European Authorized Representative
Since If you are non-European manufacturer of medical devices and you wish to market your products in the EU market under your own name, you must designate a Regulatory Authorized Representative in order to meet the CE requirements. We are an official EU Authorized Representative for many medical device manufacturers worldwide and you can appoint us as your representative to manage the regulatory activities related to your product within the European Union.
To ensure compliance with the legislation in force, we propose the following services:
- Review and ensure your product compliance with the essential requirements set out in the applicable European Directive (i.e. EC 93/42, 90/385, 98/79).
- Register your device with the national Competent Authorities before being placed on the market.
- Maintain a current copy of your Technical File available for inspection by the European Competent Authorities and protect the confidentiality of your documentation.
- Provide you, with a European contact, details to be placed on your device labels, packaging and Instructions for Use, thus acting on your behalf as the main interlocutor for all European Competent Authorities.
- Support you to implement the necessary adaptations to your packaging, labeling and IFU to comply with national requirements (i.e. Translation).
- Perform the audits of your subcontractors located within the EU (Suppliers, distributors, etc.).
- Ensure vigilance, manage and coordinate any Incident resolution or Field Safety Corrective Action with the Competent Authorities, in cooperation with you and your distributors.
- Notify EU Authorities of all major incidents pertaining to products when necessary.
- Follow-up all EU regulations for each of the twenty seven EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.
By providing a unique expertise on medical devices, implantable medical devices and in-vitro diagnosis medical devices, our team of experts will assist you in introducing and maintaining your product(s) within the EU Market thus ensuring full compliance to the wide and complex regulatory requirements of the European Union.
Contact us today and let us help you meet your requirements