No Free Pass: Why Most Self-Certified IVDs Must Comply with the EU IVD Regulation by May 2022
The new European In Vitro Diagnostic Regulation (IVDR 2017/746) goes into effect on May 26, 2022. At that time, 80-90% of all IVD manufacturers will be reclassified to Class B or higher and therefore require an audit by a European Notified Body approved to conduct audits for IVDR compliance (see current list). While manufacturers of List A and B devices under the In Vitro Diagnostics Directive (IVDD 98/79/EC) are accustomed to the rigors of a Notified Body audit, they are currently […]
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