9 September 2020
BSI would like to share with you a critical announcement regarding the new UK Conformity Assessed (UKCA) mark for medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated after the transition period with the EU has ended (from 1 January 2021). We are currently working through the details and preparing questions for the MHRA to gain clarity in several areas; at this time, we would like to highlight the publication and urge you to familiarize yourself the details.
The MHRA has noted three key aspects in particular; for the full details, please refer to the GOV.UK website:
- The EU Medical Devices Regulation (MDR) and In Vitro Diagnostics 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. The 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.
- We will introduce a new UK route to market and mark of conformity for devices. The UKCA 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.
- 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.
BSI notes that existing UK notified bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process. This automatic rollover includes BSI’s UK Notified Body (0086), and we would like to confirm our intention to work as a UKCA Approved Body completing conformity assessments for the UK.
I will be running a webinar to provide you with an update and more details on this guidance on Tuesday 29 September 2020. I am pleased to be joined by Senior Vice President, Gary Slack, to discuss BSI’s strategic approach to the new regulation and how we will implement this alongside our EU Notified Body role. Please join the webinar to hear the latest information.
We will continue to monitor for further developments and will keep this page current. Please keep in mind that this is new information and we will be reviewing and updating our procedures to ensure we can react in the required timelines to support clients. Our priority is to maintain patient safety.
Please note for all your European market access needs, BSI’s Notified Body in the Netherlands (2797) continues to provide full scope medical device and in vitro diagnostic conformity assessments for all EU directives and regulations.
We thank you for your support with this additional regulatory transformation.
Dr Jayanth Katta.
Senior Regulatory Lead, BSI Notified Body.