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Detailed guide: Regulating medical devices from 1 January 2021

Medicines Healthcare Products Regulatory Agency

September 1
14:01 2020

Overview

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the?EU?system.

This guidance provides information on how the UK system will operate, including for:

  • Getting your device certified
  • Conformity marking your device
  • Registering your device with the?MHRA

This guidance is divided into sections on the different rules in Great Britain (England, Wales and Scotland), Northern Ireland and the EU.

For Northern Ireland, different rules will apply to those in Great Britain after the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland

This guidance does not cover other New Legislative Framework products which are subject to separate guidance.

The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

Summary of key requirements for placing a device on the Great Britain market

From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:

  • CE marking will continue to be used and recognised until 30 June 2023
  • Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
  • A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
  • From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
    • 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
    • 8 months for other Class IIb and all Class IIa devices
    • 12 months for Class I devices
  • If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further detail on the UK Responsible Person is set out below.

The legislation

Legislation that will apply to Great Britain

Currently, devices are regulated under:

These directives are given effect in UK law through the?Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002). These Regulations (in the form in which they exist on 1 January 2021) will continue to have effect in Great Britain after the transition period.

The EU Medical Devices Regulation (MDR) and EU in vitro Diagnostic Medical Devices Regulation (IVDR) from 1 January 2021

The MDR and IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. As these regulations will not take effect until after the transition period with the EU has ended, they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain.

The Independent Medicines and Medical Devices Safety Review, which delivered its report this July, has highlighted the importance of strengthened regulations that do more to protect patients. We are committed to improving the standards and scrutiny of medical devices that reach UK patients. This will be enabled through the powers currently being created through the Medicines and Medical Devices Bill.

We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that puts patient safety at the heart of the regulatory system. We will take into consideration international standards and global harmonisation in the development of our future system.

We will engage with stakeholders within the life sciences and healthcare sectors this autumn. As part of these discussions, we will identify elements that promote public health and patient safety, putting these at the heart of what we do. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system.

There is further information below on how devices that have already been registered with the MHRA under the MDR or the IVDR will be regulated.

The role of the MHRA

The?MHRA?will continue to perform market surveillance of medical devices on the UK market and will be able to take decisions over the marketing and supply of a device in the UK.

The MHRA will continue to be responsible for the designation and monitoring of UK Conformity Assessment Bodies.

Further guidance is available on how the MHRA enforces the legislation on medical devices.

Requirements for those manufacturing and supplying devices in the UK

Overview

From 1 January 2021,?the roles and responsibilities of those manufacturing and supplying medical devices and?IVDs?will change.

Manufacturers wishing to place a device on the UK market will first need to register with the?MHRA. See guidance on registrations for more information.

Where a manufacturer is not established in the UK, in most cases it will need to designate a UK Responsible Person to register and act on its behalf. See guidance on UK Responsible Persons below for more information.

Manufacturers will need to comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs. See below for guidance on UKCA mark and Conformity Assessment Bodies and guidance on CE marking and Notified Bodies for more information.

Registrations in Great Britain

From 1 January 2021, any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.

The MHRA will only register devices where the manufacturer has a registered place of business in the UK. If the manufacturer is based outside the UK, they will need to designate a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

Manufacturers based outside the EEA who have an Authorised Representative that is established in Northern Ireland will not need to designate a UK Responsible Person when placing a device on the Northern Ireland market. In such cases, the Northern Ireland-based Authorised Representative will be able to register devices with the MHRA on the manufacturers behalf.

Once you are satisfied that your device meets all the relevant legal requirements set out above, you will be able to register it with the MHRA. Please note that these new registration requirements will not apply until 1 January 2021.

Registering your device from 1 January 2021

Given that this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process.

For the following devices, you will have 4 months to register with the MHRA (until 30 April 2021):

  • Active implantable medical devices
  • Class III medical devices
  • Class IIb implantable medical devices
  • IVD List A

For the following devices, you will have 8 months to register with the MHRA (until 31 August 2

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