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Global 'Essential Principles' Of Safety And Performance: IMDRF Sheds New Light

 
• By Neena Brizmohun

An updated guidance document from the International Medical Device Regulators Forum seeks to support global convergence on the guidance documents and standards that companies can use to meet "essential principles" of safety and performance for medical devices and IVDs.

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The IMDRF has revised its essential principles guidance

The International Medical Device Regulators Forum is updating its five-year-old guidance document on how to ensure that devices and IVDs conform to the "essential principles" of safety and performance, and the group wants public input.

The revised guidance (GRRP WG(PD1)/N47), which identifies and describes the essential principles of safety and performance that need to...

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