The European Commission’s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017/746), being effective from 26 May 2022, is a ‘legislative framework’ replacing the previous IVD directive that existed, was originally developed to address the global need for safe, reliable, and effective IVDs in the market. IVDR being exhaustive and transparent, brings regulatory changes and requirements to improve safety and efficacy of IVDs for economic operators and non-EU manufacturers with commercial operations in the European Economic Area (EEA).
In this whitepaper, we present a deep dive into this In Vitro Diagnostic Regulation (EU IVDR 2017/746) ‘legislative framework.’ Specifically, the paper covers the following topics:
- An overview of the new framework
- The role of EQMS in meeting the regulatory requirement
- IVDR’s risk-based approach and new product classification
- The role of audits and inspections
- How will this affect the supply chain?
This whitepaper aims to facilitate manufacturers to understand, review and prepare for necessary audits, technical documentation, certifications, device classification, QMS, etc. required by the various articles and annexes under IVDR.