CEN/TC 205/WG 5 - Good manufacturing practices
To be responsible to TC 205 for the preparation of standards for good manufacturing practices for the manufacture of non-active medical devices.
Good manufacturing practices
To be responsible to TC 205 for the preparation of standards for good manufacturing practices for the manufacture of non-active medical devices.
General Information
This European Standard provides guidance on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. It does not add to, or otherwise change, the requirements of those standards and is not intended to be used for the assessment of a manufacturer's quality system. This European Standard provides examples of how to meet the requirements, recognising that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements; and draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for non-active medical devices. Annex A to this European Standard provides guidance on the elements of quality systems which are relevant to the manufacture of medical devices which are to be supplied either sterile or at a defined level of microbiological or particulate cleanliness. The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the specific requirements in EN 46001 and EN 46002.
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Frequently Asked Questions
CEN/TC 205/WG 5 is a Working Group within the European Committee for Standardization (CEN). It is named "Good manufacturing practices" and is responsible for: To be responsible to TC 205 for the preparation of standards for good manufacturing practices for the manufacture of non-active medical devices. This committee has published 1 standards.
CEN/TC 205/WG 5 develops CEN standards. The scope of work includes: To be responsible to TC 205 for the preparation of standards for good manufacturing practices for the manufacture of non-active medical devices. Currently, there are 1 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.