Medical Device News – january 2024 Regulatory Update

Medical Device made Easy Podcast · Jan 10, 2024

Medboard

Who is Medboard

Medboard: https://www.medboard.com/

EU

EU Reference laboratories EURL

EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713

Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en

Letter to EU Parliament

Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT

MDCG 2023-7 on Clinical Investigation

MDCG 2023-7 Guidance on exemptions…