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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.
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.
There are limited spaces on the introductory session. 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.
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
27 September 2023 | 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.
Module 2
6 November 2023 | 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
7 November 2023 | 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
8 November 2023 | 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
9 November 2023 | 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
10 November 2023 | 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
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.
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
15 September | 60 mins | 10:00 AM UK
Delivered Online
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
Day 1
9 November 2022
Introduction to the course, Medical Devices and the New MDR and IVDR
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
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.
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.
Day 2
10 November 2022
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
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
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
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
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.
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• 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.
