We are delighted to see your interest in Freyr Webinar Series (FWS). The webinar on, “Medical Devices in UK & UKRP: Guidance for Non-UK Manufacturers, is scheduled on August 4, 2021, for AMR, EU & ROW regions.

What Is It All About?

It is well known that since January 1, 2021, medical device and IVD manufacturers willing to enter the UK market are obliged to follow a new Regulatory regime that is solely regulated by the MHRA. The new regulations include changes in CE marking and certification, UKCA mark, registration timelines for certain device classes and UKRP roles and responsibilities. To make you understand the new regulations comprehensively, here we bring you an exclusive webinar on:

Medical Devices in UK & UKRP:
Guidance for Non-UK Manufacturers

August 4, 2021

Duration – 45 Minutes

Join the Webinar at your Convenient Time

For Americas & EU

10.00 AM EDT | 4.00 PM CEST

For RoW Regions

1.30 PM IST

Host

Igor Dorosh

Associate Director - Business Development - Europe & Africa

Igor Dorosh comes with 8 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 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 medical device Regulatory landscape in UK and EU regions apart from her international expertise including Asia, Africa, Middle East, and South America.

In this webinar, our in-house Regulatory experts – Nisha Vempalle, Director - Medical Devices and Igor Dorosh, Associate Director - Business Development - Europe & Africa, will discuss about:

  • Regulatory Overview for Medical Devices & IVDs in the UK
  • Post-Brexit UK MHRA Requirements for Medical Devices
  • Registration Timelines with the MHRA for Class IIa, IIb and I Devices
  • Regulatory Updates for Class III Devices Post-Brexit Transition Period
  • UKRP - Roles and Responsibilities
  • Success Stories / Case studies
  • Q&A Session  

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