Having a Strategy for Regulatory Compliance is a new requirements clearly mentioned in the European Medical Device Regulation (EU MDR 2017/745) and EU IVDR 2017/746 (European In Vitro Diagnostic Regulation).

Introduction to MDR QMS Requirements A complete and comprehensive understanding of the EU MDR QMS requirements is becoming essential for an effective implementation of the New European Medical Device Regulations. We

Who are Economic Operators according to EU MDR? The term Economic Operators is explained in article 2 of EU MDR and IVDR and it refers to manufacturers, authorised representative, distributors

New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with a new framework of requirements which need to be implemented for

Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity requirements appeared, first by