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Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [ 7 ] European ‘Blue Guide" [ 8 ] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks.
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
The International Organization for Standardization and the International Electrotechnical Commission, international standard-setting bodies composed of representatives from various national standards organizations, define the different testing, inspection and certification services in the international standard ISO 17000 series which includes ISO/IEC 17000:2020 conformity assessment ...
The International Accreditation Forum, Inc. (IAF) is the worldwide association of conformity assessment accreditation bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel, processes, validation and verification and other similar programs of conformity assessment.
Here's what effective federal rules around autonomous vehicles could look like, according to a former DOT inspector general
U.S. shipments of weapons into Ukraine were briefly paused in recent days before resuming over the weekend as the Trump administration debated its policy towards Kyiv, according to four people ...
ISO/IEC 17024: Conformity assessment - General requirements for bodies operating certification of persons is an ISO/IEC standard which specifies criteria for the operation of a certification body for persons. The standard includes requirements for the development and maintenance of the certification scheme for persons upon which the ...