Issue formal legal statement declaring device compliance with EU regulatory requirements for CE marking.
Standard Number | Standard Name |
---|---|
EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes |
ISO 14971:2019 | Medical devices - Application of risk management to medical devices |
IEC 62304:2006 | Medical device software - Software life cycle processes |
IEC 62366-1:2015 | Medical devices - Application of usability engineering to medical devices |
Do I need to translate my EU Declaration of Conformity for different EU markets?
When exactly can I issue my EU Declaration of Conformity?
What happens if I need to update my EU Declaration of Conformity?
Who has the authority to sign the EU Declaration of Conformity?
How long must I keep my EU Declaration of Conformity?