2. Is EC-certificate required to sell a medical device in the EU?
Yes. The EC-certificate indicates that the medical device has undergone the necessary conformity assessment by a Notified Body for certain classes of devices, and that it meets the requirements for safety, performance, and quality as specified in the relevant EU regulations. Without a valid EC-certificate, a medical device cannot be placed on the market or put into service within the EU.
3. What medical devices require a EC-certificate?
Notified Bodies issue certificates following audits and inspections, ensuring that devices meet the safety and quality standards outlined in the two EU medical device regulations. As a result, only certain classes of medical devices undergo these audits and inspections and subsequently receive certification.
Devices subject to audits and inspections include those categorized as class IIa, IIb, or III, as well as specific Class I devices with certain characteristics. Class I devices that are sterile, have a measuring function, or are intended for reuse as surgical instruments are among those requiring certification.
Class I devices that do not fall into these categories do not require certification by a Notified Body. While they must still comply with relevant regulatory requirements and adhere to quality management systems, they are subject to self-certification by the manufacturer. These devices are not certified and do not require EC-certificates.
4. How do EC-certificates relate to CE marking?
The relationship between EC certificates and CE marking is that EC certificates are often a necessary component of the CE marking process. CE marking indicates that a product complies with European Union medical device standards, allowing it to be legally marketed within the EU. EC-certificates serve as evidence that a product meets the EU requirements. Therefore, obtaining an EC certificate is typically a prerequisite for affixing the CE-mark to a product (except class I).
5. Who issues EC-certificates?
Notified Bodies are responsible for issuing certificates that are sometimes (see question 1) referred to as EC-Certificates.
6. How long is a EC-certificate valid?
In the existing framework, EC-certificates issued by Notified Bodies typically remain valid for three years, although for certain high-risk devices, this validity period may be reduced to one year. However, it's crucial to note that the status of your CE certification is contingent upon maintaining certification of your quality system.
7. What can invalidate my EC-Certificate?
Non-compliance with regulatory requirements. If the medical device manufacturer fails to maintain compliance with relevant regulations, standards, or quality management system requirements, the Notified Body may revoke the certificate.
Significant changes to the medical device design, intended use, manufacturing process, or other critical aspects may require re-evaluation by the Notified Body. Failure to notify the Notified Body of such changes or obtain their approval may result in certificate invalidation.
Besides, if there are significant changes to regulations or standards that affect the certification requirements for the medical device, the Notified Body may reassess the device's compliance and potentially invalidate the certificate if necessary updates are not made.
In extreme cases, if the NB loses its designation or accreditation status, any certificates issued by that NB may become invalid. In such cases, manufacturers may need to seek certification from a different NB to maintain compliance.
8. Will switching contract manufacturers affect my EC-certification?
Yes, as this constitutes a change in critical suppliers. In such circumstances, Legal Manufacturers (i.e., the entities responsible for the CE marking) will select a new contract manufacturer according to criteria outlined in their quality system, which should delineate the process for qualifying and continually evaluating suppliers.
The Legal Manufacturer must inform their Notified Body of this change and request an updated EC-certificate. The Notified Body may necessitate an on-site audit of the new contract manufacturer to issue the updated EC-Certificate.
