The service of the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the MDR regulation is a consultancy and support service for the manufacturer or authorized representative of medical devices to ensure compliance with current regulations.
The Person Responsible for Regulatory Compliance (PRRC) must possess the necessary expertise in the field of medical devices to ensure compliance with all obligations set out in the MDR regulation, including:
- Assessing product compliance with essential requirements.
- Preparing technical documentation and the CE Declaration of Conformity.
- Managing post-market surveillance processes and market withdrawals.
- Representing the manufacturer or authorized representative to competent authorities.
The PRRC for SMEs can be an internal employee of the company or an external consultant. In both cases, it is important that the PRRC is independent and can perform their work impartially. The service offered by AP Engineering includes taking on these responsibilities by assuming the role of PRRC. The benefits of the PRRC service are numerous, including:
- Increased likelihood of product compliance with current regulations.
- Reduced risk of sanctions from competent authorities.
- Improved efficiency of compliance management processes.
- Support for the manufacturer or authorized representative in risk assessment associated with the product.
- Assistance for the manufacturer or authorized representative in defining applicable essential requirements for the product.
- Support for the manufacturer or authorized representative in preparing technical documentation.
- Assistance for the manufacturer or authorized representative in managing post-market surveillance processes.
- Representing the manufacturer or authorized representative to competent authorities.
In conclusion, the PRRC service is an important service that can help manufacturers and authorized representatives of medical devices ensure compliance with current regulations and reduce the risk of sanctions. If you have not yet identified the PRRC or lack the expertise to fulfill the role of PRRC, contact us, and we will help you meet the obligations set out by current legislation.