Horizon Phoenix, your North American-based CE Mark expert, provides Manufacturers with Authorized European Representation.
European Directives require that manufacturers based outside of the EU appoint a representative based in the EU. Horizon Phoenix, with offices located in Ireland, provides cost effective representation services for medical device, biotechnology and personal protective equipment manufacturers.
Horizon Phoenix will not only fulfil your representation obligations but also:
- Liaise and coordinate negotiations on your behalf with the Competent Authority in cases of disputes with your notified body regarding quality system registration, product certification or testing, medical device risk classification, CE marking, product labelling, manufacturers instructions for use and/or other technical documentation.
- Archive documentation as required by European Directives, Competent Authorities or national legislation.
- Register manufacturers of Class 1 products, custom made devices, systems or procedure packs and those involved with the sterilization of medical devices.
- Liaise with all European member states and relevant Competent Authorities for vigilance, post market surveillance and other product related issues.
- Give you a competitive edge by monitoring the European regulatory environment to keep you apprised of new or revised requirements and options which may be available for compliance.
Why Horizon Phoenix?
- Absolute confidentiality - we are not importers nor distributors; your product related information is in safe hands.
- Each Horizon Phoenix partner is fully accredited within their field of expertise, e.g., Medical Device Consultant; Medical Device Lead Auditor, etc. Some even hold academic appointments at major Universities.