- Prepare and make submissions to Ethics Committees
- Prepare and make Notifications to Competent Authorities
- Assist the manufacturer in contracting indemnity insurance for clinical trial participants
- Advise on reporting requirements for SAEs and SADEs in the various Member States
- Dialogue with Competent Authorities
- Attend inspections by Competent Authorities at clinical investigation sites

Authorized Representative Services for CE marked Medical Devices

- Act as a central contact point for the Competent Authorities and the European Commission.
- Act on behalf of the client during conformity assessment procedures.
- Make applications to Notified Bodies for conformity assessment procedures.
- Advise on labelling issues and other national requirements for placing medical devices on the EU market
- Review technical documentation for compliance, maintain and update documentation as required by the manufacturer
- Perform product registrations in various Member States as required
- Assist in determining reporting requirements for incidents and prepare vigilance reports
- Represent the manufacturer in the case of a Competent Authority’s decision to refuse or restrict the placing on the market of a product or to require withdrawal of a product from the market.
- Keep available at the disposal of Competent Authorities and Notified Bodies, technical documentation, certifications and declarations of conformity.
- Submit to inspections of MedPass’ Authorized Representative activities by government authorities.