As standards in medical device regulation try to cope with the wide range of devices, functions and features, there is an increasing reliance being placed on subjective requirements such as risk management.
This section provides some opinions on how these standards might be interpreted. Obviously, the subjective nature of the requirement means that these should be treated as opinions only and the manufacturer should try to form their own opinion prior to implementation. Manufacturers may also seek guidance from certification bodies, although as third parties are required to remain impartial and avoid consulting, their advice is typically high level and conservative.
Subjects covered are below (see also navigation bar, right):
|Retrospective application of harmonized standards||Triggered by upcoming end of transition to EN 60601-1:2006, this article investigates whether broad based retrospective application of harmonized standards is actually required by the law, and if so, whether it is reasonable in practice.|
|MDD, essential requirements, presumption of conformity and standards||Provides explanation and history behind the concept of the "presumption of conformity", how this relates to standards, along with pointers to how to evaluate if an essential requirement is really fulfilled.|
|Essential Performance (IEC 60601-1:2005)||This article tries to make sense about a confusing new subject introduced by the 3rd edition of IEC 60601-1. Warning: Controversial material!|
|Limitations to ISO 14971||This article discusses how when resources are taken into account, risk management is not always effective. It will be updated soon based on recent refinement.|
|NRTL / CB||
This article discusses an important issues of technical competence are being overlooked in NRTL and CB scheme assessment of some of the newer standards. Warning: Controversial material!