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MK

MAKOWSKI Karol

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.

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1 declared company affiliation

Source: EUDAMED

Public regulatory data · synced 2026-06-19

20%

MAKOWSKI Karol is a Person Responsible for Regulatory Compliance (PRRC) in the medical device industry. Currently affiliated with WARMIE. Explore their full professional profile and affiliations on MD Atlas.

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  • WARMIE

    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 →
    MDR: a) odpowiednie sprawdzanie zgodności wyrobów zgodnie z systemem zarządzania jakością, w którym te wyroby są wytwarzane, przed zwolnieniem wyrobu; b) sporządzanie i bieżąca aktualizacja dokumentacji technicznej i deklaracji zgodności UE; c) przestrzeganie obowiązków w zakresie nadzoru po wprowadzeniu do obrotu, art. 10 ust. 10; d) spełnianie obowiązków w zakresie zgłaszania, art. 87–91; e) w przypadku badanych wyrobów – wydanie oświadczenia, załącznik XV rozdział II sekcja 4.1.
    Source: EUDAMED · non-removable
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