Presented by
Management Forum
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.
★★★★★ "Very informative and covered everything we were expecting"
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
- Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
- UK Conformity Assessed (UKCA) Marking for Medical Devices
- Sterilization of Medical Devices
- An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
- Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
- Non-Conformance and Corrective Action for Medical Device Manufacturers
Overview
Since 1 January 2021, there have been a number of changes to how medical devices are placed on the market in the UK. , With a substantial reform of the current UK regulatory framework for medical devices in July 2025, 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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
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
Janette Benaddi
Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 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. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she 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.
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
1 March 2024
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 13576
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 26 Jan
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
15 July 2024
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 13827
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 10 Jun
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
19 November 2024
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 14049
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 15 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
Very informative and covered everything we were expecting
Jul 17 2023
Massimo Di Domenico 
Director, Burnshield (Pty) Ltd
Jul 17 2023
I think the webinar is well executed.
Massimo Di Domenico
Director, Burnshield (Pty) Ltd
Jul 17 2023
extremely satisfied with all.
Anne-Marie Spence 
Vascular Clinical Specialist EMEA, Argon Medical
Mar 3 2023
Thank you for a great course. Great presentation style . it followed a balance of content and workshop. Tina allowed participants to make their contributions for all aspects of training.
Afsaneh Jafari
Quality Manager, Eurofins E&E CML
Mar 3 2023
Very good and easy to understand
Cheryl O'Rourke
Head of Medical Devices UK,
Mar 3 2023
Very good and easy to understand
Cheryl O'Rourke
Head of Medical Devices UK,
Nov 3 2022
I found the session very informative and good value for money. It was a shame the group was not a little bigger to incorporate some additional experience and diversity but that is largely out of the control of IPI.
Stephen Rowe
Managing Director, SGR Consulting Services Ltd
Nov 3 2022
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.
Lucy Haigh
Medical Device and Cosmetic 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
- Argon Medical
- Bedfont Scientific Ltd
- Devicepharm Consultancy Limited
- Eurofins
- Eurofins E&E CML
- Eurofins E&E CML Limited
- Northumbria Pharma Ltd
- Owen Mumford
- Pathaway Services Ltd
- Sanofi
- SGR Consulting Services Ltd
- Swallow Dental Supplies
- Vernacare
- VERNACARE LTD
Poland
- LiNA Medical Polska Sp. z o.o.
- Theramex HQ UK Limited
Switzerland
- Haemonetics S.A.
- Siemens Healthineers International AG
Belgium
- Nikkiso Belgium
France
- Septodont
Germany
- BEGO Implant Systems GmbH & Co. KG
Netherlands
- Merit Medical
South Africa
- Burnshield (Pty) Ltd
Spain
- Grifols, S.A.
Sweden
- Nordeberg Medical AB
