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Dear Colleagues
The Medicines and Healthcare products Regulatory Agency (MHRA) has today published new guidance on GOV.UK which sets out how medical devices will be regulated after the transition period with the EU has ended (from 1 January 2021).
Please note three key aspects in particular:
1. The EU Medical Devices Regulation (MDR) and in vitro Diagnostics Medical Devices Regulation (IVDR) will not be implemented in Great Britain. As you may be aware, these Regulations will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively and will not take effect until after the transition period has ended. They will not therefore be retained EU law as described by the EU Withdrawal Agreement Act.
Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices will continue to apply in Great Britain from 1 January 2021.
Our departure from the EU gives us the regulatory freedom to develop a new world-class regime for medical devices, with patient safety and access to devices at the forefront of our plans.
We will introduce a new domestic regulatory model for devices and will engage with stakeholders within the life sciences and healthcare sectors this autumn. As part of these discussions, we will identify and prioritise elements of international practice that promote public health and patient safety. This will be followed by a formal public consultation, which will take place before changes to underlying regulations take effect.
2. We will introduce a new UK route to market and mark of conformity for devices. The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market from 1 January 2021. Our guidance provides further information on how to UKCA mark your devices.
3. We will continue to recognise the CE marking until 30 June 2023. Although the UKCA mark will be available for manufacturers to use from 1 January 2021, we will continue to accept CE marked devices until 30 June 2023. This will allow time for the UK route to market to embed and for industry to adapt to these new requirements, ensuring a continued supply of safe devices to UK patients after the transition period.
Please be aware that vigilance guidance on reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices. Please note that the UK is no longer included in the listing of Competent Authorities on the European Commission’s Medical Devices web pages and incidents occurring in the UK and correction actions that affect the UK should be reported to the MHRA directly.
Subscribing to updates on GOV.UK
You can sign up for email updates about the MHRA’s work – you will then receive an email every time the MHRA publishes a new page or makes a significant edit to an existing page.
For more information, please visit mhra.gov.uk.
If you have specific questions relating to the contents of this guidance, please contact devices.regulatory@mhra.gov.uk.
Kind regards,
Patient, Public and Stakeholder Engagement team
Communications division
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 0203 080 6000
gov.uk/mhra
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