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Overview of EU Regulatory Affairs for Medical Devices

23 September 2024 | 1 Week Live Online Course

Original price was: £1,195.00.Current price is: £795.00.

(8 customer reviews)

The price is for all modules | Register for Online Module – Free

Gain a comprehensive overview of the Medical Device Regulatory Affairs in the EU (MDR) and UK to ensure compliance.

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Register For Module 1 | Free-To-Attend

 

Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

Register Early To Save

 

Enrol before 6 September To Save £400

Discount has been applied to the price above. VAT, if applicable, will be added.

Course Overview

 

Regulatory affairs is a critical function within the medical device sector to maintain patient safety. Regulatory requirements impact all areas of device development, so it is important for regulatory professionals to have a comprehensive understanding. In addition, the Medical Device Regulation (MDR) was introduced in Europe to replace the Medical Device Directive (MDD) to improve patient safety throughout Europe.

 

This course will provide you with a comprehensive understanding of the regulatory requirements from device classification and conformity assessment routes to clinical requirements and post market factors. You will develop a deep knowledge of the MDR and its impact throughout device development and distribution. The course will also fine tune your regulatory soft skills so you can continuously maintain your regulatory knowledge and perform with confidence.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver classroom and live online training.

Course Dates

 

Find out when this course is running so you can plan your training.

23 September 2024

1 Week Live Online Training
Register at the top of the page.

 

2025 Dates TBC

1 Week Live Online Training

Get in touch to register for these dates. The largest price saving of £400 will be applied.

Key Learning Objectives

 

  • Examine the role of key stakeholders including device manufacturers, distributors, Notified Bodies and Competent Authorities
  • Develop your regulatory skills so you know how to stay up-to-date with the latest guidelines and ISO standards
  • Understand the new regulatory requirements under the MDR to remain compliant in Europe
  • Learn how to classify your device with case study examples
  • Review the General Safety and Performance Requirements (GSPRs) for devices and the role of standards to demonstrate compliance
  • Examine the conformity assessment routes under the MDR to get your device certified in Europe
  • Understand the requirements for clinical evidence including clinical evaluations, investigations and Post Market Surveillance (PMS) and vigilance
  • Examine the importance of ISO 14971 device risk management and ISO 13485 Quality Management System (QMS)
  • Compare the latest UK requirements post Brexit to identify similarities and differences with the EU’s MDR

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

Frequently asked questions (FAQs)

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Online Module

FREE to Attend | Live & Recorded

22 August 2024 | 60 mins | 1:00 PM (UK)

Introduction to Medical Devices and the New MDR and IVDR

  • Definitions and actors
  • Competent Authorities and Notified Bodies
  • Economic operators – obligations of manufacturers, distributors, importers and authorised representatives
  • Placing on the market and enforcement
  • Introduction to the MDR & IVDR and reasons behind their development
  • Chief differences of MDR with MDD and impact of MDR on industry
  • What isn’t covered in the regulations?
  • Eudamed database/GMDN

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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Module 2

23 September 2024 | 120 mins | 1:00 PM (UK)

Medical Device Classifications

  • Review of definitions
  • Principles of classification – MDR – The 22 Classification Rules
  • Borderline determination
  • Risk classes and practical examples
  • Annex XVI devices
  • Examples of device classification

 

Classification Exercise
In groups you will apply the MDR classification rules to various medical devices to determine what class they are. Once completed you will discuss your answers with the class.

 

Conformity Assessment Routes

  • Examination of the possible conformity assessment routes
  • Analysis of the routes defined by the MDR
  • What is required for each Conformity Assessment Annex?
  • Additional scrutiny requirements under MDR
Module 3

24 September 2024 | 120 mins | 1:00 PM (UK)

General Safety and Performance Requirements

  • GSPRs – technical requirements – role of standards in demonstrating compliance with GSPRs
  • Chief differences with the MDD
  • Labelling requirements – impact of Unique Device Identification and registration on EUDAMED

 

GSPR Exercise
In groups you will examine a GSPR that is applicable to your device and complete the details of how you will meet it. Once completed you will discuss your answer with the class.

Module 4

25 September 2024 | 120 mins | 1:00 PM (UK)

Technical Documentation and other regulatory aspects of the QMS

  • Annex II of MDR – Technical file format / structure
  • Annex III – Post-Market Surveillance documentation
  • Good documentation practice
  • Inclusion of regulatory processes in the Quality Management System
  • Requirements for the Person Responsible for Regulatory Compliance
Module 5

26 September 2024 | 120 mins | 1:00 PM (UK)

Clinical Evaluation, Post Market Surveillance (PMS), Post-market Clinical Follow Up (PMCF) & Vigilance

  • Overview of the specific regulations and guidance
  • Definitions
  • Clinical evaluation process
  • PMCF within the context of clinical evaluation and PMS
  • Understanding the cyclical nature of post-market surveillance with all its interfaces
  • Post- market surveillance requirements and key output documents
  • Vigilance reporting requirements
Module 6

27 September 2024 | 120 mins | 1:00 PM (UK)

Risk Assessment and Management

  • Risk Management concept and EN ISO 14971:2019
  • Risk Management process and linkage of clinical evaluation, PMS with risk conclusions.
  • Key output documents
  • Risk Management Plan
  • Risk Benefit Analysis
  • Risk Management Report

 

Risk Assessment Exercise
Working in groups or individually you will examine your understanding of risk management by completing a case study exercise. Once completed you discuss your answers with the class.

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.

This course is suitable for professionals who work in or are new to the Medical Device industry and require a complete overview of the Medical Device Regulation (MDR). These include:

  • Regulatory Affairs
  • Quality
  • Design & Development
  • Clinical
  • Management
  • Device Manufacturers
  • Device Distributors
  • Pharmaceutical Professionals new to Device regulations
Free Online Module and Pricing

 

  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

 

Frequently asked questions (FAQs)

Could your team benefit from this course?

 

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Complete our contact form by following the link. Get in touch.

What is a Hybrid Training Course?

 

You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.

8 reviews for

Overview of EU Regulatory Affairs for Medical Devices

23 September 2024 | 1 Week Live Online Course

  1. Individual (verified owner)

    Excellent introductory course for EU MDR! Very well organized, comprehensive information, up to date, interactive, practical. Q&A sessions were very useful.

  2. Individual Booking (verified owner)

    n/a

  3. Andromedia Lean Consultants (verified owner)

    n/a

  4. OCCYO GmbH (verified owner)

    n/a

  5. Care Surgical (verified owner)

    n/a

  6. Labman Automation Ltd (verified owner)

    n/a

  7. Rocialle Healthcare

    Throughout the course I was asked if I had any questions or if I didn’t understand to point this out so it could be reiterated, I found this helpful. I found the course interesting and I learnt a lot. The course will help me a lot during my day-to-day duties in my work environment too.

  8. Naizak

    n/a

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