Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on January 1, 2021, and the CE marked devices have a grace period until July 31, 2023, to eventually transition to the UKCA mark.
This 2- year grace period for UKCA marking is applicable to the CE marked devices that are already being exported to the UK. The medical devices launched for the first time in the UK, after the Brexit i.e., December 31, 2020, and the subsequent grace period for varied devices classes, must be UKCA marked.
As a medical device or IVD device manufacturer exporting to the UK market, are you aware of the next steps post the MHRA transition periods? Do you have an in-depth understanding of the below aspects?
- UK Medical Device Regulations- Introduction
- What is UKCA Marking?
- Routes for Compliance to UKCA Marking
- Timelines for UKCA Marking
- The UK Approved Bodies
- Impact for Manufacturers – UK & Non-UK
- Next Steps for Manufacturers
To navigate you through the ground-level dynamics and realities of UKCA marking and device registration in the UK, Freyr brings an exclusive on-demand webinar on “Medical Devices in the UK & UKCA Certification Readiness,” scheduled on May 25, 2022. In this webinar, our in-house Regulatory experts – Nisha Vempalle, Director, Medical Devices, and Igor Dorosh, Associate Director, Business Development, Europe & Africa, will discuss the details of the UKCA marking and the next steps for the manufacturers. Register now!