Direct Links to important GMP Medical Device Guidelines

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 4: Multiple Site Auditing

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers with multiple sites. This document should be read in conjunction with the Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers -- Part 2: Regulatory Auditing Strategy (GHTF/SG4/N30).

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers

This document gives guidance for the auditing of a manufacturer’s purchasing controls, including the audit of the suppliers when suppliers should be audited and what a supplier audit should cover, adding to the guidance given in GHTF/SG4/N28 and GHTF/SG4/N30.

Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers Supplement No. 3: Training Requirements for Auditors:2000

The document describes in more detail training elements required to:i prepare an individual to be an auditor; ii qualify auditors to conduct regulatory audits of medical device manufacturers’ quality systems; and iii maintain their qualifications.

COMMISSION DIRECTIVE 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin

General protection of public health against the risks of transmitting the animal spongiform encephalopathies via medical devices

DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices

This Directive aims at including in the scope of Directive 93/42/EEC (2) only medical devices which incorporate,as an integral part, substances derived from human blood or human plasma.

DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma

In addition to being directed at medical devices for in vitro diagnosis, the Commission proposal sought to amend Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (4) in order to extend its scope to medical devices manufactured by using nonviable tissues or substances of human origin derived from those tissues. This amendment was not included in Directive 98/79/EC (5) when it was adopted.

Unique Device Identification (UDI) System for Medical Devices

A UDI unambiguously identifies a manufacturer’s specific medical device. A standardized UDI applied to the device or its label, documented in the UDI Database, and used consistently throughout distribution and use should facilitate a number of patient safety benefits, including: • traceability of devices, • the identification of devices in adverse events reports and other postmarket safety surveillance activities, • recalls and other field safety correction, and • reducing medical errors.

FDA Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers

This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices,and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72).

Media Statement Successful Launch to the IMDRF

Good progress and a commitment to advancing regulatory convergence and public health marked the inaugural meeting of the International Medical Device Regulators Forum (IMDRF), held in Singapore from 28 February to 1 March 2012. Regulators from Australia, Brazil, Canada, Europe, Japan, and the United States of America were joined by regulatory observers from China and the Russian Federation and by the World Health Organization for the purpose of putting the new Forum into operation and planning the transition of several key items from the Global Harmonization Task Force.

IMDRF Terms of Reference

The mission of the International Medical Device Regulators Forum (IMDRF) is to strategically accelerate international medical device regulatory convergence1 to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety.

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