European Authorized Representative

European Authorized Representative Services for Medical Devices and In-vitro Diagnostics

The regulations of the EU Medical Device Directive 93/42/EEC (MDD), In-vitro-Diagnostic Directive 98/79/EC (IVDD), and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) require a manufacturer located outside the European Economic Area (EEA) to designate a European Authorized Representative as a liaison to the European Competent Authorities.

Since 1995 MT Promedt Consulting provides qualified and professional Authorized Representative Services in all European countries. Our services will support your company to comply with the European regulations.

MT Promedt Consulting European Authorized Service include:

Legal Interface

	Product Notification to European Competent Authorities
	Identification of requirements for and performance of national notifications
	Identification of language requirements
	Class I self certification package
	Notification of Clinical Investigations
	Interaction with EU Competent Authorities
	Holding of Technical Product Files
	Authorized European Address

Product Safety Related Activities

	Implementation of a Medical Device Vigilance System
	Medical Device Complaint and Incident Reporting System
	Liaison between manufacturer, distributors, and EU authorities

Additional Services

	Documentation Review
	Advice on Labelling materials
	Translation services

MT Promedt Consulting offers European Authorized Representative services with offices in Germany and the US.

Our services will guarantee you full compliance with all EU regulations during the pre- and post-marketing phase in Europe. By appointing us as your independent representative, you will keep the highest possible flexibility in your distribution network. Our services will facilitate the fast entrance of your products into the European market.

MT Promedt Consulting - Your Gateway to the European Medical Device and IVD Market

MT Promedt Consulting is a founding member of the European Association of Authorized Representatives

Feel free to contact us.