AR - Medical

Authorized Representative / Responsible Person (Medical Devices)

For medical devices and in vitro diagnostic medical devices (IVDs), now the UK has left the EU. Manufacturers must appoint a UK-based Responsible Person or an EU Authorized Representative as there is no longer any mutual recognition.

In order to place devices on the EU market, manufacturers with an Authorized Representative based in the UK will need to establish a new Authorized Representative in an EU country, an complete the necessary registrations of your products.

There are some grace periods for registration based on the device classification. We have developed 2 short videos explaining the new requirements for Great Britain and Northern Ireland.

VIDEO GUIDES

REGULATING MEDICAL DEVICES (UK)

You can read more information on the UK Gov web site here about what is actually required.

GOV.UK

However to summarise:-

A new role – the UK Responsible Person – has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person, who must be established in the UK, acts on behalf of a manufacturer established outside the UK to 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

You can read more about the UK Responsible Person’s obligations in regulation 77 (for medical devices) and regulation 146 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).

EU Authorized Representative and UK Responsible Person Responsibilities

The EU Authorized Representative and UK Responsible Person roles are generally similar and include:

Change your Authorized Representative.

Changing your Authorized Representative is a fairly straightforward process. Article 13 of the Medical Device Regulation 2017/745 gives full details of how this can be done.

First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).

To be compliant, the manufacturer should address the following aspects:

The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.

The date until which the manufacturer can show the outgoing AR on the information or promotional material.

The transfer of documents, including confidentiality aspects and property rights.

The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.