Guidances


 In this section we provide an extended list of key guidances on Medical Devices compliance related aspects:

  GHTF Guidance

GHTF Study Group 1 - Pre-market Evaluation   

 

      
Principles of Conformity Assessment for Medical Devicespdf(382 KB)  
November 2012 
Principles of Medical Devices Classificationpdf(772 KB)  
November 2012

Essential Principles of Safety and Performance of Medical Devicespdf(446 KB)  
November 2012

Label and Instructions for Use for Medical Devicespdf(129 KB)  
September 2011
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devicespdf(157 KB)  
March 2011
Registration of Manufacturers and other Parties and Listing of Medical Devicespdf(106 KB)  
August 2010
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devicespdf(87 KB)  
July 2008
Role of Standards in the Assessment of Medical Devicespdf(128 KB)  
March 2008
Principles of In Vitro Diagnostic (IVD) Medical Device Classificationpdf(199 KB)  
February 2008
GHTF Study Group 2 - Post-market Surveillance/Vigilance 

XML Schema for Electronic Transfer of Adverse Event Datapdf(355 KB) (18 KB)

July 2012

National Competent Authority Report Exchange Programpdf(59 KB)  
July 2009
Medical Devices Post Market Surveillancepdf(142 KB)  
February 2009
Guidance - Content of Field Safety Noticepdf(58 KB)  
June 2006
 
Review of Requirements on Post-market Surveillancepdf(187 KB)  
May 2005
Where to Send Adverse Event Reportspdf(204 KB)  
May 2005
 
PMS Harmonization Chartpdf(51 KB)  
November 2004
Reporting of Use Errors with Medical Devices by their Manufacturerpdf(622 KB)  
February 2003
GHTF Study Group 3 - Quality Systems Guidance on Quality Systems for the Design and Manufacture of Medical Devicespdf(132 KB)  
June 1999
Design Control Guidance for Medical Devices Manufacturerspdf(125 KB)  
June 1999
GHTF Study Group 4 - Auditing Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirementspdf(159 KB)  
August 2008
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategypdf(193 KB)  
August 2010
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reportspdf(138 KB)  
October 2007
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditingpdf(157 KB)  
August 2010
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of Manufacturer Control of Supplierspdf(96 KB)  
August 2010
Training Requirements for Auditorspdf(41 KB)  
February 2000
GHTF Study Group 5 - Clinical Safety/Performance Clinical Evidence for IVD Medical Devices - Key Definitions and Conceptspdf(311 KB)  
November 2012
Clinical Evidence for IVD Medical Devices - Scientific Validity Determination and Performance Evaluationpdf(746 KB)  
November 2012
Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devicespdf(419 KB)  
November 2012

Reportable Events During Pre-Market Clinical Investigationspdf(196 KB)  

 August 2012

Post-Market Clinical Follow-Up Studiespdf(81 KB)  

February 2010

Clinical Investigationspdf(85 KB)  

February 2010

Clinical Evaluationpdf(604 KB)  

May 2007

Clinical Evidence - Key Definitions and Conceptspdf(595 KB)  

May 2007

   MEDDEV Guidance

 2.1 Scope, field of application, definition      MEDDEV 2.1/1pdf(19 KB) Definitions of "medical devices", "accessory" and "manufacturer"  
April 1994
MEDDEV 2.1/2 rev.2pdf(14 KB) Field of application of directive "active implantable medical devices" 
April 1994
MEDDEV 2.1/2.1pdf(12 KB) Field of application of directive "active implantable medical devices" 
February 1998
MEDDEV 2.1/3 rev.3pdf(182 KB)  Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative 
December 2009
MEDDEV 2.1/4pdf(21 KB) Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective  equipment 
March 1994
MEDDEV 2.1/5pdf(10 KB) Medical devices with a measuring function 
June 1998
MEDDEV 2.1/6pdf(323 KB) Qualification and Classification of stand alone software 
January 2012
2.2 Essential requirements MEDDEV 2.2/1 rev.1pdf(16 KB) EMC requirements 
February 1998
MEDDEV 2.2/3 rev.3pdf(17 KB) "Use by" - date
June 1998
MEDDEV 2.2/4pdf(39 KB) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
January 2012
2.4 Classification of MD

MEDDEV 2.4/1 rev.9pdf(654 KB) Classification of medical devices

June 2010

2.5 Conformity assessment procedure General rules
MEDDEV 2.5/3 rev.2pdf(9 KB) Subcontracting quality systems related
June 1998
MEDDEV 2.5/5 rev.3pdf(7 KB) Translation procedure
February 1998
MEDDEV 2.5/6 rev.1pdf(10 KB) Homogenous batches (verification of manufacturers' products)
February 1998
Conformity assessment for particular groups of products
MEDDEV 2.5/7 rev.1pdf(93 KB) Conformity assessment of breast implants
July 1998
Evaluation of medical devices incorporating products of animal origin. (See MEDDEV 2.11/1 rev.2pdf(82 KB))
MEDDEV 2.5/9 rev.1pdf(97 KB) Evaluation of medical devices incorporating products containing natural rubber latex
February 2004
MEDDEV 2.5/10 pdf(78 KB) Guideline for Authorised Representatives
January 2012  
2.7 Clinical investigation, clinical evaluation MEDDEV 2.7/1 rev.3pdf(378 KB) Clinical evaluation: Guide for manufacturers and notified bodies
December 2009
Appendix 1: Cinical evaluation on coronary stentspdf(101 KB)

