EU Declaration of Conformity for medical devices.

EU Declaration of Conformity for medical devices.

This statement is in WORD format and contains the current Guidelines.

Additional information:

• CE directives included in this declaration:
  • Medical Devices Regulation (EU) 2017/745
  • EMC 2014/30/EU
  • and RoHS II.
• Please check carefully whether all of these directives apply to your product - if not, remove the directive(s) in question. This declaration assumes 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 by only mentioning the Medical Device Regulation.
• Information that cannot be determined in advance (name, address, place of residence, standards used, additional information, etc.) is highlighted in yellow in the declaration.
• Please complete the declaration in full and remove what does not apply to your product.