European (EU) Authorized Representative

According to European law for medical devices, companies that do not have a physical location in the Europe must appoint a European Authorized Representative who is located within Europe. It is required for 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. After appointing European Representative he/she or there company will effectively ensure your company’s compliance with the European Regulatory reporting requirements as per the tasks required in the applicable directives.

The Authorized Representative performs certain duties under the European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. EU/EC Authorized/Authorized Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives.

The Aspects of an Authorized Representative

  1. The Authorized Representative must be included on the product labeling (and/or) instructions for use (etc.).
  2. The Authorized Representative is responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs.
  3. The Authorized Representative is obliged to submit Medical Device Reports (MDRs) on behalf of the manufacturer.
  4. The Authorized Representative must be appointed in writing (MOU) . All duties and responsibilities should be clearly defined and assigned.
  5. The Authorized Representative must at all times be available to interact between the manufacturer, the European Authorities and the notified body.

Readers can Contact us for finding an appropriate and economic Authorized Representative. You can also purchase MOU (Memorandum of Understanding) template for EU Representative from our download section.

Notified Bodies for Medical Devices

The Governments of the European member states designated some organizations known as Notified Bodies who are being found competent to make independent judgments about whether or not a medical device (product) complies with the essential requirements laid down by each CE marking directive. Up-to-date contact details for all Notified Bodies, as well as details of their scope of notification, can be found in European Commission's NANDO database.

The Notified Bodies are restricted to provide advice and assistance to clients whose products are being tested and certified by them. As consultants we believe that we can offer a better and cheaper service to clients without any restrictions. We normally takes turnkey projects , based on the repeated need of industry - “single point contact” Where we place business with Notified Bodies on behalf of clients, it is our practice to pass the Notified Body fees on at cost to the client with minimum deviation on taxes and service fee.

We take up the responsibility of certifying your device in the allocated time!!! What we do?

  1. Find the Notified Body for client based on budget and internal readiness.
  2. Prepare technical file on behalf of client and submit to Notified Body.
  3. Coordinate with Notified Body

No matter where you are? Which country? Which city? What device?

Leave it to AVS Certification Services!!!

Contact us for arranging lowest quote from any Notified Bodies around the World. Know approximate fee, please send an e-mail to us.

The Authorised Representative shall provide the relevant authorities with such information as is necessary for them to assure themselves of the safety or otherwise, of the product. The authorised representative is not responsible for the product or its impact within the European Union but is responsible for maintaining data relevant to the manufacture and the design of the product.

The appointment of an Authorised Representative secures for a manufacture a presence within the Union specifically for quality assurance purposes. A contract between the manufacturer and the authorised representative is necessary. The contract is in two parts (i) initial registration and annual maintenance of status and (ii) Contingency support; this is invoked in the event that relevant authorities require examination of the Authorised Representative's records and managerial or technical support.

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