Eurotrade in association with Consultants Europe offers a unique package of services which
- Maintenance and
administration of Technical Files, which are obligatory in the CE
- Representation and registered
address in Europe.
- Deal with all judicial
procedures related to products.
- Inquiries from distributors,
agents, customers, inspection authorities in liaison with and on
behalf of the client.
- Technical and legal
assistance in liability claims.
European medical devices directives require the
appointment of an Authorized Representative. The label and/or the
instructions for use and/or the outer packaging of a device must contain
the name and address of the authorized Representative of the
manufacturer or exporter established within the European Economic Area.
Eurotrade as your Authorized Representative must:
- Represent the Manufacturer in case of withdrawal of
a medical device by a Member State(s).
- Represent the Manufacturer
before the national Competent Authorities in the European Economic
- Be available at all times to interact between the
manufacturer and the national Competent Authorities; Be informed by
the Competent Authorities of any incident(s).
- Be responsible for incident
reporting before Competent Authorities, in close liaison with the
Manufacturer and the distributors.
- Notify the Competent Authorities which
investigations are to be conducted with regard to the product.
- Keep at disposal the critical evaluation report of
all data for Competent Authorities.
Authorized Representation Services include:
- Verification of the classification of the medical
device(s), and carrying out of a CE end-control. This CE end-control
includes an investigation of the device and technical documentation
(technical file), labeling and packaging.
- Use of Consultants Europe's
name and registered address in Europe (label requirement); office,
phone, fax, mail handling, etc.
- Notification to the Competent Authorities of the CE
Declaration of Conformity, with description of the concerned device
and names and addresses of distributors established in the Community.
- Notification of the Competent
Authorities of any changes in the product.
- Administration of the
technical file; presentation of the file or parts of it to Competent
Authorities, when approved by client.
- Technical and legal representation, assistance, and
reporting in case of incidents reported by users, distributors, or
National Competent Authorities. Organisation and carrying out, with
the Manufacturer, the Incident Reporting.
- Carrying out of assessment
and determination of the severity of incidents.
- Representation before the European Commission and
national Competent Authorities, in case of recall or risk of product
or withdrawal from the market.
- "Product Information Desk" regarding all inquiries.
We welcome all inquiries and will be pleased to provide more detailed
Information on our Authorized Representation services and contractual