What is an EC Certificate?
First off, the term EC Certificate is not a legal term but rather professional slang. Under the MDR and IVDR, this type of certification is officially referred to as a "Certificate issued by a notified body". But in this article, we’ll stick with what everyone’s used to calling it – the EC Certificate.
An EC Certificate is a formal document issued by a Notified Body confirming that a medical device complies with the applicable regulatory requirements of the European Union. It is a key component of the conformity assessment process, serving as evidence that the device meets the essential safety, performance, and quality requirements outlined in the EU Medical Device Regulation or the In Vitro Diagnostic Regulation.
Purpose of the EC Certificate
The EC Certificate authorizes the manufacturer to affix the CE marking to their device, enabling its legal placement on the EU market. The certificate demonstrates that:
- The device conforms to the applicable safety and performance standards.
- The manufacturer's quality management system is compliant with regulatory requirements.
- The technical documentation and risk management processes are adequate.
Types of EC Certificates
EC Certificates may be issued for:
- Full Quality Assurance Systems - verifying the manufacturer’s quality management system.
- Type Examination - certifying that a representative device sample meets the applicable standards.
- Product Verification - confirming that the production process consistently ensures compliance.
Devices Requiring an EC Certificate
Not all devices require an EC Certificate. This certification is generally mandatory for:
- Class IIa, IIb, and III medical devices: Higher-risk categories under MDR.
- Class B, C, and D in vitro diagnostic devices: As per IVDR classification.
Low-risk devices (Class I or Class A) do not require an EC Certificate if they do not involve sterile or measuring functions.
Validity of the EC Certificate
Typically, EC Certificates are valid for a period of 5 years. However, manufacturers must ensure ongoing compliance throughout the certificate's validity, as the certificate is subject to surveillance audits and renewal requirements.
The EC Certificate is a cornerstone of regulatory compliance, ensuring that only safe and effective devices reach the European market while maintaining patient and user safety.
