medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Borderline

The MHRA’s new guidance on standalone software as medical device and DIA Euromeeting update

The unfinished internal market for medical devices

A medical device is medical – but what does that mean?

New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details

EU court decides another borderline case regarding “pharmacological effect”

EU court AG concludes in borderline case – “intended use by nature”?

New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

EU court to clarify medical device / drug borderline and the status of MEDDEV documents

New EU Commission guidance on medical devices borderline products and classification

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