EU Authorized Representative

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EU Authorized Representative

EU Authorized Representative

From May 2021, Non-EU manufacturers selling medical devices to consumers in the European Union must appoint a European Authorized Representative. Medical devices Imported into the EU must also have the address and contact details of the European Authorized Representative. We are a regulatory consultant and authorized EC Representative firm for the successful marketing of medical devices in Europe.

EC Representative Appointment process as per MDR and IVDR

The following are the important steps –

Step 1	Identify the EC Representative (E.A.R / EU Rep / EC Rep)
Step 2	Submit signed DOC, and Test Reports Or Notified Body issued valid CE Certificate.
Step 3	Authorize the annual EAR fees.
Step 4	Sign a legally binding document listing the duties and responsibilities of both sides.
Step 5	EAR completes EU Registration
Step 6	SRN Number / EUDAMED Registration (applicable from May 2021
Step 7	Start Marketing in Europe.

EC Representative Responsibilities

We provide registered addresses and contact information to display on the primary information panel.
MDR or IVDR Technical Documentation a gap analysis.
MDR or IVDR Technical guidance
Maintains a copy of technical documentation.
Device Label review.
EUDAMED support.
Incident Reporting.
Update customers in a case of significant regulatory change (Optional)

European Free Sale Certificate (FSC)

Government medical device regulatory bodies in Asia, Latin America, and the Middle East demand that overseas manufacturers give a free sale certificate confirming that their products are allowed for sale in Europe. The EC Representative arranges FSC from the German authorities, which is recognized by the regulatory authorities in the above-indicated nations indicated.

Our Fees starts from 4500 Euros (One-time)

Request for proposal

Our Fees

Annual Fees in Euros ( Euros will be converted into INR for Indian Customers)
Class I	Class Is /m/r	Class IIa	Class IIb	Class III
1000	1050	1150	1350	1550
EUDAMED Registration Initial Set up fees				800
EUDAMED Registration for a set of 2 devices with maximum 5 variants				2500

Annual Fees in Euros ( Euros will be converted into INR for Indian Customers)
A	B	C	D
1000	1150	1350	1650
EUDAMED Registration Initial Set up fees				800
EUDAMED Registration for a set of 2 devices with maximum 5 variants				2000

UDI DI Number Support

UDI DI number applies to all devices, except custom-made and investigational devices. This is mandatory from 26 May 2021 for medical devices and 26 May 2022 for In-Vitro diagnostic devices.

Note: The framework is not ready today and is expected to start in the coming months. We will update the information accordingly on our website.

Our Services

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We will respond to you within one working day.