EU Type Examination Certificate

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.

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 File and 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.

To get an EU Type Examination Certificate, you must work with a Notified Body, which is an independent organization that has been recognized by the competent government to conduct conformity assessments. Product testing, technical documentation examination, and manufacturing process evaluation are all part of the certification process. Once awarded, the certificate certifies that the product’s design and production procedures conform with EU norms and standards, therefore contributing to the overall safety and dependability of consumer products.

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