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

13 February 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.

Module 2

18 March 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

19 March 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

20 March 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

21 March 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

22 March 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.