Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR

Overview

Transitioning devices
This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia.

Complete this form if you are a sponsor or agent seeking to utilise TGA’s web publication service to provide market notifications to health care providers and/or end users as a result of your devices transitioning from the EU MDD to the EU MDR.

Non-Transitioning devices
This form can also be used to provide market notifications to health care providers and/or end users of devices that are not transitioning from the EU MDD to the EU MDR and where supply of the non-transitioning device will be ceasing.

Eligibility

For transitioning devices, all the following 6 criteria must be met in order to utilise TGA’s web publication service to provide market notifications to health care providers and/or end users:

1. The changes being notified only relate to devices transitioning from the EU MDD to EU MDR certification. i.e., the changes are due to a change in regulatory requirements and not because devices currently supplied to the market are unsafe or defective, AND
2. The devices comply with all Australian regulatory requirements when supplied to the market, AND
3. There are no deficiencies in safety, quality, performance, or presentation of the devices as currently supplied to the market, AND
4. The changes being notified are not because of any reported safety related incidents that have resulted in patient or user harm, AND
5. The changes being notified are not because of any signals arising from adverse event reporting and investigation, AND
6. The devices were manufactured whilst a conformity assessment certificate was valid.

Before you start

Information collected will be published in full on our website. Please ensure that all information is accurate and suitable for public use. 

NOTE: Do not use this form if:
• You are seeking to provide market notifications for In-Vitro Diagnostic (IVD) medical devices. A separate form will be developed for IVD medical devices.