Non-European manufacturer of medical devices willing to market medical devices or IVD in the EU market under their own name must designate a Regulatory Authorized Representative in order to meet the CE requirements.
We propose this service to many medical device manufacturers worldwide. In that perspective, we also often 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) or upcoming 2017/745 MDR and 2017/746 IVDR Regulations
- Register your device with the national Competent Authorities before being placed on the market.
- Maintain a current copy of your Technical Documentation 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.
We also help you building strategies related to the current BREXIT.