European authorized representative for Medical Devices (EU MDR 2017/745) and In-Vitro Diagnostic Devices (EU IVDR 2017/746).
The newest medical device and in-vitro diagnostic device regulations (MDR/IVDR) require that manufacturers not established in an EU Member State appoint an authorized representative. A representative links your company and regulatory authorities and assists you with product registration, vigilance, and adverse event reporting.
Enable the legal marketing of products.
Ensure compliance with the registration rules.
Ensure that the declaration of conformity and technical documentation have been drafted in accordance with the law.
Communication with authorities.
“As EC Authorized Representative, Hemex Germany Gmbh will act as a legal interface between you, as a device manufacturer, and the EU. Our team will help you get your CE-marked products on the EU market.”
Services
- Review and ensure compliance with the general safety and performance requirements (GSPR)
- Acting on your behalf as the main contact for all European Competent Authorities
- Support and implement the necessary adaptations to packaging, labelling, and IFU to comply with national requirements
- Registration of the device with the national Competent Authorities before being placed on the market
- Audit of subcontractors located within the EU (Suppliers, distributors, etc.)
- Ensure the communication for vigilance, coordinate any incident resolution and/or Field Safety Corrective Action with the Competent Authorities
1/7
Define the products for
EU Market.
.
2/7
class and number of
products .
3/7
Existing
documents.
4/7
Extend
documentation.
5/7
Set up processes, implement measures.
6/7
Set up a collaboration
agreement.
7/7
Register as an authorized
representative agreement.
Ready?
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