MDCG Publishes Guidance on Clinical Evaluation for Orphan Medical Devices
The MDCG has published MDCG 2024-10, providing guidance on the clinical evaluation of orphan medical devices, including recommendations on clinical evidence generation, study design, post-market clinical follow-up and benefit-risk assessment under the MDR.
Proposed MDR Article 50 Raises Concerns Over Notified Body Independence and Financial Sustainability
A new legal opinion analyses the European Commission’s proposed MDR Article 50, highlighting potential impacts on notified bodies, SMEs, certification costs, and conformity assessment access.