The EU MDR: An Introductory Course

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This basic course/webinar offers an intensive deep dive into the drivers, impacts, and structure of the EU Medical Device Regulation (MDR). The course walks through the high-priority sections of the MDR that companies need to know in order to upgrade their quality systems and regulatory certifications for MDR compliance. Participants will gain the practical skills and critical knowledge needed to successfully comply with the MDR across the device's full lifecycle.

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This training takes place in one of two formats (your choice): 

• Three-day in-person training (8 hours/day) located at your site

• Five-day remote online training (4 hours/day)

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EU Medical Device Regulation Course Objectives:

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After taking this course, you will be able to:

• Define the structure of the EU MDR

• Explain key differences between the MDR and previous directives

• Explain how other international standards and guidance documents for medical devices relate to the MDR

• Explain the impact of the MDR on the MAID: Manufacturers, Authorized Representatives, Importers, Distributors

• Describe a device lifecycle from the perspective of the MDR

• Identify steps to prepare an organization to implement the EU MDR

• Create a gap analysis for your organization to analyze MDR compliance

 

Who should take this course?

• Regulatory professionals new to EU device regulation

• Team members that require proof of training in EU MDR (certificate awarded at end of course)

• Experienced device professionals looking to brush up on regulations

• Recommended for professionals in QA/RA, R&D, Marketing, Production Management, and any role associated with the device development and maintenance function

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Course Overview

 

Introduction to EU MDR (2017/745)

• Structure of EU government acts

• Directives vs. Regulations vs. Implementing Acts

• Major entities and roles under the MDR

• Drivers behind making the MDR

 

MDR Requirements for the Quality Management System (QMS)

• Impact of the MDR and ISO 13485:2016 on the QMS

• Differences in MDD vs MDR requirements

• Conforming to MDR and ISO

• Roles and responsibilities for an MDR-compliant QMS

 

Pre-market Activities for Medical Devices

• Risk-based device classification under MDR

• Classification rules in MDR Annex VIII

• Conformity assessment routs in MDR Annexes IX through XI

• High-risk device requirements

• Workshop: Classify a medical device

 

Technical Documentation under MDR

• Technical Documentation definitions

• Structure/contents of Technical Documentation

• The General Safety & Performance Requirements (GSPRs)

• Common specifications (CS) and harmonized standards

• Introduction to device lifecycle management

 

Clinical Evaluation

• Using MEDDEV 2.7/1 Rev 4 guidance for MDR compliance

• Clinical evaluation under the MDR

• Clinical investigations under the MDR

• The Clinical Evaluation Report

• Post-market Clinical Follow-up

• Workshop: Sketch a Clinical Evaluation Plan

 

Unique Device Identification (UDI)

• UDI traceability requirements under MDR

• Impacts of UDI for economic operators (MAID)

• EUDAMED - the electronic MDR database environment

 

Post-market Device Management

• Post-market Surveillance (PMS) requirements under MDR

• Vigilance / trend reporting

• Dealing with serious incidents and field safety actions

• EUDAMED in PMS

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Impact of MDR on Auditing

• Notified Body requirements under MDR

• Types of Notified Body audits under MDR

  • QMS audits​

  • Technical Documentation audits

  • Surveillance Audits

  • Unannounced Audits

  • Other conformance routes

• Receiving a CE Mark

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Compliance with MDR in an Organization

• Preparing to comply

• The internal audit function and planning

• Best practices for implementation​

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