The EU has released the Regulations (EU) 2021/2282 “oon health technology assessment an amending Directive 2011/24/EU. With relation to MDR/IVDR, this is related to joint clinical assessments for Classs IIb or III devices (MDR) and Class D (IVDR). Criteria that can affect clinical assessment include (i) first in class, (ii) AI, Machine Learning use in software, (iii) new medical needs (iv) first in class and (v) EU-wide value.

🔗 Original Document :  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2282