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If you want to know more about regulatory issues of Medical
Devices, click here.
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All Non-European manufacturers of medical equipment who wish to market their products in the EU market under their own name must designate a Regulatory Authorized Representative in order to meet CE requirements. |
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What are your responsibilities related to your Authorized Representative and how we can help you? |
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Once
you have appointed your Authorized Representative and
completed your CE requirements, you will be requested to:
- Report
any case that meets the reporting requirements to the Authorities.
The criteria and procedures of such reporting will be provided by
us. In accordance with the Directives, the Authorized Representative
reports to the Authorities.
- Update
your labelling (product / user manual / packaging) with the details
of your Authorized Representative offices (Medes
Ltd. UK). Labelling instructions and guidelines will be provided by
us.
- For
class I devices in Europe, you will also need to provide us with a
copy of the product Technical Files. In accordance with the Directives
the Authorized Representative keeps this information
available for the Authorities.
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