EUmAccess GmbH – EU Authorised Representative Certificate of Confirmation (E.A.R COC) for Class I Devices
What is the E.A.R Certificate of Confirmation (COC)?
For Class I Medical Devices (self-certified under MDR 2017/745), non-EU manufacturers must appoint an EU Authorised Representative (E.A.R) to ensure regulatory compliance. Once appointed, EUmAccess GmbH issues a Certificate of Confirmation (COC), officially verifying that we act as your E.A.R.
This E.A.R COC is a key document used for regulatory compliance, customs clearance, and market placement within the European Economic Area (EEA).
Purpose of the E.A.R COC
The E.A.R Certificate of Confirmation serves to:
Confirm EU Representation
Certifies that EUmAccess GmbH is your legally appointed EU Authorised Representative in accordance with MDR 2017/745.
Facilitate Customs Clearance
Helps streamline import and market access processes for non-EU manufacturers.
Support Regulatory Compliance
Demonstrates compliance with EU MDR requirements, including post-market surveillance and vigilance obligations.
Assist in EUDAMED Registration
Required for registering Class I devices in the EUDAMED database
Who Needs an E.A.R COC?
Non-EU manufacturers of self-certified Class I medical devices under MDR 2017/745 must appoint an EU Authorised Representative (E.A.R.) and obtain an E.A.R Certificate of Confirmation (COC) before marketing their products in the EU/EEA.
Note:
- Class I (Sterile) and Class I (Measuring Function) devices require Notified Body involvement and additional documentation.
- EUmAccess GmbH does not issue COCs for higher-risk classes (Class IIa, IIb, III) requiring Notified Body certification.
How to Obtain Your E.A.R COC from EUmAccess GmbH?
Sign an EU Authorised Representative Agreement
Appoint EUmAccess GmbH as your E.A.R.
Submit Required Documents
Provide the Declaration of Conformity (DoC), Technical File Summary, and Labeling Information for verification.
Compliance Review
Our experts review your documentation for compliance with MDR 2017/745.
Issuance of E.A.R COC
Upon successful review, we issue your Certificate of Confirmation, allowing you to legally sell your Class I device in the EU.
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.