Published on November 19, 2020

Starting in January 2021, trading of certain goods such as medical devices and in vitro diagnostic (IVD) devices in the UK market will require UK Conformity Assessment certification or the UKCA mark. To allow manufacturers time to adjust to the new requirements, CE marking will be accepted in the UK until the January 1, 2022 for some products.

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During the three years following the 2016 EU referendum, multiple aspects of the Brexit deal have been the subject of negotiations, including trade agreements between the UK and the EU. While the negotiations are still ongoing and the details of a possible “hard Brexit” are yet to be determined, on September 1, 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a Guidance on September 1, 2020. This describes the timeline of implementation of the upcoming laws that will regulate UKCA mark for medical devices and IVD starting in 2021. To place their products on the UK market, medical device and IVD manufacturers must register their products and ensure they possess the UKCA mark as proof of conformity. 

The UKCA Guidance

While the MHRA’s Guidance is pending legislation as of October 2020, this document outlines the mechanics of conformance to the essential requirements for UKCA marking, describes the process of conformity assessment, and indicates the standards to be used for demonstration of conformity. Based on the content of the Guidance, the MHRA is to designate regulatory bodies which, after an official appointment by the UK government, will handle conformity assessment and device registration in the UK. The EU Notified Bodies that were located in the UK and designated under the Medical Devices Directive (MDD) will automatically be designated to handle UKCA marking.

As part of the conformity assessment process to obtain and maintain UKCA mark, manufacturers will be required to conduct surveillance activities on their marketed products and the MHRA will be responsible for market surveillance. In addition, manufacturers must designate a UK Responsible Person or UK REP, who must be located in the UK, to handle the registration process and place the medical device or IVD on the UK market. It is not entirely clear what the function of the UK REP will be, however it appears as if the UK REP may act as the importer.

Medical device and IVD manufacturers are encouraged to initiate device registration as soon as possible, however the UKCA mark requirements will go into effect on January 1, 2021 with a grace period for device registration of 4, 8, and 12 months based on the specific risk level of the product. The higher the risk classification, the sooner UKCA registration is expected. During such transition time, CE mark will be accepted as long as the UK and the EU do not amend their legislations and until the law comes into full effect following the grace period on January 1, 2022. During the transition year, while device registration is mandatory, update of the device’s labelling is not required. Labelling updates will be required after June 30, 2023. Until then, a product must carry either the CE mark or the UKCA mark, but presence of the UKCA mark on labels is not per se a requirement.

Applicability of the UKCA regulatory scheme will not depend on any Free Trade Agreements (FTA) between the UK and the EU. While during the (up to) one-year grace period manufacturers can place medical devices and IVD products on the UK market with solely a CE-mark and no UKCA registration, the opposite may not be done and manufacturers may not place an UKCA-marked product in the EU market. Although the UK Conformity Assessment process will likely be similar to the EU Conformity Assessment for the most part, this means that manufacturers will nonetheless be required to demonstrate conformity and register their products separately in the UK and EU markets moving forward.

What Medical Device Manufacturers Should Expect

With many details regarding the UKCA regulatory route still to be clarified, medical device and IVD manufacturers should stay tuned for relevant updates. The UKCA Guidance released in September 2020 announced the upcoming publication of the UK medical device regulation (MDR), which will update the 2002 UK MDR. Meanwhile, although the UKCA Guidance as such, is not legally binding or proscriptive, manufacturers should nonetheless work ahead to be prepared for the upcoming UKCA requirements. Here are seven crucial steps to prepare for UKCA:

  • Stay abreast of the regulatory news. With a target implementation date announced for January 1, 2020, a UK MDR should likely be published by the end of 2020. Stay on top of the news by periodically reviewing the MHRA website as well as the RAPS website.
  • Review your product portfolio. With a new regulation expected to roll in the near term, weighing the cost of compliance against financial metrics relevant to your business objectives will help determine the best way forward with respect to the UK market. Pulling those metrics sooner rather than later will help with strategy and planning as soon as the upcoming regulation is published, thus increasing your chances to position your business ahead of competition.
  • Create a UKCA Program or Task Force within your organization. Because preparing for regulatory compliance impacts multiple areas of a business, setting up a program to handle UKCA strategy and execution should gain you the efficiency needed for a smooth transition. These programs should also include a UK Vigilance Program to handle device surveillance and reporting with the MHRA.
  • Identify a UK Responsible Person. Although the specifics of the role of a UK Responsible Person are yet to be clarified, identifying possible candidates and initiating conversations will likely save you some time later on. However, depending on whether the UK REP will also act as the importer, different requirements may come into play.
  • Establish relationships with UK Regulatory Bodies. According to the MHRA UKCA Guidance, the MHRA is to designate UK Regulatory Bodies and the UK government should subsequently appoint them. However, it seems that EU Notified Bodies located in the UK that were designated under MDD should likely be automatically designated under the upcoming UK regulation. So, this may be the time to revamp those relationships or establish them anew.
  • Plan UKCA submission timelines. Because the timeline for device registration with the MHRA is staggered based on device risk classification with 4, 8, and 12 months of grace period, creating a timeline for the UK Conformity Assessment execution and device registration can play in your favor and avoid any unnecessary delays or inefficiencies.
  • Start planning UK Conformity Assessment processes and procedures. Although the specifics of the UK Conformity Assessment process are yet to be published, it is likely that this process will be similar to the clinical evaluation exercise that is required to CE mark devices in the EU. Ideally, a UKCA Task Force specifically designated within your organization will work on the early stages of an institutional procedure for the Conformity Assessment process.

The uncertainties around the specifics of the UKCA regulatory route and upcoming UK regulation have warranted many to advocate for a “wait and watch” approach. However, many steps can be taken to prepare for the upcoming regulation and UKCA requirements in order to minimize areas of possible inefficiency and better position your business to remain competitive on the UK market and, ultimately, continue to deliver treatments to your patients.

Castor helps medical and IVD devices maintain compliance and receive regulatory approval (like the UKCA mark) faster. Contact us to learn more.

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