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Month: November 2019

MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules

As EU medical device manufacturers and sponsors scramble to meet Medical Device Regulation (MDR) conformity in just six months, a second draft corrigenda was published on 25 November 2019 that implements many new proposed changes benefiting some EU device makers.

Key Requirements of Post-Market Surveillance under IVDR

As the new In Vitro Diagnostic Regulation (IVDR) replaces the current In Vitro Diagnostic Directive (IVDD) in 2022, there are many significant changes that IVD manufacturers must consider from a risk management perspective, as well as those pertaining to Post-Market Surveillance (PMS) to meet compliance.