We are delighted to see your interest in Freyr Webinar Series (FWS). The webinar on “Medical Devices in the UK & UKCA Certification Readiness” is scheduled for May 25, 2022.

What Is It All About?

Post-Brexit, the Medicines and Healthcare Products Regulatory Agency (MHRA) has set up a Regulatory framework for the medical devices placed in the UK market. The manufacturers are required to conform to the MHRA regulations and affix the UK Conformity Assessment (UKCA) mark to place their medical devices in Great Britain (England, Scotland, and Wales) market.

As a medical device and IVD manufacturer exporting to the UK, are you aware of the timelines, routes, and next steps for UKCA marking? To help you understand the current practical considerations of the UK device registrations and UKCA marking, Freyr brings you an exclusive on-demand webinar.

Medical Devices in the UK & UKCA Certification Readiness

May 25, 2022

Duration – 45 Minutes

Join the Webinar at your Convenient Time

For AMR and EUA Regions

11:00 AM EDT | 05:00 PM CEST

For RoW Region

01:30 PM IST

Host

Igor Dorosh

Associate Director, Business Development – Europe & Africa

Igor Dorosh comes with eight (08) years of experience in the Pharmaceutical industry. He is a strong sales professional, skilled in market access analysis, Regulatory Affairs & pharmacovigilance outsourcing optimization for the EU and emerging markets. Igor is currently working with Freyr Solutions as Associate Director, Business Development - Europe & Africa, and is driving business development ventures.

Presenter

Nisha Vempalle

Director - Medical Devices

Nisha Vempalle leads medical devices Regulatory operations in the UK and EU in Regulatory readiness, strategic planning, and spearheads project delivery. She has more than 15 years of experience across Regulatory affairs- delivering global innovation projects, Regulatory strategies, leading Regulatory projects to successful approvals, and launch of medical devices. Her core strength is the deep understanding of the medical device Regulatory landscape in the UK and EU regions apart from her international expertise, including Asia, Africa, Middle East, and South America. She has a wealth of experience from her previous roles at PAGB, GlaxoSmithKline, and Biocon, spanning more than a decade. Nisha is a Pharmacist and holds a master's degree in Pharmaceutical sciences from Kingston University, and is a RAC-EU & global certified professional.

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 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
  • Q&A

Given the keynotes and with due respect to your busy schedule, we look forward to seeing you in the webinar. Register now! Stay informed. Stay compliant.