Risk Management EN ISO 14971:2012 – Implications For Medical Device Manufacturers

Risk Management is a fundamental step for medical device manufacturers to demonstrate compliance to the EU Directives for Medical Devices, ensuring the safety of patients and users. Risk management has been conducted following the principles laid out in ISO 14971, and since the advent of the new version of EN ISO 14971:2012 Medical devices – application of risk management to medical devices, the additional clarification within the standard has led to a number of misconceptions and confusion surrounding the implementation of the new standard by medical device manufacturers. Some frequently heard comments by manufacturers on the new versions of EN ISO 14971 are:

• “We must use dFMEA (design failure mode and effect analysis) and pFMEA (production or process FMEA) from now on.”
• “All identified risks must be eliminated.”
• “We cannot use Annex C questions as we used to.”
• “We can no longer use ALARP (as low as reasonably practicable) but must use ALAP (as low as possible).”
• “All risks must be addressed by design changes from now on.”
• “We will have to go back and rewrite all our risk files.”
• “We are not allowed to put warnings in the IFU.”

As it can be seen from these comments, medical device manufacturers were left in some cases scratching their heads about how exactly they were going to implement the new standard. Did they need to rewrite all the risk analysis they had conducted so far, or did they just have to apply the new version of the standard to future risk management activities? This white paper will help medical device manufactures to understand the changes made in EN ISO 14971:2012, and provide guidance on what is expected of medical device manufacturers to comply with the standard, thereby determining the facts from the myth.