On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.
At the start of the year, the UK formally voted to leave the European Union (EU). In order to prepare for the UK’s departure from the EU, the British government published a general transition plan that outlines the implications of the Brexit for many industrial sectors, including that of the medical device and in vitro diagnostics (IVD) industries.
The latest update, “Using the UKCA mark from 1 January 2021,” calls for the requirement of a “UKCA” mark to be applied to medical devices and IVD products. Taking a closer look at the requirements which are connected to the application of this mark, it is clear that it resembles much of what was originally in place for CE mark applications. (It should be noted that different policies will apply to those in Northern Ireland and to Great Britain after the transition period.)
In summary, some of the key takeaways from September’s guidance include:
- From 1 January 2021, the guidance lays out technical requirements (‘essential requirements’) that a manufacturer must meet, as well as the conformity assessment processes and standards that can be used to demonstrate conformity. In reality, these requirements are seen as the same as they are today with not much change noted; the UKCA marking can be used from 1 January 2021.
- Products sold in Great Britain must apply the new CE marking (UKCA) by 1 January 2021. Manufacturers are encouraged to be ready to use the UKCA marking as soon as possible and preferably before this date.
- CE marking will continue to be used and recognized until 30 June 2023 for medical devices and IVD products. Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023.
- The CE marking will only be valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and a product is CE marked on the basis of the new rules, a manufacturer will not be able to use the CE marking to sell in Great Britain before 31 December 2021.
- The UKCA marking will not be recognized on the EU market. Products currently requiring a CE marking will still require a CE mark for sale in the EU from 1 January 2021 onward.
Manufacturers must use the new UKCA marking immediately after 1 January 2021 if all of the following apply.
A manufacturer’s product:
- is for the market in Great Britain
- is covered by legislation which requires the UKCA marking
- requires a mandatory third party conformity assessment
- a conformity assessment has been carried out by a UK conformity assessment body and the assessment hasn’t transferred the conformity assessment files from the UK body to an EU recognized body before 1 January 2021
The latter statement is particularly interesting since this makes clear that UK manufacturers can still reside on their CE mark after 1 January 2021, on the condition that they have managed to make a successful transfer to an EU-based NB prior to this date. If this is not the case, a manufacturer will must meet the new UK requirements that are connected to the UKCA mark. In the meantime, the UK will start appointing “UK Notified Bodies” or “approval bodies” after these have been designated by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Call for Mandatory Action with MHRA: MHRA will Continue to Dominate
In addition to the above changes, and in order to market a device in the UK, manufacturers must register their device with the MHRA. If a manufacturer is not currently registered with the MHRA, but plans to market a device within the UK, they need to register their device in accordance with the below timelines.
MHRA Registration Timelines
4 Months to Register
|8 Months to Register
(Prior to 31 August 2021)
|12 Months to Register
(Prior 31 December 2021
|· Active Implantable Medical Devices
· Class III Medical Devices
· Class IIb Implantable Devices
|· Class IIb Non-Implantable Medical Devices
· Class IIa Medical Devices
|· Class I Medical Devices
· General IVDs
|List B (Self – Test IVDs)
There is also a new requirement for a “UK Responsible Person” for those manufacturers based outside the UK. Identical in function to the EU Authorized Representative, the UK Responsible Person is required to ensure the UKCA mark can be applied. For those that are following the EU’s MDR and IVDR closely, the key responsibilities of the UKCA Responsible Person seem to align with the Person Responsible for Regulatory Compliance (PRRC).
There is also another caveat lurking underneath: as stated before, the CE marking on devices will only be valid in Great Britain for areas where GB and EU rules remain the same. If either GB or the EU changes regulations, this decision will render the CE mark as void.
In summary, although there is now more clarity on the rules surrounding the application of the UKCA mark, there are still many guidelines that must be followed, making roll-out somewhat of a challenge for UK manufacturers.
How can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for medical device and IVD manufacturers.
Learn more about our services here:
Current Senior Medical Writer at NAMSA, Richard has supported regulatory strategies, served as the authorized representative, developed tech files, ensured MDSAP and EN ISO 13485 compliance and consulted on both MDR and IVDR upgrades of technical files to meet the new regulatory requirements for both medical device and IVD manufacturers. Additionally he has also completed Post Market Surveillance work including the PMS Reports and supporting the PMCF studies, trained clients on auditing towards ISO 13485:2016 and MDR and supported vigilance reporting and product registrations. Richard has also served a Medical Device Lead Assessor at BSI prior to joining NAMSA. Richard holds a LLM degree in Medical Law from Northumbria University, a MSc degree in Structural Molecular Biology from the University of London (Birkbeck College) and a BSc degree in Biomedical Science from Coventry University.
Alex Laan has been in the IVD and Medical Device industry for a total of 20 years with 12 years spent working for a respectable EU Notified Body. Alex has held the position of Principal Certification Manager at DEKRA Certification BV, a Notified Body for IVDs and Medical Devices located in Arnhem, The Netherlands. Mr. Laan also worked for KEMA Quality, beginning in 2006, where he was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVDs and Medical Devices, including drug-device combinations. In these roles, Alex managed projects with large multinationals (e.g., Boston Scientific), as well as small start-up companies. Alex has been an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as direct contact for EU competent authorities and EMA on implementation of the EU IVDR (2017/746) and EU MDR (2017/745).