Brexit compliance, application of the EU MDR, and upcoming IVDR deadline, Europe is the busiest region with evolving Regulatory landscape. All these timelines have kept the Regulatory professional on their toes. Post-Brexit, the first MHRA grace period for active implantable medical devices, Class III, Class IIb implantables, and IVD list A devices ended on April 30, 2021, and the second MHRA grace period for Class IIb non-implantables, Class IIa medical devices concluded on August 31, 2021. Now, the medical device industry is moving towards the third MHRA grace period due on December 31, 2021.
Since the end of the Brexit transition period on December 31, 2020, the UK MHRA has published updates like guidance for medical devices, templates for bulk uploads, obligations for importers, among others. In addition to these published updates, various unannounced updates are known to only the active stakeholders in the UK MHRA device registration. As a medical device or IVD device manufacturer exporting to the UK market, are you aware of these recent updates? Do you have an in-depth understanding of the below aspects.
Introduction to Regulatory Landscape in the UK
Landscape of Northern Ireland and the UK
Northern Ireland Protocol and the MHRA
Regulation of Device Products (MD & IVD) in the UK and the Approved Bodies
Compliance Routes to Market Medical Devices in Great Britain and Northern Ireland
Overview of the MHRA Registration Timelines
Grace Periods to Register with the UK MHRA
Regulatory Updates by the MHRA Post September 1, 2021, Transition Period
Recent Regulatory Updates Released by the UK MHRA Post 2nd grace period
Import Obligations of UKRP
Updates for the Importers by the MHRA
New Requirements/Regulations set by the UK MHRA
Do You Need Importer/Distributor?
Dos and Don’ts for an Importer
Certificate of Free Sales for non-UK manufacturers
Post Registration Activities for Manufacturers & UKRP
UKRP Challenges from Practical Scenarios
Learnings While Delivering the UKRP Projects
To navigate you through the ground-level dynamics and realities of the UK MHRA device registration, Freyr brings an exclusive webinar on “Medical Devices in the UK & UKRP: Latest Industry Updates,” scheduled on October 27, 2021. 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 current updates on device registration with the UK MHRA and UKRP. Register now to stay updated.