Expert Insights | Eu

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
New Guidance Released on EU MDR Vigilance Terms and Concepts
blocks spelling out guidance
EU

New Guidance Released on EU MDR Vigilance Terms and Concepts

March 2, 2023 5 min read
EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?
european union flag flying next to building
EU

EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?

March 2, 2023 3 min read
Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR
doctor using tablet in medical room
EU

Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR

February 2, 2023 3 min read

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