Register before 13 February to Save 20% (March Course)
Discount has been applied to the price above. VAT, if applicable, will be added.
Sale
Compliance Essentials for Distributors and Importers of Medical Devices and IVDs
3 March 2026 | Short Online Course
Original price was: £350.£280Current price is: £280.
Learn exactly what distributors and importers must do to ensure medical devices and IVDs are compliant — practical, clear, and aligned with EU MDR, IVDR and UK MDR requirements
Learn more about the course by toggling through the tabs below.
Course Overview
Distributors and importers play a critical role in ensuring medical devices and IVDs placed on the UK and EU markets comply with regulatory requirements. Under the EU MDR/IVDR and UK MDR frameworks, economic operators have clearly defined legal responsibilities relating to verification, documentation control, product traceability, complaint handling, and post-market surveillance.
This focused course provides distributors, importers, and own-brand labellers with a clear, practical understanding of their regulatory obligations. Participants will learn how to verify conformity, assess technical documentation, interpret labelling and certification, and manage compliance throughout the supply chain. The course also examines the complexities of placing products on the markets of Great Britain, Northern Ireland, and the EU, and includes a practical workshop using real product documentation and registration databases.
Key Learning Objectives
- Identify medical devices, IVDs and borderline products across EU and UK regulatory scopes
- Understand the legal responsibilities of distributors and importers, and how these differ from manufacturers and authorised representatives
- Fully understand the concept of ‘own-brand labeler’
- Verify product compliance by checking labelling, certificates, Declarations of Conformity and registration status
- Recognise key elements of classification and conformity assessment, including the role of Notified Bodies
- Perform post-market duties, including complaint handling and information reporting
- Apply regulatory requirements to real cases using practical documentation reviews and database searches
Who Should Attend?
This course is designed for professionals involved in the supply, importation, distribution or retail of medical devices and IVDs, including:
- Distributors and wholesalers
- Importers and logistics providers
- Retailers and e-commerce suppliers
- Own-brand labellers / private-label manufacturers
- Quality and Regulatory personnel in commercial organisations
- Consultants supporting supply chain compliance
- Anyone newly responsible for ensuring products placed on the UK or EU market meet regulatory requirements
Course Information
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
3 March 2026 | 27 October 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
Identifying medical devices & understanding the actors involved
- Recognising a medical device. Definition of a medical device and an IVD device and an accessory
- Understanding the borderlines with other products e.g. cosmetics / food supplements
- Scope of the regulations – EU and UK
Roles of different economic operators in EU & UK
- Concept of ‘own-brand labeler’
- Responsibilities of distributors – EU vs UK
- Responsibilities of importers – EU vs UK
- Role of Authorized Representative / UK Responsible Person / Person Responsible for Regulatory Affairs (PRRC) – EU only
- Examine complexity of import / export situation in UK, GB, NI and ROI
Session 2
120 mins | 1:00 PM UK
Regulatory compliance process
- Brief overview of what manufacturers have to do to place medical devices on market
- Classification of medical devices and IVDs
- Conformity Assessment – Role of Notified Bodies – Selection and changing of Notified Bodies – especially impact on labelling
- Understanding types of certification – CE marking versus ISO 13485 etc
- Technical Files – overview of contents / how to review
- Declaration of Conformity – Purpose and example
- Packaging & labelling content requirements for medical devices
Post-market surveillance
- for manufacturers and retailers
- Retailer complaint handling – importance of identifying information which must be communicated to supplier or competent authorities
Registration processes
- Registration process for EU and UK
Workshop
Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems. Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager.
Anne has run her own consultancy business since 2000 providing medical device regulatory support to companies ranging from research institutes and start-up companies to SMEs and multi-national market leaders. Anne was one of the founders and visiting lecturers to the MSc in Medical Technology Regulatory Affairs run by TOPRA and Cranfield University where she was also external examiner from 2009 to 2012.
Anne has extensive MDR expertise, supporting her clients transition from the MDD as new guidelines and ISO standards are published. As a result, she can draw on multiple case study examples and experience when delivering MDR training courses. Anne has led both in-house and public courses on medical device EU regulatory affairs for several years.
Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
3 March 2026
1-Day Live Online Training
Register at the top of the page.
27 October 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 two 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.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
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.
You may also like…
-
This product has multiple variants. The options may be chosen on the product page
£595Fundamentals of the EU IVD Regulation (IVDR)
On-Demand | 12 Hours of Learning
Related products
-
Understanding Pharmaceutical Licensing
Register Your Interest
-
Clinical Trial Optimisation for Excellent Delivery
Register Your Interest
-
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
Reviews
There are no reviews yet.