UKCA marking deadline
From 1st July 2024 new UK legislation will come into force.
Additional guidance can be found at GOV.UK dedicated webpage.
Given the stringent requirements on patient safety and device performance, accessing Great Britain market brings challenges that can delay your product launch. It is critical to work with a UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.
BSI UK (0086) is a leading Approved Body under the UK MDR 2002, as amended. We review your medical device to ensure conformity against UK legislation by offering a range of flexible product review services providing you with efficient pathways to bring your product to market.
Join us for part 2 of our Clinical Masterclass Series in 2023 and listen to our experts discuss various aspects of the MDR. From preparing a Clinical Evaluation Plan, to supporting you with preparing a Clinical Evaluation Report, advice on PMCF and SSCP and much more.