Assessment of the Technical Documentation within the MDR conformity assessment procedure

How to Achieve EU Market Access for Medical Devices

How to Achieve EU Market Access for Medical Devices

ASSESSMENT OF THE MDR TECHNICAL DOCUMENTATION WITHIN THE MDR CONFORMITY ASSESSMENT PROCEDURE

For products that are classified as Class II/III medical devices the Medical Device Regulation (MDR) requires an assessment of the technical documentation within the scope of the conformity assessment procedure to place devices on the EU market.

To bring medical devices into the EU market, depending on the classification and chosen conformity assessment procedure the legal manufacturer may need an additional EU technical documentation assessment certificate besides his EU quality management or quality assurance system certificate.

In the case of initial product certification the process starts with a combined pre- application and application phase to ascertain that a product can be certified from a regulatory point of view.

In the case of modification of a certified product the process starts directly with the change related application phase.

The next step in both processes is the assessment of the technical documentation. A positive result of the review and the independent certification decision enables the issuance of the related certificate.

Pre-Application Phase

You have a new medical device (initial certification)

Please start with the Pre-Application Phase

Pre-Application Phase

Application Phase

You have changes on a certified medical device (change notification)

Please start with the Application Phase

Application Phase

Next Steps

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