Requirements
Many product requirements require the manufacturer to implement a quality management system:
- For medical devices including invitro diagnostics, the requirement is to meet BS EN ISO13485+A11:2021.
- For most non-medical products, the requirement is to meet BS EN ISO9001:2015+A1:2024.
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Other documents
For medical devices other documents need to be taken into account including:
- MEDDEVS issued by the European Commission and adopted by the UK
- Medical device guidance documents issued by the GHTF (Global Harmonisation TSK Force)
- Applicable Harmonised Standards approved by the UK and or EU
For non-medical equipment, the relevant harmonised standards need to be complied with or a satisfactory reason for exclusion provided.
MEDDEVS can be obtained here.
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