Source: http://medidee.com/index.php/resources/guidances
Timestamp: 2018-01-23 09:38:45
Document Index: 251878150

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 1']

In this section we provide an extended list of key guidances on Medical Devices compliance related aspects:
Principles of Conformity Assessment for Medical Devices (382 KB)
Principles of Medical Devices Classification (772 KB)
Essential Principles of Safety and Performance of Medical Devices (446 KB)
Label and Instructions for Use for Medical Devices (129 KB)
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices (157 KB)
Registration of Manufacturers and other Parties and Listing of Medical Devices (106 KB)
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices (87 KB)
Role of Standards in the Assessment of Medical Devices (128 KB)
Principles of In Vitro Diagnostic (IVD) Medical Device Classification (199 KB)
XML Schema for Electronic Transfer of Adverse Event Data (355 KB) (18 KB)
National Competent Authority Report Exchange Program (59 KB)
Medical Devices Post Market Surveillance (142 KB)
Guidance - Content of Field Safety Notice (58 KB)
Review of Requirements on Post-market Surveillance (187 KB)
Where to Send Adverse Event Reports (204 KB)
PMS Harmonization Chart (51 KB)
Reporting of Use Errors with Medical Devices by their Manufacturer (622 KB)
GHTF Study Group 3 - Quality Systems Guidance on Quality Systems for the Design and Manufacture of Medical Devices (132 KB)
Design Control Guidance for Medical Devices Manufacturers (125 KB)
GHTF Study Group 4 - Auditing Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements (159 KB)
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy (193 KB)
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports (138 KB)
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditing (157 KB)
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of Manufacturer Control of Suppliers (96 KB)
Training Requirements for Auditors (41 KB)
GHTF Study Group 5 - Clinical Safety/Performance Clinical Evidence for IVD Medical Devices - Key Definitions and Concepts (311 KB)
Clinical Evidence for IVD Medical Devices - Scientific Validity Determination and Performance Evaluation (746 KB)
Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices (419 KB)
Reportable Events During Pre-Market Clinical Investigations (196 KB)
Post-Market Clinical Follow-Up Studies (81 KB)
Clinical Investigations (85 KB)
Clinical Evaluation (604 KB)
Clinical Evidence - Key Definitions and Concepts (595 KB)
2.1 Scope, field of application, definition MEDDEV 2.1/1 (19 KB) Definitions of "medical devices", "accessory" and "manufacturer"
2.2 Essential requirements MEDDEV 2.2/1 rev.1 (16 KB) EMC requirements
MEDDEV 2.2/3 rev.3 (17 KB) "Use by" - date
2.5 Conformity assessment procedure General rules
Evaluation of medical devices incorporating products of animal origin. (See MEDDEV 2.11/1 rev.2 (82 KB))
2.7 Clinical investigation, clinical evaluation MEDDEV 2.7/1 rev.3 (378 KB) Clinical evaluation: Guide for manufacturers and notified bodies
Appendix 1: Cinical evaluation on coronary stents (101 KB)
2.10 Notified bodies MEDDEV 2.10/2 rev.1 (105 KB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices
2.11 Products using materials of biological origin MEDDEV 2.11/1 rev.2 (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 1 (42 KB)
2.12 Market surveillance MEDDEV 2.12/1 rev.8 (745 KB) Medical Devices Vigilance System
2.13 Transitional period MEDDEV 2.13 rev.1 (13 KB) Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)
2.14 IVD MEDDEV 2.14/1 rev.2 (75 KB) Borderline and Classification issues. A guide for manufacturers and notified bodies
2.15 Other guidances MEDDEV 2.15 rev.3 (33 KB) Committees/Working Groups contributing to the implementation of the Medical Device Directives
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 Staff (522 KB)
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)]
Draft Guidance for Industry and Food and Drug Administration Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
FDA Guidance - 2008 Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
FDA Guidances - 2005 Guidance for Industry and Food and Drug Administration Staff - Format for Traditional and Abbreviated 510(k)s
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing OFF-the-Shelf (OTS) Software
FDA Guidances - 2002 Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
FDA Guidance - 2001 Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
FDA Guidance - 2000 Guidance for Industry and for FDA Staff: Use of Standards in Substantial Equivalence Determinations
FDA Guidance - 1999 Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
Health Canada Guidance - 2013 Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices
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)
Health Canada Guidances - 2011 Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence
Guidance Document - Preparation of the Summary Technical Documentation (STED) - based Class III and Class IV Premarket Medical Device Licence Applications
Private Label Medical Devices: Questions and Answers
Health Canada Guidances - 2006 Notice: Updated Guidance on the Recognition and Use Of Standards under the Medical Device Regulations
Guidance Document: Recognition and Use of Standards under the Medical Device Regulations
Health Canada Guidances - 1999 Preparation of an Application for Investigational Testing - Medical Devices V.3
Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices (IVDD) V.3
Health Canada Guidances - 1998 Guidance for the Labelling of In Vitro Diagnostic Devices - DRAFT
Guidance for the risk based classification system - DRAFT
Guidance for the risk based classification system of in vitro diagnostic devices - DRAFT
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.