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Authorized Representative |
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Who needs an Authorized Representative? |
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All manufacturers who do not have a registered place of business in a Member State of the EU or EFTA, nor in Switzerland, and who are manufacturing
- In vitro diagnostic medical devices (all classes)
- Medical devices (Class I)
- Personal protective equipment (all categories)
are obliged to appoint an authorized representative.
All Class II/III MD manufacturers may appoint an authorized representative, but are not obliged to (current regulation – 93/42/EEC)
IMPORTANT ! According to the new draft revision of the MD Directive, Class II/III MD manufacturers will be obliged to appoint an authorized representative. |
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The role and responsibilities of the Authorized Representative are described in several places of the Directives : |
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For example, in the IVD Directive:
- Acts and may be addressed by authorities and bodies in the European Union instead of the manufacturer with regard to the latter's obligations under the Directive (Art. 1. 2 (g))
- Notifies the Competent Authorities of the address of the manufacturer (Art. 10)
- Notifies the Competent Authorities of the manufacturer's products (Art. 10)
- Notifies the Competent Authorities of changes to the products (Art. 10)
- Notifies the Competent Authorities of performance characteristics
(Annex II products and devices for self-testing only) (Art. 10)
- Draws up the statement concerning devices for performance
evaluation (Annex VIII)
- May be contacted by the Commission in the context of the Safeguard Clause (Art. 8)
- May initiate Conformity Assessment Procedures (Art.9.6)
Must make technical documentation available to authorities on their request
(Art. 9.7)
- Is informed by Competent Authority about incidents (Art. 11)
- May be the interface between Notified Body and manufacturer (Art. 15)
In the case of a wrongly affixed CE-mark, the Authorized Representative must bring the infringement to an end (Art. 17) |
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Why appoint Qarad as your Authorized Representative? |
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Qarad is an independent organization. This keeps your commercial and regulatory interests in Europe separated. It allows you to give all your European distributors and O.E.M. customers independent regulatory support. It is not recommended to appoint a distributor as your authorized representative .
A good Authorized Representative is more than a mailbox. He guides you through the regulations, assists you in the case of regulatory action against your company and communicates to the competent authorities. This requires a unique mix of regulatory, technical-scientific and communication skills .
Qarad’s team has the adequate experience and qualities.
Qarad is a member of the European Association of Authorized Representatives and subscribes to its Code of Conduct. |
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Qarad as your Authorized Representative: practical |
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Contract between your company and Qarad, outlining mutual tasks and responsibilities.
Annual fee, covering authorized representative services. Costs will be proportionate to services delivered.
Contact us for a price quotation. |
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