MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence

2 Jan 2024 | MDCG, MDCG

Theme Clinical investigation exemption, demonstrating equivalence 
Target Audience Manufacturers
Products concerned Class III and implantable MD 
Documents mentioned

MDR (EU) 2017/745 – Article 61(4)-(6) 

MDCG 2020-5  

MDCG 2020-6  

MDCG 2020-8 

This MDCG guide aims to clarify : 

  • exemptions from the obligation to carry out clinical investigations in accordance with Article 61(4) of the MD Regulation for class III and implantable MD 
  • and the associated conditions for demonstrating equivalence, with a particular focus on demonstrating “sufficient levels of access” in accordance with Annex XIV, section 3 of the Regulation.