Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲

📝 Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲 "𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝘂𝗹𝗲𝘀 𝗳𝗼𝗿 𝗶𝗻 𝘃𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝘂𝗻𝗱𝗲𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟭𝟳/𝟳𝟰𝟲" 📎 The main update has been in rule 3(f) about companion diagnostics (CDx), where more examples of CDx products and products that are not considered CDx have been added. ✏️ This revision also has a flowchart […]
Darapy-Medtech-Consulting-Logo-Principal-fondoMedBoard - Gold partner visual
DARAPY MedTech Consulting is a consulting company specialized in IVDs. We provide a wide range of services in Product Development (Immuno and Molecular Diagnostics), Regulatory Affairs, Performance Evaluation studies and Quality Assurance services from early-stage to well-established In Vitro Diagnostic (IVD) products.
Skip to content