ISO 13485:2016 “Medical devices — Quality management systems — Requirements for regulatory purposes” is the quality management system standard used across the global medical device industry. EN ISO 13485:2016+A11:2021 is the European adoption, in which A11:2021 updated the annexes (Annex Z) mapping its relationship with the EU MDR/IVDR.
About the standard
ISO 13485 sets out quality management system requirements across design and development, production, storage, distribution, installation and servicing of medical devices, with emphasis on risk management, process validation and regulatory compliance. It is a basic requirement for EU MDR/IVDR conformity assessment, the MDSAP (Medical Device Single Audit Program) and registration in Southeast Asian countries; the US FDA’s QMSR (Quality Management System Regulation) has also been based on ISO 13485:2016 since 2 February 2026. The corresponding Chinese industry standard is YY/T 0287.
Applicable products and users
- Medical device and in vitro diagnostic (IVD) manufacturers
- Medical device distributors, importers and contract manufacturers
- Companies planning to enter markets such as the EU, the US and Southeast Asia
Main contents
- Quality management system documentation and records requirements
- Design and development, purchasing, production and service controls
- Risk management and process validation
- Updates in A11:2021 to the relationship with the MDR/IVDR
Where to obtain the official standard
This standard is a copyrighted publication of the International Organization for Standardization (ISO) and related standards bodies. Please purchase or consult the official text through the following official channels:
- ISO Store: ISO 13485:2016
- BSI Knowledge (British Standards Institution): BS EN ISO 13485
- Corresponding Chinese industry standard YY/T 0287 (official Chinese standards search platform)
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- EU Medical Device CE Certification (MDR/IVDR) Services
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