Risk Management and EN ISO 14971:2012
The need for assessing Medical Device risks and hazards, both to the end user (patient), the medical team (doctors or nurses) or the environment are key factors to assure Medical Device regulatory conformity.
This has been a requirement now for many years but has been overlooked by many manufacturers of 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.
This is a key element to assure that you will be covered for any product liability claims and would normally be regarded as essential by a manufacturer’s insurance provider.
The state of the art for risk management studies is EN ISO 14971:2012. This standard has been used for many years but the 2012 version has some changes which are essential if coverage of the new Medical Device regulations (MDR or IVDR) is to be sought.
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 corrective/preventative actions have been addressed, including those incorporated within the instructions provided with the device, or on the label.
Risk studies will always need a plan, hazard list, analysis (statistical) of probability against severity of harm for each identified hazard, and a summary report listing residual risk (as are always present) and how the manufacturer will deal with them. The Risk Management File is a living document and all data available from production and post production must be used to update this file. Tailoring an existing system to ensure updates to this file is essential for ongoing compliance.
Advena are specialists in undertaking Medical Device risk management studies to EN ISO 14971:2012 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 of a showing conformity to the regulations, both in the EU and throughout the world.