ARTICLE SUMMARY:
After eight years of industry clamor for MDR/IVDR reform, there are some signs of movement: MedTech Europe execs express cautious optimism that concrete changes may be in the offing; we review the EU MDCG's new guidance on structured dialogue for notified bodies and a draft EC regulation on electronic labeling. Also inside, implementing Phase 0 analysis before embarking on clinical modernization initiatives; whiplash at CDRH; and a graphic look at device approvals in China.
