European Authorized Representative for Medical Devices, IVD, Regulatory Affairs

All non-European based Medical Device manufacturers require a European Authorized Representative in accordance Medical Device Directive 93/42/EEC and IVD Directive 98/79/EC. "Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorized representative". Click here for details

European Authorized Representative for Machinery in accordance with directive 2006/42/EC
All non-European Machinery manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturers technical 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. Click here for details

European Authorized Representative for Personal Protective Equipment in accordance with directive 89/686/EEC
All non-European Personal Protective Equipment (PPE) manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturers technical 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. Click here for details