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

This course provides 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.

★★★★★ "Very informative and covered everything we were expecting"

26 June 2025
+ 21 October 2025 »
from £649

Need help? Enrol/reserve

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

Course 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.

This course is part of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of 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/reserve

This course will cover:

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 similarities
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

Workshop feedback

Q&A

Enrol/reserve

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.

More details

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

26 June 2025

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 14837

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 22 May

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

View basket

Not ready to book yet?

for 7 days, no obligation

21 October 2025

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 15077

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 16 Sep

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

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; and apply only when booking multiple delegates on the same date.

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 South Africa
Director, Burnshield (Pty) Ltd

Jul 17 2023

I think the webinar is well executed.

Massimo Di Domenico South Africa
Director, Burnshield (Pty) Ltd

Jul 17 2023

extremely satisfied with all.

Anne-Marie Spence United Kingdom
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 United Kingdom
Quality Manager, Eurofins E&E CML

Mar 3 2023

Very good and easy to understand

Cheryl O'Rourke United Kingdom
Head of Medical Devices UK,

Nov 21 2023

I was hoping to get more information on how to get an UKCA marking from a Medical Affairs point of view. I accomplished this.

Inès Simoes Garcez Palha France
Rédacteur Médical, Septodont

Mar 3 2023

Very good and easy to understand

Cheryl O'Rourke United Kingdom
Head of Medical Devices UK,

Mar 3 2023

Very good and easy to understand

Cheryl O'Rourke United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
Managing Director, SGR Consulting Services Ltd

Nov 3 2022

Very knowledgeable on the subject matter

Robert Johnson United Kingdom
Quality and Technical Manager, Northumbria Pharma Ltd

United Kingdom