The need for assessing medical device risks and hazards to the end user (patient), the medical team, or the environment are key factors to assure regulatory conformity for both medical devices and IVDs.
Risk Management is a fundamental part of a medical device’s technical documentation and conformity with the General Safety and Performance Requirements (GSPR) of both the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD medical device Regulation 2017/746 (IVDR). This has been a requirement now for many years under the EU Directives, but has been overlooked by many manufacturers of low-risk and simple devices. However, it must be remembered that there is no excuse for any manufacturer of medical devices not to assess the risk and hazards relating to their product.
When carrying out Risk Management for medical devices and IVDs, one must consider the state of the art ISO 14971 standard by default. This standard has been used for many years; recent versions have changes which are essential if coverage of the EU Regulations is to be sought. Always ensure that you are referring to the latest version of the standard. But do keep in mind that the latest version of the standard is not always harmonised for the EU, so you may need to refer to both.
A Risk Management File will consist of, at least, the following:
- Risk Management Plan.
- Risk Identification and Analysis.
- Risk Management Report.
All sections shall be robust enough to demonstrate compliance with the EU Regulations. A key element of this is Risk Identification and Analysis, which should be considered as a ‘live’ document continuously being updated throughout design, production, post-market phases. This will typically involve a multi-disciplined team brainstorming session of risk identification, followed by an analysis of the probability and severity of these risks, and a mitigation stage. Tailoring an existing system to ensure updates to this file is essential for ongoing compliance.
Notified Bodies will always be looking for a full risk analysis study to show that all risks and hazards have been considered, even inconsequential ones, and that the question of residual risks after all mitigating actions have been addressed, including those incorporated within the instructions provided with the device, or on the label.
Risk Management is also a key element to ensure that you will be covered for any product liability claims and would normally be regarded as essential by a manufacturer’s insurance provider.
Advena are specialists in undertaking risk management studies to EN ISO 14971 and should you require assistance with this or with updating your system to accommodate ongoing activities please ask the team for a quotation. It cannot be emphasised enough the importance of this element in showing conformity to the Regulations, both in the EU and throughout the world.
For more information, please contact the Advena team:
