Understanding ISO 14971:2007 - A Key Framework for Risk Management

The European Union Regulatory Framework has a significant impact on manufacturers of medical devices. In recent years, there have been changes in the interpretation of certain clauses within this framework, particularly with regards to risk management. One such change is the redefinition of 'as far as possible' in Section 2 of Annex 1, which implies the absence of economic considerations.

The concept of eliminating or reducing risks as far as possible is a key principle in ISO 14971:2007, which provides a framework for risk management in medical device design and construction. This standard requires manufacturers to identify and mitigate risks associated with their devices, taking into account the generally acknowledged state of the art. In selecting solutions, manufacturers must apply the following principles in order: eliminate or reduce risks as far as possible, then consider the use of alarms if necessary.

However, there is a significant difference between the ALARP (As Low As Reasonably Practicable) concept and the requirement to reduce risks 'as far as possible'. The ALARP concept takes into account economic considerations, whereas the latter does not. This has important implications for manufacturers and Notified Bodies, who must ensure that their risk management strategies comply with the EU Regulatory Framework.

In conclusion, ISO 14971:2007 provides a comprehensive framework for risk management in medical device design and construction. Understanding the principles of this standard is essential for ensuring compliance with the EU Regulatory Framework and protecting patients from potential harm. By following the guidelines outlined in this standard, manufacturers can ensure that their devices are safe and effective while also taking into account economic considerations.

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