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Detailed guide: Register as a manufacturer to sell medical devices

Medicines Healthcare Products Regulatory Agency

June 19
13:15 2020

Overview

If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.

Before you register, you must first complete a conformity assessment, so you can put the CE marking on your products.

We will only register manufacturers or authorised representatives that have a place of business in the UK. Distributors and suppliers cannot currently register with us.

If you are registering a Coronavirus (COVID-19) test kit with MHRA please take note of our guidance for industry and manufacturers. There are currently no CE marked tests for home use and it is currently illegal to supply such products in the UK.

We may request further technical documentation from you that demonstrate your products conform to the requirements of the Medical Device Regulations.

When you must register

Registering your device according to the EU Directives

For devices in compliance with the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD) and the in vitro Diagnostic Medical Devices Directive(IVDD).

It is a requirement of the UK Medical Device Regulations that you inform MHRA, the UK competent authority, when you first place certain devices on the market. You must register if you or your company sells, leases, lends or gifts:

  • class I devices you have manufactured
  • class I devices you have refurbished or re-labelled with your own name
  • any system or procedure pack containing at least one medical device
  • custom-made devices
  • IVDs you have manufactured
  • IVDs undergoing performance evaluation

We do not register devices classified as class IIa, IIb, III or active implantable devices which are not custom-made. For these, you need to follow the appropriate conformity assessment route, which includes assessment by a notified body.

Manufacturers without a place of business in the EU need to appoint an authorised representative in the EU. Only one authorised representative can be designated within the EU for each device type.

Registering your device according to the new EU Regulations

The EU Medical Devices Regulation (MDR) and in vitro Diagnostic Medical Devices Regulation (IVDR) entered into force on 25 May 2017, when the three- and five-year transition periods began. The MDR and IVDR will fully apply in EU Member States from 26 May 2021 and 2022 respectively.

During the transition period, devices can be put on the market under the current EU Directives, or the new Regulations (if you fully comply with the new Regulations).

During the transition period, the registration process remains unchanged for devices that comply with the Directives (the MDD, AIMDD and IVDD). However, if you wish to register devices under the new EU Regulations, you will need to tick the relevant box on the registration form to indicate that your devices fully comply with the new Regulations and not the Directives.

The MHRA will now accept registrations of the following devices, if they fully comply with the new Regulations:

  • Class I medical devices
  • Class A in vitro diagnostic medical devices

Find out more about the new MDR and IVDR.

Authorised representatives

If you are a designated authorised representative (AR) of a non-EU manufacturer we require documentary evidence supporting your position 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 AR. This document must state that the AR is acting with the consent of the overseas manufacturer and the legislation that applies for the devices being placed on the UK market.

If you are taking over the role from an existing authorised representative we need a new headed designation letter/contract and a copy of the letter cancelling the service of with the previous authorise representative.

The European Commission has guidance for authorised representatives.

Eligible devices and coding system

Class I devices

Examples of class I devices include:

  • dental and surgical instruments
  • stethoscopes and ophthalmoscopes
  • bandages and splints
  • spectacle lenses and frames
  • treatment chairs and hospital beds
  • stand-alone software

The European Commission has a guidance document Definitions of medical devices, accessory and manufacturer.

Custom-made devices

There is further information about custom-made devices and examples of the information we need.

If you are submitting a registration for a custom made active implantable device, you are required to provide us with a copy of the instructions for use and the device labelling.

System and procedure packs

You will need to register if your company:

  • places devices bearing the CE marking on the market, under your own name in a system or a procedure pack within their intended purposes and within the limits of uses specified by their original manufacturers
  • sterilises, for the purpose of placing on the market under your own name, systems or procedure packs or other CE marked medical devices designed by the manufacturer to be sterilised before use

To register your medical devices with MHRA, you must use Global Medical Devices Nomenclature (GMDN) to describe your devices. You do not need to be a member of the GMDN Agency to select GMDN terms within our online registration system.

In vitro diagnostic medical devices

Examples of IVD medical devices include cultures, reagents, antigens, serums, plasmas and testing kits and equipment for these.

To register your IVD devices with MHRA, you must use Global Medical Devices Nomenclature (GMDN) to describe your devices.

CE marking

There is further information about CE marking and the legal requirements for placing medical devices on the market.

Once you are satisfied that your devices meet all the relevant requirements, you can register with MHRA.

Apply to register with the Device Online Registration System (DORS)

Using DORS you can register medical devices and IVD devices and manage your account details. You need to create an account with MHRA and wait for an email confirming that its active before you c

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