The impact of the European Batteries Regulation (EU Regulation 2023/1542) to medical devices

• August 16, 2024

The EU AI Act officially entered into force! What are the compliance deadlines for MedTech manufacturers>

• August 2, 2024

FDA’s LDT PhaseOut Policy

• May 10, 2024

Evnia introduces its team members and Tuesday MedTechTips!

• May 8, 2024

Evnia summarizes MHRA’s MedTech Reform Webinar held on March 5

• March 6, 2024

Summary of the proposed changes introduced by Germany’s ”Medical Research Act”

• February 14, 2024

Evnia summarizes MDCG 2023-7

• February 9, 2024

Article 61(10): When is a Clinical Evaluation possible without Clinical Data?

• February 1, 2024

FDA updates their eSTAR templates to submit certain PMA applications

• January 12, 2024

Summary of MDCG 2021-6 Rev.1

• December 13, 2023

MDR Transition Periods – Knowledge Map

• November 3, 2023

List of Regulatory Authorities around the world

• August 28, 2023