Medical Devices Update: New Guidance for Medical Device Standards in the EUMedical Devices Update: New Guidance for Medical Device Standards in the EU

The MDCG has released a revised document (MDCG 2021-5 Rev. 1) offering guidance on using standards to comply with EU medical device regulations.

This document covers key areas like:
– EU Legislation & Standards: Explains the role of harmonized European standards in supporting the “New Approach” and “New Legislative Framework” for medical devices.
– Voluntary Use & Legal Weight: Clarifies the voluntary nature of using standards while also highlighting the presumption of conformity granted by published harmonized standards.
– Standards Development & Governance: Provides insights into the development process for harmonized standards and the role of the MDCG Subgroup on Standards.

Note: This is a non-exhaustive summary and should be read in conjunction with the full document and relevant legal frameworks.

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