What is a CE-Certificate?
The most important thing to know about a CE-Certificate is that it doesn't actually exist (the CE Mark exists, but the CE Certificate does not). When referring to a CE-Certificate, one might be referring to one of the following documents: an EC-Certificate (in reality, this term is also not entirely accurate - see below), an EU Declaration of Conformity, or an EU Type Examination Certificate, which is only required for specific medical devices undergoing certain regulatory procedures.
What is an EC-Certificate?
One of the steps in obtaining approval for a medical device or in vitro diagnostic medical device in Europe is an audit for compliance with MDR or IVDR requirements.
The exceptions include non-sterile and non-measuring Class I medical devices and Class A in vitro diagnostic devices. All other medical devices must be certified by a Notified Body. Following this audit, the manufacturer receives a document confirming the compliance of their quality management system and technical documentation with either the MDR (for general medical devices) or the IVDR (for in vitro diagnostic devices). This document is often referred to as the EC-certificate.
However, it is important to note that European legislation does not recognise the term "EC-certificate". In MDR and IVDR, such a document does not have a specific name and is simply referred to as "a certificate issued by a Notified Body." In other words, there is no specific term for this certificate in the EU legislation, so in professional circles, they may be referred to by different names. Sometimes it may be called an "EC-certificate," other times a "certificate EC" and sometimes, for example, a "Certificate of Compliance" or "Notified Body Certificate" - the latter one is most accurate.
Who needs an EC-Certificate to sell a medical device in the European Union
As mentioned earlier, the EC-certificate is issued after an audit conducted by a Notified Body. However, for Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments, as well as Class A in vitro diagnostic devices, an audit by a Notified Body is not required.
Therefore, manufacturers of products in the mentioned classes may do without an EC certificate. Meanwhile, for all other classes, a certificate issued by a Notified Body is mandatory.
Certification is just the final step in the process of obtaining CE marking.
It is important to remember that obtaining an EC certificate is only the last stage in the regulatory approval process for a medical device in the European Union. This step is preceded by a series of preliminary stages. One could say that the audit by a notified body and the acquisition of the EC certificate represent a concluding verification of what the manufacturer has previously undertaken to ensure compliance with European regulatory standards.
