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.
★★★★★ "Thank you for a great course. Great presentation style . it followed a balance of content and works... more"
17 July 2023
+ 21 November 2023
from £549
- 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.
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:
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
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.
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
17 July 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
- 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
21 November 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 12781
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 17 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
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.
Mar 3 2023
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
- Eurofins
- Eurofins E&E CML
- Eurofins E&E CML Limited
- Northumbria Pharma Ltd
- Owen Mumford
- Sanofi
- SGR Consulting Services Ltd
- Swallow Dental Supplies
- Vernacare
- VERNACARE LTD
France
- Septodont
Germany
- BEGO Implant Systems GmbH & Co. KG
Netherlands
- Merit Medical
Poland
- Theramex HQ UK Limited
Spain
- Grifols, S.A.
Sweden
- Nordeberg Medical AB
Switzerland
- Siemens Healthineers International AG
