Senior USA: FDA Designated Agent – On Line Registration

Medes Inc – USA: FDA Designated Agent – Arazy Group

Medes Limited – EU: CE Authorized Representative – Arazy Group

If you want to know more about regulatory issues of Medical Devices, click here.

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.

Why choose Medes Limited your Regulatory Authorized Representative?

One of the most important choices you, as a manufacturer of medical devices or laboratory equipment, will need to make is the appointment of a proper Regulatory Authorized Representative.

Medes Limited UK located in Radlett, Hertfordshire, is such qualified and recognized Authorized Representative. We have been serving hundreds of companies worldwide since 1996.

From the very moment you appoint us as your Authorized Representative we shall handle registration and listing of devices and manufacturers, as well as corresponding, complaint handling and reporting regulatory issues to European Authorities in EU.

Medes offices are part of the Arazy Group, an international leading organization in the field of Medical Device Consultation. The group has been providing hundreds of companies worldwide with complete range of services, ranging from product regulatory and manufacturer compliance to clinical studies and marketing research.

What if you wish to discontinue?
This is even simpler! Anytime you wish to discontinue our Authorized Representative services, simply e-mail or fax us. Assuming there are no outstanding payments, our agreement will be terminated within 30 days. All relevant authorities and bodies will be notified by us.

What are the Responsibilities of the European Authorized Representative

The responsibilities of the Authorized Representative are:

Assisting European Authorities in communications with foreign establishments
Assisting European Authorities in scheduling inspections of the foreign establishment
Handel reports concerning vigilante activities or recall of products
On top of these Authorized Representative services we can also provide consulting services for writing or reviewing as well as maintaining Technical Files

References for the need to appoint a Regulatory Authorized Representative

The European Medical Device Directive 93/42 EEC Article 14
The European IVDD Directive 98/79EC Article 10.

What are your responsibilities related to your Authorized Representative and how we can help you?

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.

Services that we offer for CE marking

Preparation of regulatory strategy for the CE marking of any new product you wish to develop, manufacture and eventually export.
Manufacturer registration and product listing (CE marking) of all your medical products with the Regulatory Authorities.
Adverse Incident and Recall Reporting of products with CE marking to the Regulatory Authorities.
Handling of customer complaints received through the regulatory authorities regarding products with CE marking.
Consultation services regarding CE marking of any medical device or laboratory equipment: Regulatory / QA / Product Compliance.