Take the mystery out of applying for a CE mark
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.