Guidance

Medical devices: EU regulations for MDR and IVDR

What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Overview

This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Update on delay to full implementation

The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.

We are taking steps to plan for after the end of the transition period. We will provide guidance on this in due course in light of Government decisions required on the future of UK regulation. All decisions on regulations will be taken with a view to prioritising patient safety and ensuring patient access for medical devices.

In the meantime, the existing regulatory requirements should continue to be met.

Medical device types and their associated regulation

The 2 main medical devices and their associated regulations are:

You must meet the requirements in the relevant Regulation before your device can be placed on the market.

Introductory guide to MDR IVDR

We have created an interactive guide to the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) (PDF, 7.03MB, 27 pages)

Guidance for Annex XVI manufacturers

By May 2021, some products that do not have an intended medical purpose will be required to comply with the new regulations for medical devices. These groups of products are listed under Annex XVI of the Medical Device Regulations (MDR). Further information about the specific requirements of the MDR on these groups can be found in this leaflet: Guidance leaflet for products without an intended medical purpose (PDF, 160KB, 6 pages)

Placing a device on the market under the new Regulations

The Regulations ‘entered into force’ on 25 May, which is when the three- and five-year transition periods began. Therefore, 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 placed on the market under the current EU Directives, or the new Regulations (if they fully comply with the new Regulations).

However, devices placed on the market after the transition period will need to fully comply with the MDR, unless they wish to make use of the extended period of CE certificate validity.

CertificateValidity

This allows for CE certificates issued under the current Directives and within the transition period referred to above to remain valid for a maximum period of four years (MDR) and two years (IVDR) after the date it was issued.

However, a number of MDR/ IVDR provisions will ‘switch on’ at the date of full application and the original certifying notified body must also be designated under the new Regulations to qualify.

If you are manufacturing a medical device, you must meet new obligations set out in the Regulations. You will need to ensure:

  • the device has been correctly classified against the new risk classification criteria (Annex VIII of the MDR and IVDR)
  • general safety and performance requirements are met, including for labelling and technical documentation and quality management systems (Annex I of the MDR and IVDR)
  • increased requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
  • manufacturers have a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
  • economic operators in the supply chain are compliant
  • sufficient financial coverage is in place, in respect of a manufacturer’s potential liability (Article 10 of the MDR and IVDR)
  • the new vigilance reporting timescales are met and that an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR and IVDR)

There are number of other obligations that must be met, which can be found in Article 10 of the MDR and the IVDR.

You should also note that the IVDR will bring in some key changes that will impact on manufacturers of IVDs. Please be aware that:

  • changes to classification rules for IVDs will mean that 80-90% of IVDs will require a notified body to conduct a conformity assessment
  • manufacturers of IVDs will be required to produce significantly more performance evidence, which will need to be updated throughout the life cycle of the device
  • the performance and testing of Class D devices will need to be verified by reference laboratories
  • there will be a new consultation procedure for companion diagnostics

Health Institutions and the Regulations

We have produced a one-page guide to outline to key changes in the new MDR IVDR which affect health institutions.

Health Institutions and the MDR IVDR - One Pager (PDF, 53.9KB, 1 page)

We are developing guidance for health institutions wishing to apply the exemption to the new in vitro diagnostic medical device regulation (2017/746) and the new medical device regulation (2017/745). Our consultation on the guidance will run until 31 March 2019.

Devices regulations during the implementation period

The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements.

CE marking

For medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

Contact MHRA

Please direct any queries on the new Regulations to

devices.regulatory@mhra.gov.uk

Published 29 August 2017
Last updated 24 April 2020 + show all updates
  1. Published a new section following European Parliament and Council decision to delay the full implementation of the Medical Device Regulation by one year to 26 May 2021.

  2. Added new section on Guidance for Annex XVI manufacturers and added PDF attachment.

  3. Added a link to our consultation on the Health institution exemption for IVDR/MDR

  4. contact email address updated.

  5. Added a one-page guide to outline to key changes in the new MDR IVDR which affect health institutions.

  6. First published.