About MME

Management declaration
Management declaration
« The ‘Authorized Representative’ is defined as any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the MDR & IVDR Regulations ».
MediMark® Europe was the first European Company of Regulatory Affairs which has set up, in 1995, (…)

MEDIMARK® EUROPE has been created early 1995 by René Clement in order to fulfil the need for non- European Manufacturers of Medical Devices to designate an official European Authorized Representative such as requested by the MD Directive and reinforced by the IVD Directive.
The focus on this activity has allowed MediMark® Europe with the help of Competent Authorities, to build tools and procedures which are recognized as the gold standard for product notification, incident reporting and (…)

Authorized Representative Responsibilities
Why MediMark Europe should be your choice?
Historic, references, key people
MediMark Quality Policy - Management Declaration

Definition and Main Responsibilities
« Authorized Representative means any natural or legal person established in the Community who, explicitly designated by the Manufacturer, acts and may be addressed by Authorities and Bodies in the Community instead of the Manufacturer with regard to the latter’s obligations under this directive ».
Under the Article 11 of the Regulations (EU) 2017-745 & 2017-746, the authorised representative shall perform at least the following tasks in (…)

Because we are certified to ISO 9001:2015 specifically for our activity of European Authorized Representative. Notification of your files to the European Data Bank (MD and IVD) through the French Competent Authority), Incident analysis, Reporting, Recall, Technical file review and maintenance, etc, are under quality system. Our customers may include controlled copies of our procedures directly in their own quality system. Because we are the first European Company of Regulatory Affairs (…)