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UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course

What you need to know to gain market access in the UK

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

★★★★★ "Overall, I thought the webinar was presented and laid out well which was easy to follow. There were ... more"

3 Mar 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online
  • CPD: 6 hours for your records
  • Certificate of completion

Overview

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing.  The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.

The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.

This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

Benefits in attending

  • Understand the requirements to achieve UKCA
  • Know the differences between UKCA and CE marking
  • Learn how to align your conformity assessment procedures to meet UKCA and CE marking requirements
  • Consider the requirements for the Northern Ireland market

Who should attend

Medical device professionals who wish to gain knowledge and understanding of the new UKCA requirements

Regulatory affairs managers

Medical device manufacturers

Business development managers

Enrol or reserve

The UK Conformity Assessed (UKCA) Marking for Medical Devices course will cover:

Welcome and introduction

UKCA Marking and your legal obligations

  • The UK Medical Device Regulations explained
  • The use of standards in the UK
  • UK guidance for medical devices

UKCA Marking explained (placement of UK CA Mark)

  • Registering as a manufacturer to sell medical devices in the UK
  • Registering medical devices in the UK
  • The role of the UK Responsible person
  • UK Conformity Assessment Bodies

Technical Files and UK Declaration of Conformity

  • UKCA Technical File Versus EU Technical documentation, differences and similaraties
  • Aligning your conformity assessment procedures

UKNI Marking and the future

  • The process in Northern Ireland
  • Proposed future changes to UK regulations

Workshop - Case Study on obtaining the UKCA Mark

Case study on obtaining the UKCA Mark

Workshop feedback

Q & A

Enrol or reserve

Janette Benaddi

More details

Janette Benaddi

Janette Benaddi is an Independent Consultant and previously the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.

Janette has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

More details

Book UK Conformity Assessed (UKCA) Marking for Medical Devices Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

3 Mar 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12598

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 27 Jan

View basket 

 
Not ready to book yet?

for 7 days, no obligation

17 Jul 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12780

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 12 Jun

View basket 

 
Not ready to book yet?

for 7 days, no obligation

21 Nov 2023

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 12781

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 17 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's UK Conformity Assessed (UKCA) Marking for Medical Devices training course


Overall, I thought the webinar was presented and laid out well which was easy to follow. There were opportunities to ask questions and get involved throughout the webinar, not just in the breakout rooms. The content was informative and presented in well without being confusing unlike some of the guidance that is out there. Janette was great! Very friendly and informative with a lot of experience. I would definitely recommend the course to colleagues in the future.

Nov 3 2022

Lucy Haigh
Medical Device Officer, Northumbria Pharma Ltd

Nov 3 2022

I have been on courses before with Janette and was pleased to see she was presenting this course. Janette is very knowledgeable and provides a well structured course and an environment that allows participation throughout the session.

Stephen Rowe
Managing Director, SGR Consulting Services Ltd

Nov 3 2022

Very knowledgeable on the subject matter

Robert Johnson
Quality and Technical Manager, Northumbria Pharma Ltd

United Kingdom

  • Alliance Healthcare
  • Northumbria Pharma Ltd
  • Owen Mumford
  • Sanofi
  • SGR Consulting Services Ltd
  • Vernacare
  • VERNACARE LTD

Germany

  • BEGO Implant Systems GmbH & Co. KG

Netherlands

  • Merit Medical

Poland

  • Theramex HQ UK Limited

Spain

  • Grifols, S.A.

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy