PRRC
Do you wish to act as a Swiss Authorised Representative but lack in-house expertise for the PRRC function? Medalps provides dedicated PRRC services to help you meet the Swiss requirements and access the market with confidence.
MedDO: Swiss Transposition of the EU MDR
Under the Swiss Medical Device Ordinance (MedDO / ODim), which transposes the main obligations of the EU MDR (2017/745), Swiss Authorised Representatives (CH-REP) must appoint a Person Responsible for Regulatory Compliance (PRRC). This role ensures that documentation, declarations of conformity, post-market surveillance, and vigilance obligations are properly managed.
Your trusted PRRC partner in Switzerland
At Medalps, we take on this responsibility on your behalf. Our services include acting as your external PRRC for Switzerland and managing Swissdamed registrations, ensuring full alignment with the MedDO and ongoing compliance for your devices.
Peace of mind for manufacturers and CH-REP
By outsourcing your PRRC function to Medalps, you gain regulatory certainty, expert oversight, and the assurance that your compliance is continuously safeguarded in the Swiss market.