ISO 13485 LI Practice Questions - PECB Certified ISO 13485 Lead Implementer Exam

Which regulatory framework did ISO 13485:2016 primarily aim to harmonize with for the European market?

EU General Data Protection Regulation (GDPR) EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 EU Machinery Directive European Pharmacopoeia

Correct Answer:

EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746

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