EU Declaration of Conformity for Medical Devices

EU Declaration of Conformity for Medical Devices

This declaration is in WORD format and consists of the actual CE Directives.

Additional information:

• CE directives included in this declaration:
  • Medical Device Regulation (EU) 2017/745
  • EMC
  • and RoHS II.
• Check carefully whether these directives all apply to your product - if not, remove the relevant directive(s). This declaration is based on a medical device, including electrical and electronic components. RoHS may therefore also apply to this. If it concerns a medical device in which electricity / electronics do not play a role, your declaration will probably suffice with only the mention of the Medical Device Regulation.
• Information that cannot be determined in advance (name and address details, standards used, additional information, etc.) are highlighted in yellow in the declaration.
• Complete the declaration in full and remove what does not apply to your product.