EU TYPE-EXAMINATION CERTIFICATE
According to the conformity assessment of the medical device through the type-examination procedure as per Annex X, the Notified Body examines and assesses the Technical Documentation, relevant life cycle processes and a representative product sample conforms to the MDR. They verify that the type has been manufactured in conformity with that documentation.
Either the Notified Body tests the necessary parameters required to check the conformity of the safety and performance or examines the test results submitted by the manufacturer.
The notified body issues the EU Type-Examination certificate to the manufacturer of medical devices if they comply with the conformity assessment specified in Annex X of MDR. This is applicable for the class III and IIb medical devices. This certificate includes clear product identification (name, model, type of device or devices), intended purpose, risk classification, and Basic UDI– DI. The re-certifications shall occur at least every five years.
If a medical device with the EU Type- Examination Certificate, for what changes on the device do the manufacturer required to inform the Notified Body? For which changes the Notified Body will issue a supplement to the EU Type-Examination Certificate?
For two criteria manufacturer require to inform Notified body:-
1. Any planned change to approved type of device
2. Any change in intended Purpose and Condition of use of approved device.
Changes to above two criteria shall require approval from the notified body who issues the EU type-examination certificate, as such changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product.
The notified body then examines the planned changes, notify the manufacturer of its decision and provide manufacturer with a supplement to the EU type-examination report. Approval of any change to the approved type of device, notified body issue a supplement to the EU type-examination certificate.
When there is any significant change, such as changes to the intended purpose and conditions of use, made to the approved product then the applicant should inform the notified body, which issued the EC type examination certificate.
If the changes are having limitations to its intended purpose and conditions of use, and thereby affecting the conformity with the general safety and performance requirements or conditions for use of the product, then the notified body should examine it against the specific requirements, if satisfied, provide its approval in the form of a supplement to the existing EU type-examination certificate.
If these changes exceeds the limitations of the intended purpose and conditions of use, then there should be a new application for the conformity assessment is required.
I have agreed with the comments of both the above responders.
The manufacture must inform when there is a change in approved type, intended purpose, and the condition of use. The notified body shall examine the planned changes, notify the manufacturer of its decision, and provide him with a supplement to the EU type-examination report. The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate.
Great article, very informative, thanks for writing. 🙂