There’s no getting around it – if you want to sell medical devices in the European Union, you need a “Conformité Européenne” (CE) mark. It’s your declaration that your device complies with the requirements of all relevant European Medical Device Regulations and/or Directives, especially the new Medical Devices Regulation (2017/745/ EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR).
As with any bureaucratic process, the road to certification can be long, complicated, and confusing – even knowing where to begin can be a challenge. Fortunately, we’ve put together a whitepaper that lays out exactly what you need to do, when you need to do it, and who you should consult if complications arise.
Download the whitepaper here and get your journey to conformity started on the right foot.
