Medical Device News – November 2023 Regulatory Update

Medical Device made Easy Podcast · Nov 9, 2023

EU:

UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197

EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf

MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf

Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT

Notified Bodies : Finland and Turkey

Sertio Oy (Finland) IVDR…