There is an opinion among manufacturers of medical devices and in vitro diagnostic devices that a CE-certificate is required to sell products in the European Union. Sometimes, however, they talk about some kind of EC-certificate: supposedly, it is the latter that is required to enter the European market, while the CE-certificate is supposed to be either the wrong name for the CE-certificate, or a completely different certificate, or...whatever... Confusing, isn't it?
This article will tell you about the principles of certification of medical devices in the European Union and help you deal with these two certificates.
The most important thing to know about a CE certificate is that no such certificate actually exists. When someone mentions a CE-certificate, they either don't know what they are talking about at all, or they mean one of the following documents: an EC-certificate (actually, this term is not completely correct either - see below), a CE Declaration of Conformity (the correct name is EU Declaration of Conformity) or EU-Type Examination Certificate, required only for certain medical devices when passing certain regulatory procedures.
Anyway, if someone offers you assistance with a CE-certificate for your medical products and assures you that with this certificate you will be able to sell your medical devices in Europe, you should be on your guard and try to find out exactly what he means under the CE-certificate.
One of the stages of obtaining approval of a medical device or in vitro diagnostic medical device in Europe is an audit for compliance with the requirements of the European legislation. The only exceptions are class I non-sterile and non-measuring medical devices and class A in vitro diagnostic products. All other medical products must be certified by a Notified Body. Based on the results of this audit, the manufacturer receives a document confirming the compliance of its quality management system and technical documentation with the European regulations: MDR 2017/745 for medical devices or IVDR 2017/746 for in vitro diagnostic products. This document is often referred to as an EC-certificate.
Need EC REP or PRRC for the EU?
Contact us right now:
+49 176 67510274
info@mdrc-consulting.com
Thus, the statement that a manufacturer of medical devices necessarily requires an EC-certificate to sell their products in the European Union, is not entirely correct. What is required is a certificate issued by a notified body, whether you call EC-certificate, Notified Body Certificate or Certificate of Compliance.
As mentioned above, the EC-certificate is issued following an audit by a notified body. However, an audit by a notified body is not required if you manufacture class I non-sterile and non-measuring medical devices, that are not reusable surgical instruments, or class A in vitro diagnostic devices.
This means that manufacturers of products of these classes do not require an EC-certificate. For all other classes, including class I reusable surgical instruments, class I sterile devices and class I measuring devices, a certificate issued by a notified body is required.
It is important to remember that obtaining EC-certification is only part of the regulatory approval process for a medical device in the European Union. It is only a final step that is preceded by a number of earlier steps. We can say that the procedure for passing the audit by the notified body and obtaining the EC-certificate is the final check of what the manufacturer has done before in order to achieve compliance with European regulatory requirements.
We are here to help you place your medical devices on your strategic markets.
+49 176 67510274
info@mdrc-consulting.com
There is an opinion among manufacturers of medical devices and in vitro diagnostic devices that a CE-certificate is required to sell products in the European Union. Sometimes, however, they talk about some kind of EC-certificate: supposedly, it is the latter that is required to enter the European market, while the CE-certificate is supposed to be either the wrong name for the CE-certificate, or a completely different certificate, or...whatever... Confusing, isn't it?
This article will tell you about the principles of certification of medical devices in the European Union and help you deal with these two certificates.
The most important thing to know about a CE certificate is that no such certificate actually exists. When someone mentions a CE-certificate, they either don't know what they are talking about at all, or they mean one of the following documents: an EC-certificate (actually, this term is not completely correct either - see below), a CE Declaration of Conformity (the correct name is EU Declaration of Conformity) or EU-Type Examination Certificate, required only for certain medical devices when passing certain regulatory procedures.
Need EC REP or PRRC for the EU?
Contact us right now:
+49 176 67510274
info@mdrc-consulting.com
Anyway, if someone offers you assistance with a CE-certificate for your medical products and assures you that with this certificate you will be able to sell your medical devices in Europe, you should be on your guard and try to find out exactly what he means under the CE-certificate.
One of the stages of obtaining approval of a medical device or in vitro diagnostic medical device in Europe is an audit for compliance with the requirements of the European legislation. The only exceptions are class I non-sterile and non-measuring medical devices and class A in vitro diagnostic products. All other medical products must be certified by a Notified Body. Based on the results of this audit, the manufacturer receives a document confirming the compliance of its quality management system and technical documentation with the European regulations: MDR 2017/745 for medical devices or IVDR 2017/746 for in vitro diagnostic products. This document is often referred to as an EC-certificate.
It should be noted here that in fact there is no such thing as an EC-certificate in the European legislation. In the MDR and IVDR, this document is simply referred to as "certificate issued by a notified body". In other words, the term of an EC-certificate is not enshrined in legislation, it is just how people call certificates issued by notified bodies. The other names of these certificates are Notified Body Certificate or Certificate of Compliance.
Thus, the statement that a manufacturer of medical devices necessarily requires an EC-certificate to sell their products in the European Union, is not entirely correct. What is required is a certificate issued by a notified body, whether you call EC-certificate, Notified Body Certificate or Certificate of Compliance.
As mentioned above, the EC-certificate is issued following an audit by a notified body. However, an audit by a notified body is not required if you manufacture class I non-sterile and non-measuring medical devices, that are not reusable surgical instruments, or class A in vitro diagnostic devices.
This means that manufacturers of products of these classes do not require an EC-certificate. For all other classes, including class I reusable surgical instruments, class I sterile devices and class I measuring devices, a certificate issued by a notified body is required.
It is important to remember that obtaining EC-certification is only part of the regulatory approval process for a medical device in the European Union. It is only a final step that is preceded by a number of earlier steps. We can say that the procedure for passing the audit by the notified body and obtaining the EC-certificate is the final check of what the manufacturer has done before in order to achieve compliance with European regulatory requirements.
We are here to help you place your medical devices on your strategic markets.
+49 176 67510274
info@mdrc-consulting.com
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