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.
13 Jul 2022 + 2 more dates
- 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
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 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.
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*
13 Jul 2022
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 12596
- GBP 499 599
- EUR 719 859
- USD 814 970
Until 08 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
3 Nov 2022
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 12597
- GBP 499 599
- EUR 719 859
- USD 814 970
Until 29 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
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 499 599
- EUR 719 859
- USD 814 970
Until 27 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
* 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.
