PRRC
PRRC – Person Responsible for Regulatory Compliance
According to Article 15 of both Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), all manufacturers and authorized representatives must designate one or more Persons Responsible for Regulatory Compliance (PRRC).
MDSS Consulting GmbH offers:
- experienced and qualified professionals to act as your external PRRC in accordance with MDR and IVDR, if you are seeking an external PRRC;
- additional support, such as targeted training, expert consulting, document reviews, or process-oriented assistance in daily operations, if your company has already appointed a PRRC;
You have the flexibility to decide whether MDSS Consulting GmbH assumes all regulatory responsibilities or provides targeted support in specific areas through a modular engagement.
The PRRC shall at least be responsible for ensuring that:
- The conformity of the devices is appropriately checked;
- The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
- The post-market surveillance obligations are complied with in accordance with Article 10(10) of MDR and Article 10(9) of IVDR.
- The reporting obligations referred to in Articles 87–91 of MDR and Articles 82–86 of IVDR are fulfilled.
- In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR and Section 4.1 of Annex XIV of the IVDR is issued.
Looking for PRRC support?
We work with you to find the right, individual, and tailor-made solution.
Request a free initial consultation* now.
Request a free initial consultation* now.