Maria Donawa publishes LinkedIn article on Proposed MDR Amendments and Clinical Data Requirements

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘Proposed MDR Amendments and Clinical Data Requirements.’

Following Dr. Donawa’s February 2025 LinkedIn article on the current MDR’s clinical data requirements, the Commission’s December 2025 proposed MDR amendments have now been reviewed with particular attention to clinical data and clinical evaluation. While the proposal introduces useful amendments, it unfortunately does not alter the blanket requirement for clinical data, irrespective of classsification. This article discusses the proposed changes most relevant to manufacturers.

The article also received top billing on the LinkedIn ‘MedTech Leading Voice‘ Newsletter published on 4 January 2026.

A copy of the article can be obtained from here.