The EU Medical Device Regulation (MDR) requires manufacturers to have available at least one person, within their organization, responsible for Regulatory Compliance. That person is known as Person Responsible for Regulatory Compliance or PRRC (we love acronyms!).
For a Micro and/or small enterprise, the PPRC does not need to be within the manufacturer’s organization but must be permanently and continuously at their disposal. Does your company have a qualified PRRC? One with the requisite expertise? This person (or persons) is responsible for assuring device conformity and technical documentation (among other tasks). Choose this person carefully. A bad choice could severely impact your ability to sell products into the EU market.
Any questions? We, here at Conformity Tech, are here to help!