For non-EU manufacturers looking to sell medical devices (MD) and in vitro diagnostic devices (IVD) in the European Union (EU) and European Economic Area (EEA)
Appointing an EU Authorised Representative (E.A.R) is a legal requirement under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
At EUmAccess GmbH, we act as your trusted E.A.R, ensuring your products comply with all necessary regulations, facilitating smooth market entry, and representing your company to the relevant EU Competent Authorities.
Our Responsibilities as Your EU Authorised Representative
Regulatory Compliance Support
- Ensuring your products meet MDR/IVDR requirements.
- Assisting with CE marking and regulatory documentation.
Communication with EU Authorities
- Acting as the official liaison between your company and EU Competent Authorities for all regulatory matters.
- Supporting you in responding to inquiries or inspections.
Technical Documentation Review & Storage
- Reviewing and maintaining a copy of your Technical Documentation, Declarations of Conformity, and post-market surveillance reports.
- Ensuring compliance with EUDAMED registration requirements.
Incident & Vigilance Reporting
- Managing post-market surveillance obligations.
- Reporting serious incidents and safety issues to Competent Authorities as required by law.
Product Labeling & Compliance Checks
- Ensuring your device labels comply with EU regulatory requirements, including displaying our name and address as your E.A.R.
Why Choose EUmAccess GmbH as Your E.A.R?
Expert Regulatory Knowledge
Our experienced professionals ensure full compliance with the latest MDR & IVDR requirements.
Fast & Efficient Service
We provide responsive, tailored solutions to get your products to market quickly and efficiently.
Secure & Confidential
We protect your sensitive technical files and regulatory information with strict confidentiality.
Continuous Compliance Support
We keep you updated on evolving EU regulations, helping you stay compliant.
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.