European Authorized Representative Agreement For Medical Devices
Description
How to fill out European Authorized Representative Agreement For Medical Devices?
There's no longer a necessity to squander time hunting for legal documents to fulfill your local state obligations.
US Legal Forms has gathered all of them in one location and streamlined their accessibility.
Our platform offers over 85,000 templates for any business and personal legal matters categorized by state and area of application.
Utilize the search field above to browse for another template if the current one did not meet your needs.
- All forms are professionally crafted and confirmed for authenticity, so you can trust in acquiring an updated European Authorized Representative Agreement for Medical Devices.
- If you are acquainted with our platform and already possess an account, ensure your subscription is active before obtaining any templates.
- Log In to your account, select the document, and click Download.
- You can also revisit all saved documents whenever necessary by accessing the My documents tab in your profile.
- If you've never utilized our platform before, the process will require a few additional steps to complete.
- Here's how new users can acquire the European Authorized Representative Agreement for Medical Devices from our library.
- Examine the page content thoroughly to verify it contains the sample you need.
- To do so, make use of the form description and preview options if available.
Form popularity
FAQ
From 16 July 2021 you will need to appoint an authorised representative based in the EU, EEA or Northern Ireland if you sell certain goods without using an importer or fulfilment service provider, for example if you sell online and ship directly to the end user.
European Authorized RepresentativeProviding a registered address within the European Union.Keeping all technical documentation available for inspection by the European Authorities.Completing notifications to European Authorities.Completing any registrations to national databases.Taking care of any incident reporting.More items...
An EU representative is the point of contact for EU data subjects and data protection supervisory authorities. The representative acts on behalf of a controller or processor with regard to their obligations under the GDPR.
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product.
Do we have to put the name of the Authorized Representative on our labeling, packaging and IFUs? Yes. You must list the name and address of the Authorized Rep on the product label, outer packaging and/or Instructions for Use.