EU perspective on Medical Devices in 2021: Analysis of the NEW requirements by the MDR & BREXIT
*Industry Talks Sessions are part of the Omnia Health Live Americas virtual expo. To sign-up for this webinar please register for Omnia Health Live Americas.
Brought by:
Monday, November 2
02:00PM EST
Venue: Omnia Health Live Americas - Room 5
Overview
New UK Guidelines & MDR Timeline Explained!
2021 is expected to be a unique year by the coming into force of 2 major events within the sector of medical devices in the European Market:
January 1st 2021 - The final departure of the UK from the European single market (BREXIT)
May 26th 2021 - The coming into force of the NEW Medical Device Regulation (MDR).
The MHRA (UK Authority on medical devices) has recently published a guidance document covering the post-Brexit era, giving a new outlook of the long awaited UK regulations to be applied to medical device manufacturers wishing to place their devices on the UK market after January 1st. The MDR introduces a complete set of NEW requirements which require on average 18 months of preparatory work to achieve compliance – with only 6 months to the Date of Application (DoA), manufacturers must ensure they have taken all necessary actions.
Learning objectives
By the end of the session, participants will learn about:
- Overview of the NEW requirements by the MDR
- Key strategic points to achieve compliance with the MDR
- Overview of the NEW UK requirements (according to MHRA guidance)
- The tasks and responsibilities of the UK Responsible Person (UK RP)
- How to designate a UK Responsible Person?
Target audience
- Medical device and in-vitro diagnosticmanufacturers (SMEs)
- Business Development Managers
- Export Managers
- Regulatory Experts
- Founders
- Directors
Speaker
Doram Elkayam
COO
Obelis Group
Doram Elkayam’s career encompasses more than 20 years of professional experience focusing on leadership and higher management.
As Chief Operations Officer (C.O.O.) at Obelis for over a decade, he has gained in-depth legal and regulatory expertise in EU affairs with a special focus on medical devices and cosmetic products.
Being a strong advocate of education, lecturing at different events and providing
educational seminars belong to his daily activities. As part of Obelis’ vision
of creating compliance for safer markets, his passion is providing tailored
solutions to the needs of brand owners who wish to penetrate the European
Market.
Moderator
Bianca Sofian
Consultant Regulatory Affairs Department
Obelis Group
Bianca is a Regulatory Consultant within the VIP Clients Department at Obelis.
With a Bachelors degree in Law and an LLM in Law and Economics, Bianca has focused her professional career on the European legislation with a predilection to the internal market. She has activated both in the public and private sector prior
to joining Obelis and is now mostly working with the Medical Devices and Cosmetics Regulations.
Her legal background and multiple international experiences help her in managing a complex client portfolio and provide excellent regulatory service.
Industry Talks Sessions are part of the Omnia Health Live Americas virtual expo. To add this session to your calendar please register for Omnia Health Live Americas.
