01
What is an EC certificate?
First off, “EC certificate” is the term commonly used by medical device professionals for a certificate issued by a notified body following a successful conformity assessment. The MDR and IVDR refer to these documents collectively as certificates issued by notified bodies.
The term is therefore not the official name of one particular certificate under the current regulations. Depending on the conformity assessment procedure, the certificate may have a more specific name and scope. Nevertheless, these documents are all the same general kind of certificate, issued by a notified body as a result of conformity assessment.
The term has a historical basis. Under the former medical device directives, official certificate names included “EC.” Under the current MDR and IVDR, the corresponding certificate names generally use “EU” instead.
For simplicity, we will use the familiar term EC certificate throughout this article.
An EC certificate is a formal document issued by a notified body confirming the successful completion of a particular part of the applicable conformity assessment. Depending on the procedure, it may cover the manufacturer’s quality management system, the technical documentation for a device or device group, an examined device type, production quality assurance or product verification.
The scope of the certificate must clearly identify the devices or device groups covered. Each certificate relates to one conformity assessment procedure and may contain conditions or limitations. In some cases, more than one certificate may be required for the same device.
02
Purpose of the EC certificate
An EC certificate is an important part of the conformity assessment process for devices that require notified body involvement. It provides evidence that the notified body has assessed the manufacturer, device or relevant production controls within the scope stated in the certificate.
Depending on the type and scope of the certificate, it may confirm that:
- The manufacturer’s quality management system complies with the applicable regulatory requirements.
- The technical documentation for a device or device group has been assessed.
- An examined device type complies with the applicable requirements.
- The production quality assurance system has been assessed.
- Individual products have undergone the required verification.
- The applicable general safety and performance requirements have been addressed within the scope of the notified body’s assessment.
Completes its assessment and issues the relevant certificate
Completes conformity assessment and draws up the EU Declaration
Receives the CE marking before being placed on the market
An EC certificate does not, by itself, authorise the manufacturer to affix the CE marking. It is one element of the applicable conformity assessment procedure.
Once conformity with the applicable requirements has been demonstrated, the manufacturer draws up the EU Declaration of Conformity and affixes the CE marking. Where notified body involvement is required, the notified body’s identification number normally appears alongside the CE marking. This sequence is established in Articles 10, 19 and 20 of the MDR.
03
Types of EC certificates
Under the MDR, a notified body may issue several types of certificate, depending on the conformity assessment procedure followed:
EU quality management system certificate
Covers the assessed quality management system and the device groups included within its scope.
EU technical documentation assessment certificate
Covers the technical documentation assessment for the identified device or devices.
EU type-examination certificate
Covers the examined and approved device type.
EU quality assurance certificate
Covers the relevant production quality assurance procedure.
EU product verification certificate
Records the product examinations and tests performed under the verification route.
The IVDR follows a similar structure, although some certificate names differ. For example, the IVDR uses the term “EU production quality assurance certificate.”
These are not unrelated forms of certification. They are notified body certificates issued under different conformity assessment procedures and with different scopes.
The conformity assessment route and the certificate or combination of certificates required depend on the device classification, its characteristics and the procedure selected by the manufacturer. The applicable procedures are set out in Annexes IX, X and XI of the MDR and IVDR.
04
Devices requiring an EC certificate
Not every medical device requires a certificate issued by a notified body.
Under the MDR
Medical devices
- Class IIa medical devices.
- Class IIb medical devices.
- Class III medical devices.
- Class I devices placed on the market in a sterile condition.
- Class I devices with a measuring function.
- Class I reusable surgical instruments.
Under the IVDR
In vitro diagnostic devices
- Class B in vitro diagnostic devices.
- Class C in vitro diagnostic devices.
- Class D in vitro diagnostic devices.
- Class A devices placed on the market in a sterile condition.
Limited notified body involvement for certain low-risk devices
For Class I sterile devices, the notified body’s involvement is limited to the aspects concerned with establishing, securing and maintaining sterile conditions.
For Class I devices with a measuring function, its involvement is limited to the aspects concerning compliance with metrological requirements.
For Class I reusable surgical instruments, its involvement is limited to the aspects relating to reuse, including cleaning, disinfection, sterilisation, maintenance, functional testing and the corresponding instructions for use.
Other Class I medical devices can generally follow the self-declaration route without notified body involvement.
Other Class A IVDs can generally follow the self-declaration route. For Class A sterile devices, notified body involvement is limited to the aspects concerned with establishing, securing and maintaining sterile conditions.
Special rules may apply to certain devices, including devices incorporating medicinal substances, devices manufactured using tissues or cells, companion diagnostics, self-testing devices and near-patient testing devices.
05
Validity of the EC certificate
An EC certificate is valid for the period stated on the certificate. Under both the MDR and IVDR, this period may not exceed five years.
At the manufacturer’s request, the certificate may be renewed for further periods, each not exceeding five years. Renewal is based on reassessment under the applicable conformity assessment procedure.
Throughout the certificate’s validity, the manufacturer must continue to comply with the applicable regulatory requirements. Depending on the conformity assessment route, the notified body carries out surveillance activities, including periodic audits and assessments. Under the quality management system route in Annex IX, appropriate audits and assessments are conducted at least once every 12 months.
The notified body may restrict, suspend or withdraw a certificate if it determines that the manufacturer no longer meets the applicable requirements and the necessary corrective action is not taken within the specified period.
06
What an EC certificate does not replace
An EC certificate should not be confused with:
- The CE marking placed on the device or its packaging.
- The EU Declaration of Conformity issued by the manufacturer.
- The technical documentation maintained by the manufacturer.
- Product registration in EUDAMED or another applicable registration system.
- The manufacturer’s ongoing post-market surveillance and vigilance obligations.
These elements perform different functions within the regulatory system. A notified body certificate supports the conformity assessment, while the manufacturer remains responsible for the device’s compliance throughout its lifecycle.
In practical terms
Check the exact title and scope, not only the familiar name
An EC certificate is the commonly used professional name for a certificate issued by a notified body following conformity assessment under European medical device legislation. Although the certificates may have different formal names, scopes and issuing procedures, they belong to the same general category.
The certificate is an important part of the route to CE marking, but it is not the CE marking itself and does not replace the EU Declaration of Conformity. The exact certificate or combination of certificates required depends on the device classification, the selected conformity assessment procedure and the scope of notified body involvement.
