CE Marking Consultants and EU Quality Management System Certificate

For the compliance evaluation of medical device manufacturers' Quality Management Systems, the notified bodies use Chapter I of Annex IX of the MDR. The notified body issues an EU Quality Management System Certificate if the quality management system meets all MDR's requirements.

It applies to all medical devices requiring involvement from a notified body during the CE marking procedure. This certificate comprises clear product identifying devices (or groups of devices), risk categorization, and intended use for class IIb. The certificate for a class Is/m/r device must identify the restrictions to the parts of the quality management system being examined. CE certifications are valid for a maximum of 5 years and are renewed annually through a surveillance audit. Under the supervision of the notified organizations, the certificate might be suspended, revoked, changed, or augmented.

CE Mark Consultants and EU TYPE-EXAMINATION CERTIFICATE

The Notified Body examines and assesses the technical documentation, relevant life cycle procedures, and a representative product sample that complies with the MDR according to the conformity assessment of the medical device using the Type-Examination technique as per Annex X.  They ensure that the type was produced following the documentation.

The Notified Body either tests the relevant criteria to ensure that the safety and performance comply or evaluates the manufacturer's test findings. This certificate includes clear product identification (name, model, type of device or devices), intended purpose, risk classification and Basic UDI- DI. The recertification shall occur at least every five years.

(Related Article - What is Clinical evaluation? When it should be conducted? )

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