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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.

★★★★★ "The course was very interesting and detailed. I'm very new to medical devices and I would have benef... more (13)"

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 2025 and 2026 including the new Post-market surveillance (PMS) regulation for medical devices in Great Britain (GB) which will come into force on the 16th June 2025, the challenges facing medical device companies, regulators and conformity assessment bodies are growing. The new requirements will impact technical documentation, labelling, logistics and regulatory compliance.

This course is part of our range of Medical Devices training courses

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:

UK Medical Device Regulation and your obligations

The UK medical device regulations explained
Transitional arrangements
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
New Post-market surveillance regulation for medical devices in Great Britain

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

Tina Amini

Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at bsi Notified Body, where she was responsible for Device Drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management System (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products.

Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry in a variety of disciplines where she took products through from discovery to commercialisation.

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

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

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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

The course was very interesting and detailed. I'm very new to medical devices and I would have benefitted from an introductory course first. However, I have the tools I need to find answers to questions I might have.

Jun 26 2025

Afi Sinclair United Kingdom
Regulatory Affairs Consultant, SincasPharma

Jul 17 2023

Very informative and covered everything we were expecting

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