The ISO 14971 standard applies to all medical devices and in-vitro diagnostic devices put on the market in the EU regardless of classification. Having a streamlined and clear risk management procedure helps you implement the requirements from the standard and achieve compliance with the Medical Device Regulation and In-Vitro Diagnostic Medical Device Regulation.

1. You may use this procedure template in your quality management system after adapting it to your needs and removing the informative text.

2. Use the template as an inspiration while authoring your own procedure.

3. Use the template as a benchmark to check your own existing procedure.

As a general remark, throughout this procedure, the term “hazard traceability matrix” is used for the document containing the table with risks. Some would refer to this as “the risk analysis”, or “the FMEA”. Since both “risk analysis” and “FMEA” have other meanings/definitions from standards, they are not used for the hazard traceability matrix in this procedure.

In general, you should update who is responsible for what throughout this procedure. Nothing specifically requires QA, for example, to own this process.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before using the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed, and the example text customised to work with the current project.

If you should want to learn more about using the template or risk management in general, it is covered in our online Introduction to Risk Management for Medical Devices and ISO 14971 course and our public Risk Management for Medical Devices and ISO 14971 blended course. Our blended courses combine a self-paced online course followed by a live virtual classroom session. You can also save money by purchasing our Advanced Risk Management course bundle which includes 3 online courses at a reduced price.