11 March 2026
Accreditation Procedures According to European Regulations for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)
If the company wishes to rely on European Regulations for:
Class I Medical Devices (Non-Sterile):
Excluding devices with a Measuring function or Reusable Surgical Instruments, it is not required to submit an ISO 13485:2016 certificate.
The company must submit the following:
EU Declaration of Conformity according to Annex IV MDR.
Class I Medical Devices (Non-Sterile):
Excluding devices with a Measuring function or Reusable Surgical Instruments, it is not required to submit an ISO 13485:2016 certificate.
The company must submit the following:
EU Declaration of Conformity according to Annex IV MDR.
A guidance template can be viewed via the following link: [MANUFACTURER’S DECLARATION OF CONFORMITY according to MDR]
- Free Sale Certificate (FSC) issued by a Reference Country if the device is subject to registration; or a Free Sale Certificate from the Country of Origin if it is not subject to registration.
Medical Devices and Diagnostic Reagents (All Classifications):
Regarding quality and marketing certificates, the following must be submitted:
In the absence of a Free Sale Certificate (FSC) issued by a European Reference Country, a Certificate to Foreign Government (CFG) issued by the U.S. Food and Drug Administration (FDA) may be submitted as an alternative. This must be accompanied by all other required quality certificates and documents for registration or importation procedures.