Article 15 of both the Medical Device Regulation 2017/745 (MDR) and In-vitro Diagnostic Regulation 2017/746 (IVDR) describe the new obligation that manufacturers must have at least one Person Responsible for Regulatory Compliance (PRRC) available within their organisation.
Manufacturers must demonstrate that the PRRC have the requirements detailed in the article. Micro and small enterprises will not be required to have a PRRC within their organisation, however they must have such a person permanently and continuously at their disposal.
The definition of micro and small enterprises is given below, in accordance with Commission Recommendation 2003/361/EC:
The definition of micro and small enterprises is given below, in accordance with Commission Recommendation 2003/361/EC:
- Employees < 10
- Annual Turnover / Annual Balance Sheet Total < EUR 2 million
- Employees < 50
- Annual Turnover / Annual Balance Sheet Total < EUR 10 million.
From the list of responsibilities covered under Article 15, it is clear that the role requires an excellent level of regulatory knowledge and experience, which is why Advena is your perfect choice to undertake this role for you. We can offer clients a cost-effective service for ensuring the obligations are met.
