manufacturer

natural or legal person responsible for the design, manufacture, fabrication, assembly, packaging or labelling of a medical device, for assembling a system, or adapting a medical device before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on their behalf by a third party

Note 1

Provisions of national or regional regulations could apply to the definition of manufacturer.

Note 2

Manufacturer includes those who perform the functions of contract sterilization, installation, relabelling, remanufacturing, repacking or specification development, and initial distributors of foreign entities performing these functions.

Note 3

A harmonized definition of "manufacturer" is being developed by the GHTF.

Bron

ISO 14971:2007, definition 2.8

Norm

NEN-EN-ISO 18113-1:2011 en

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.36

manufacturer

Gerelateerde termen