance must be ensured
• The product must be classified
• A Notified Body must be involved (for products other than class I) and the technical file including the Declaration of Conformity must be prepared
• The CE mark must be affixed and labelling has been completed
• The Authorised Representative must be included in the manufacturer's product liability insurance
• An agreement between manufacturer and UK RepMed Limited has to be signed