MDCG 2020-3
Guidance on significant changes regarding the transitional provision
Defines the significant changes that require a new MDR conformity assessment
- Category
- MDCG guidance
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
A significant change triggers a new conformity assessment. Examples: change of material, new indication, critical software change.
Official sources
https://health.ec.europa.eu/system/files/2020-03/mdcg_2020_3_guidance_significant_changes_en_0.pdfSee where this text lands in your roadmap
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