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Authorized Representative for Medical Device Directive 93/42/EEC and IVD Directive 98/79/EC
QNET offers Authorized Representative services for devices of all risk classes in Europe. This service includes:
- QNET B.V as the name you may print on your CE-marked devices and related printed materials i.e. labels, instructions for use, inserts, manuals, websites.
- Registering of your CE-marked devices with the appropriate Competent Authorities and holding your technical file available as required.
- Monitoring changes to the directives and regulations and contact you only when there are issues that deserve your attention.
- Interfacing on your behalf between Competent Authorities, Notified Bodies and your distributors or end-users.
- Performing an annual review of your technical file content with a reminder to update or change existing documentation.
- Protecting your documentation's confidentiality by contractually agreeing to show them to the Competent Authorities only.
- Co-Signing your Declaration of Conformity.
Click Here for an Authorized Representative proposal form
Frequently Asked Questions about the role of the European Authorized Representative.
Click Here for FAQs
Click Here for an Authorized Representative proposal form
Contact us for more info
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