Understanding the EU MDR
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1. Introduction

Introduction to the MDR
Supporting Information - Understanding the EU MDR
Structure of the MDR
MDR requirements
What is a medical device
2. Understanding requirements

Classifying medical devices
Making devices available on the market
General Safety and Performance Requirements (GSPRs)
3. QMS, PMS & Risk Management

Quality Management Systems & Post-Market Surveillance
Basic principles of Risk Management
Benefits of Risk Management
4. Clinical Evaluation

Clinical Evaluation & CERs
Basic principles of planning a CER
5 common pitfalls for a CER
Our Clinical Evaluation services
5. Gap Analysis & Document Management

Gap Analysis Tool
Document Management
Importance of Document Management

1. Introduction

This section lays the foundations for more detailed considerations which follow. It provides an overview of the EU MDR, its structure, and the main requirements it imposes on manufacturers. It also considers which types of products fall within its legislative reach.

5 Lessons