Medical Devices and IVD
Medical device manufacturers require a European Authorized Representative in accordance with Medical Device Regulation 2017/745 and IVD Regulation 2017/746 .
for CE marked Medical Devices, IVDD, Machinery, Pressure Equipment, ATEX and Personal Protective Equipment.
Medical device manufacturers require a European Authorized Representative in accordance with Medical Device Regulation 2017/745 and IVD Regulation 2017/746 .
Effective 29 December 2009 all non-European based machinery manufacturers are required to indentify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturers tecnical file or have quick access to it. The Authorized Representative must have a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
Machinery Directive 2006/42/EC, Pressure Equipment Directive 2014/68/EU, ATEX Directive 2014/34/EU.
PPE Directive 89/686/EEC.