Quality System Requirements for Medical Devices

Reference Guide
For
Manufacturers Selling Medical Devices in Europe,
Canada and the United States

2005 Version

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Industry Canada
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© Industry Canada, 2005

Cat. No. Iu44-23/2005E-PDF
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Aussi disponible en français sous le titre Exigences en matière de système qualité pour les dispositifs médicaux: Manuel de référence à l'intention des fabricants qui vendent des dispositifs médicaux en Europe, au Canada et aux États-Unis - Version 2005. Une version électronique du document français est disponible à l'adresse suivante : http://strategis.gc.ca/appmed.

Table of Contents

     An Overview of the Quality Requirements for the Sale of Medical Devices in Europe

1. Key Elements of the MDD and IVD MDD
   1.1 Essential Requirements

   1.2 Product Class

   1.3 Conformity Assessment Routes

   1.4 Technical Documentation

   1.5 Declaration of Conformity

   1.6 Postmarket Surveillance

   1.7 Vigilance Reporting

   1.8 European Authorized Representative

2. Six Steps to Acquiring the CE Marking under the MDD
   2.1 Classify Your Product

   2.2 Select the Best Conformity Assessment Route

   2.3 Apply for Registration

   2.4 Provide Technical Documentation

   2.5 Make Declaration of Conformity

   2.6 Affix the CE Marking

3. What Each Step Involves
   3.1 Classifying Your Product

   3.2 Choosing the Conformity Assessment Route

   3.2.1 Class I Device

   3.2.2 Class IIa Device

   3.2.3 Class IIb Device

   3.2.4 Class III Device

   3.3 The Registration Process

   3.3.1 Selecting a Notified Body

   3.3.2 The Process

   3.3.3 Registration Cost

   3.4 Technical Documentation

   3.4.1 Quality System Documentation

   3.4.2 Product Documentation

   3.4.3 Location of Technical Documentation

   3.5 Declaration of Conformity

   3.6 Affixing the CE Marking

4. Six Steps to Acquiring the CE Marking under IVD MDD
   4.1 Classify Your Product

   4.2 Select the Best Conformity Assessment Route

   4.3 Apply for Registration

   4.4 Provide Technical Documentation

   4.5 Make Declaration of Conformity

   4.6 Affix the CE Marking

5. What Each Step Involves
   5.1 Classifying Your IVD

   5.2 Choosing the Conformity Assessment Route

   5.2.1 Other IVDs

   5.2.2 Self-test IVDs

   5.2.3 Annex II List B IVDs

   5.2.4 Annex II List A IVDs

6. Other Features of the CE Marking Process
   6.1 Postmarket Surveillance and Vigilance Reporting

   6.2 European Authorized Representative

   6.3 Labeling

7. Information Sources

Chapter 2: Canadian Requirements

     An Overview of the Quality System Requirements for the Sale of Medical Devices in Canada

1. Key Elements of the Medical Devices Regulations
   1.1 Scope of Application

   1.2 Medical Device and In Vitro Diagnostic Device Classification

   1.3 General Requirements

   1.3.1 Safety and Effectiveness Requirements

   1.3.2 Medical Device Licence

   1.3.3 Establishment Licence

   1.3.4 Labelling Requirements

   1.3.5 Distribution Records

   1.3.6 Mandatory Problem Reporting

   1.3.7 Recall

   1.3.8 Implant Registration

   1.4 Custom-Made Devices and Medical Devices to be Imported or Sold for Special Access

   1.5 Medical Devices for Investigational Testing

   1.6 Export Certificates

2. Quality System Requirements
   2.1 Policy on the Canadian Medical Devices Conformity Assessment System (CMDCAS)

   2.2 Registering the Quality System

   2.2.1 The Process

   2.2.2 Registration Cost

3. Information Sources

   
   

Chapter 3: US Requirements

     An Overview of the Quality System Requirements for Medical Devices Manufactured, Imported, or Offered for Import in the US

Introduction

1. Key Elements of the FDA Regulations
   1.1 Device Classification

   1.2 General Controls

   1.2.1 Establishment Registration

   1.2.2 Device Listing

   1.2.3 Premarket Notification (510(k))

   1.2.4 Good Manufacturing Practices (GMP) Regulation

   1.3 Investigational Device Exemption (IDE)

   1.4 Premarket Approval

   1.5 Safe Medical Devices Act (SMDA) of 1992 and FDA Modernization Act (FDAMA) of 1997 and Medical Device User Fee and Modernization ACt (MDUFMA) of 2002

   1.5.1 Medical Device Reporting

   1.5.2 Tracking Requirements

   1.5.3 Removals and Corrections

   1.5.4 Postmarket Surveillance

   1.5.5 General Information on FDAMA and Third-Party Review

   1.5.6 General Information on MDUFMA

        Identification of Device Manufacturer

2. Quality System Regulation
   2.1 FDA Inspections

3. Information Sources

Summary

Appendix 1: Example of European Risk Classes of Medical Devices

Appendix 2: Questions for the Notified Body/Registrar

Appendix 3: Content of a Design Dossier

Appendix 4: EUCOMED Guidance Notes on the Interpretation of the Essential Requirements

Appendix 5: List of Important Documents and Standards

Appendix 6: Comparison Chart of ISO 13485:1996, ISO 13485:2003 and FDA's QSR and EN 46001

Appendix 7: Canadian Firms and the Small Business Discount for the Review of Medical Devices Under the Medical Device User-Fee and Modernization Act of 2002 (MDUFMA)

Glossary of Terms Used in the Field of Medical Device Regulation