Authorized Representatives For Medical Devices (MDD 93/42/EEC), In Vitro Diagnostics Devices (IVDD 98/79/EEC), Active Implantable Medical Devices (AIMD 90/385/EEC)

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Aspects of the Authorized Representative:

The appointment of an Authorized Representative for the Member States for the EEA is required in the European Medical Devices Directives (Medical Device Directive 93/42/EEC; Active Implantable Medical Devices 90/385/EEC; and, In Vitro Diagnostic Medical Device Directive 98/79/EEC).

An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing Methodize Inc., as your European Representative will effectively ensure your company’s compliance with the European Regulatory Reporting requirements.

We invite you to visit all the pages of our web site to learn about Methodize Inc. and how we can be of service to your company. We encourage you to make use of our vast stores of research materials, news, information and updates to Medical Device Directives and regulatory affairs authority web sites.

According to European law for medical devices, companies that do not have a physical location in the EU must appoint a European Authorized Representative who is located within Europe.

Methodize Inc. can provide your company with an official EU Authorized Representative that will act as your liaison with the national Competent Authorities. With offices in Galway, Ireland, Methodize Inc. has provided this service to hundreds of companies who desire to sell their medical device in Europe.

Email Methodize Inc. to receive a free proposal or for more information.

The Aspects of an Authorized Representative

The Legal Aspects

• The Authorized Representative must be included on the product labeling (and/or) instructions for use (etc.). From a legal standpoint, he becomes intrinsically tied to the manufacturer.
• The Authorized Representative is responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs.
• The Authorized Representative is obliged to submit Medical Device Reports (MDRs) on behalf of the manufacturer. Failure to meet deadlines, or any other inconsistencies, may have serious repercussions, both for the Representative and the manufacturer.
• The Authorized Representative must be appointed in writing, by contract; all duties and responsibilities ought to be clearly defined and assigned.
• The Authorized Representative ought to be reflected in the manufacturer's Quality Management system.
• The Authorized Representative may face liability claims resulting either from product malfunction or serious complaint.
• The Authorized Representative needs to be included in the manufacturer’s product liability insurance policy.
• The Authorized Representative must at all times be available to interact between the manufacturer, the European Authorities and the notified body.
• The Authorized Representative is an external part of the manufacturer's Quality System - possibly the most vulnerable element in the Quality Management system.

The Safety Aspects

• The Authorized Representative must meet all relevant deadlines. Failure to adhere to them carries penalties.
• The Authorized Representative requires qualified staff (i.e. Some Member States have regulations over and above those required by Directive, such as the Safety Officer for Germany who must have a University Degree and a minimum 2 years Medical Device experience).
• The Authorized Representative requires that the Authorized Representative is capable to make qualified pre-submission judgment (in the event of an incident) on behalf of the manufacturer.
• The Authorized Representative should be in a position to ensure that he provides qualified and trained (Regulatory Affairs) personnel to cover the responsibilities entailed.
The Authorized Representative ought to have sufficient individual Member State requirements (when applicable).