December 2008
MEDDEV 2.7/2pdf(37 KB) Guide for Competent Authorities in making an assessment of clinical investigation notification
December 2008
MEDDEV 2.7/3pdf(166 KB) Clinical investigations: serious adverse event reporting - SAE reporting formexcel8book(87 KB)
December 2010
MEDDEV 2.7/4pdf(180 KB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies
December 2010
2.10 Notified bodies MEDDEV 2.10/2 rev.1pdf(105 KB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices
Annex 1pdf(120 KB)Annex 2pdf(14 KB)Annex 3pdf(17 KB)Annex 4pdf(26 KB)
April 2001
2.11 Products using materials of biological origin MEDDEV 2.11/1 rev.2pdf(82 KB) Application of Council Directive 93/42/EEC taking into account the Commission Directive 2003/32/EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected
Annex 1msw8(42 KB)
January 2008
2.12 Market surveillance MEDDEV 2.12/1 rev.8pdf(745 KB) Medical Devices Vigilance System  
January 2013                                                                                  
MEDDEV 2.12/2 rev.2 pdf(221 KB) Post Market Clinical Follow-up  studies
January 2012  
2.13 Transitional period MEDDEV 2.13 rev.1pdf(13 KB) Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) 
August 1998
2.14 IVD MEDDEV 2.14/1 rev.2pdf(75 KB) Borderline and Classification issues. A guide for manufacturers and notified bodies
January 2012
MEDDEV 2.14/2 rev.1pdf(64 KB) Research Use Only products
February 2004
MEDDEV 2.14/3 rev.1pdf(80 KB) Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices
January 2007
MEDDEV 2.14/4pdf(115 KB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
January 2012
2.15 Other guidances MEDDEV 2.15 rev.3pdf(33 KB) Committees/Working Groups contributing to the implementation of the Medical Device Directives
December 2008

  FDA Guidances

FDA Guidance - 2013    Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" - Draft Guidance for Industry and Food and Drug Administration Staffpdf(522 KB)  
April 2013

FDA Guidances - 2011   Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]  
December 2011
 
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design  
June 2011
Draft Guidance for Industry and Food and Drug Administration Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling  
May 2011 
FDA Guidance - 2008 Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile 
December 2008
FDA Guidances - 2005 Guidance for Industry and Food and Drug Administration Staff - Format for Traditional and Abbreviated 510(k)s 
August 2005
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 
May 2005
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing OFF-the-Shelf (OTS) Software 
January 2005
FDA Guidances - 2002   Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1) 
December 2002 
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA 
August 2002
General Principles of Software Validation; Final Guidance for Industry and FDA Staff 
January 2002
FDA Guidance - 2001  Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff 
May 2001
FDA Guidance - 2000  Guidance for Industry and for FDA Staff: Use of Standards in Substantial Equivalence Determinations 
March 2000 
FDA Guidance - 1999  Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 
September 1999 

  Canadian Legislation

Health Canada Guidance - 2013 Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices 
April 2013
Health Canada Guidance - 2012 Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) 
July 2012
Health Canada Guidances - 2011 Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence 
December 2011 
Guidance Document - Preparation of the Summary Technical Documentation (STED) - based Class III and Class IV Premarket Medical Device Licence Applications 
November 2011  
Guidance for the Interpretation of Significant Change of a Medical Device 
June 2011 
How to Complete the Application for a New Medical Device Licence 
March 2011 
Private Label Medical Devices: Questions and Answers 
March 2011 
Guidance Document - Private Label Medical Devices 
March 2011 
Health Canada Guidances - 2006 Notice: Updated Guidance on the Recognition and Use Of Standards under the Medical Device Regulations 
September 2006 
Guidance Document: Recognition and Use of Standards under the Medical Device Regulations 
September 2006
Health Canada Guidances - 1999 Preparation of an Application for Investigational Testing - Medical Devices V.3 
February 1999
Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices (IVDD) V.3 
February 1999 
Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications V.2 
February 1999 
Health Canada Guidances - 1998 Guidance for the Labelling of In Vitro Diagnostic Devices - DRAFT 
June 1998 
Guidance for the risk based classification system - DRAFT 
May 1998 
Guidance for the risk based classification system of in vitro diagnostic devices - DRAFT 
April 1998 

Note: Please note that the above references are only a selection of the guidances published by National Health autorities. Additional guidances may be applicable for your product. For a complete evaluation of the applicable legislation please contact us.