PRRC — Person Responsible for Regulatory Compliance
The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.
View in glossary →1 declared company affiliation
Public regulatory data · synced 2026-06-19
LUNDH Michael is a Person Responsible for Regulatory Compliance (PRRC) in the medical device industry. Currently affiliated with Doctrin AB. Explore their full professional profile and affiliations on MD Atlas.
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PRRC · a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; c) the post-market surveillance obligations are complied with in accordance with Article 10(10); e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Source: EUDAMED · non-removable