ETHOS – EC Authorised Representatives Accreditation
We are excited to announce that our company has officially received accreditation to act as EC Authorised Representatives through our Ireland-based entity. This milestone underscores our commitment to regulatory compliance and our dedication to serving the European market.
Understanding EC Authorised Representatives
An EC Authorised Representative (EC-AR) is a legal entity established within the European Union that acts on behalf of non-EU manufacturers in relation to specific tasks required under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This role is essential for ensuring that non-EU manufactured medical devices meet EU regulatory standards and can be marketed within the EU.
Key Responsibilities of an EC Authorised Representative
- Regulatory Compliance: Ensuring that non-EU manufacturers comply with the EU MDR and IVDR. This includes verifying that the manufacturer’s products meet all applicable safety and performance requirements.
- Product Representation: Acting as the primary contact point for EU Competent Authorities regarding the manufacturer’s products. This involves maintaining communication with regulatory bodies and facilitating any necessary inspections or audits.
- Technical Documentation: Holding and maintaining the Technical Documentation and the Declaration of Conformity for the manufacturer’s products. This documentation must be readily available for review by EU authorities upon request.
- Incident and Vigilance Reporting: Ensuring that serious incidents and field safety corrective actions (FSCA) are reported to the appropriate EU authorities. This includes managing the communication and documentation of adverse events associated with the manufacturer’s products.
Our Commitment
Achieving EC Authorised Representative status demonstrates our ongoing commitment to upholding the highest standards of regulatory compliance. This accreditation enables us to better serve our clients by ensuring their products meet EU regulatory requirements, facilitating smoother market entry and sustained compliance.
We look forward to leveraging this accreditation to enhance our service offerings and support our clients in navigating the complex regulatory landscape of the European market
