Register before 4 September to save 20% (Sep Course)
Discount has been applied to the price above. VAT, if applicable, will be added.
Sale
Navigating the UK Medical Device Regulations 2002 (as Amended)
29 September 2026 | Short Online Course
Original price was: £350.£280Current price is: £280.
1-Day Live Online training | Gain a clear understanding of the UK’s medical device regulations, including classification, UKCA marking, and post-market obligations
Learn more about the course by toggling through the tabs below.
Course Overview
The UK Medical Device Regulations 2002 (as amended) form the cornerstone of medical device compliance in Great Britain. Following Brexit, the regulatory framework has diverged from the EU MDR, introducing new requirements for UKCA marking, Approved Bodies, device registration, and the appointment of a UK Responsible Person.
This practical one-day course provides a clear and comprehensive overview of the UK regulatory landscape for medical devices. Participants will learn how to classify devices, select conformity assessment routes, prepare technical documentation, and understand manufacturer obligations for post-market surveillance and vigilance. Real-world examples and up-to-date guidance will help attendees confidently navigate the UK regulatory system and prepare for successful market access.
Key Learning Objectives
- Understand the structure and scope of the UK Medical Device Regulations 2002 (as amended).
- Classify medical devices under UK law and identify applicable conformity assessment routes.
- Recognise the roles of the MHRA, Approved Bodies, and UK Responsible Person.
- Understand UKCA marking requirements and transition timelines from CE marking.
- Learn how to register devices with the MHRA and maintain regulatory compliance.
- Understand the role of the UK Responsible Person
- Implement effective post-market surveillance and vigilance processes in line with recent amendments.
Who Should Attend?
This course is ideal for professionals working in or with the UK medical device market, including:
- Regulatory Affairs and Quality Assurance professionals
- Design and Development Engineers
- Clinical and Risk Management Specialists
- Manufacturing and Operations Managers
- Consultants supporting UKCA submissions
- Anyone seeking to understand post-Brexit medical device regulation in the UK
Course Outline
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
29 September 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
Introduction to the UK Medical Device Regulations 2002 (as Amended)
- The legal framework and structure of the UK MDR 2002
- Key definitions: medical device, intended purpose, classification
- Overview of amendments and the impact of Brexit
- Relationship between UK MDR, EU MDR, and Northern Ireland’s dual framework (Windsor Framework)
Device Classification and Conformity Assessment
- Overview of device classes and classification rules
- Determining the correct conformity assessment route
- Documentation requirements for different device classes
- Role of Approved Bodies and self-certification criteria
- Overview of technical documentation requirements
Session 2
120 mins | 10:00 AM UK
UKCA Marking and Device Registration
- UKCA marking requirements and transition from CE marking
- Timeline for CE acceptance in Great Britain
- MHRA registration process and required documentation
- Responsibilities of the UK Responsible Person
- Practical steps for UK market access
Post-Market Surveillance and Vigilance
- Overview of post-market obligations for manufacturers
- Vigilance reporting requirements and Field Safety Corrective Actions (FSCAs)
- Common MHRA findings and best practices for compliance
- Recent and upcoming regulatory amendments
Wrap-Up and Q&A
- Key takeaways and regulatory resources
Annette Callaghan is a quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
29 September 2026
1-Day Live Online Training
Register at the top of the page.
Course Times
For live online delivery, the course starts at 10:00 AM (UK time) and finishes at 3:00 PM (UK time).
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to 2 weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
Live Online
This course is delivered live online with direct access to the trainer.
4 Hours of Learning
This course includes a total of 4 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
Related products
-
Sale
This product has multiple variants. The options may be chosen on the product page
Original price was: £1,395.£995Current price is: £995.Labelling and UDI for Medical Devices and IVDs
23 March 2026 | 4-Day Live Online Course
-
This product has multiple variants. The options may be chosen on the product page
£895 £1,895Price range: £895 through £1,895Gathering Clinical Evidence for Medical Devices
11, 12 & 13 November 2025 | Hybrid Training | London
-
Sale
This product has multiple variants. The options may be chosen on the product page
Original price was: £595.£476Current price is: £476.PRRC Training (Person Responsible for Regulatory Compliance)
12 May 2026 | 1-Day Live Online Course
Reviews
There are no reviews yet.