Bringing Medical Devices to the UK Market After Brexit

1.5
RAC Credits
Wednesday, 24 March 2021 (10:00 AM) - Wednesday, 24 March 2021 (11:30 AM) Eastern Time (US & Canada)

Staying compliant in Post-Brexit Great Britain requires a thorough understanding of the guidances issued by the MHRA and careful navigation of changing regulatory landscape. Since the EU MDR and EU IVDR don’t automatically apply, RA professionals need to thoroughly understand the new regulatory framework route to market using Great Britain’s UK CA mark or UK NI mark and how new regulations vary across Britain’s provinces. This program will cover how to interpret the numerous MHRA guidance documents and more after the Brexit transition period.

Described as a think tank, where collaboration rules, Solutions Circles are where regulatory professionals will be able to come together with the highest form of collaboration. Popularized at RAPS Convergence, Solutions Circles allow you to bounce ideas off colleagues and examine regulatory challenges.

    By the end of this session, you will be able to:
  • Identify the UK MHRA requirements associated with the Post-Brexit transition period.
  • Ask critical questions of your senior leaders about the Quality Planning for fulfillment of the applicable regulatory requirements associated with the UK and EU after Brexit.
  • Recognize the need to stay tuned to upcoming developments on this topic.

Pricing Amounts & Deadlines

5 February 2021 – 23 March 2021: Member $160 | Nonmember $175


Speakers

Kim Trautman, M.S. Executive Vice President, Medical Device International Services

Kim Trautman is an experienced Medical Devices and In Vitro Diagnostics Executive Vice President with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.


Robert van Boxtel, Medical Device Project B.V.

Robert van Boxtel is Principal Consultant and management team member at Medical Device Project B.V. in the Netherlands. For more than 10 years, he supports the medical device industry with QA and RA related consultancy, focusing on the EU and USA. Additionally, he provides training to the industry, Notified Bodies and Competent Authorities on EU MDR, ISO 13485, Risk Management, auditing etc. He is hired by the Dutch Standards Institute (Royal NEN), as SME for training on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on quality management systems, risk management, PMS and is member of the Dutch horizontal standards committee.

Robert is Board Member of both the RAPS Netherlands Chapter and the RAPS European Council.

Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (now Dekra Certification) and in the medical device industry in several roles in design and production, both in the EU and the USA. As a result he has over 25 years of experience in the medical device industry.


Steve McRoberts, CPhys MInst, Chief Risk Officer (Technical) LumiraDX

Steve McRoberts has worked with medical devices and in vitro diagnostic products for more than 26 years as a test engineer, medical device designer, and regulatory and industry executive. He started his career in device testing and certification, and has conducted nearly 1,000 certification projects. McRoberts also was head of two different notified bodies covering the EU directives on devices and IVDs. He is an experienced auditor for ISO 13485 and medical devices regulatory QMS programs, including CMDCAS, European Notified Body, Japan 3rd Party Program and MDSAP. He was a member of the CMDCAS regulators forum from 2004 to 2015, helping to shape the Canadian regulatory program and transforming it to MDSAP. He has been an active contributor to numerous international working groups and technical committees. McRoberts has provided expert input, training and consulting on the development of medical device and IVD regulations to multiple national governments.



Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

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