Enews - 02 May 2013 On 31 July 2012 EN ISO, Medical devices — Application of risk management to medical devices, replaced EN ISO as the European harmonised standard. The 2009 version was considered obsolete as of the same date. The 2012 version allows the presumption of conformity to the applicable Essential Requirements of the three Medical Device Directives, 90/385/EEC, 93/42/EEC and 98/79/EC. EN ISO applies only to manufacturers placing devices on the market in Europe; for the rest of the world, ISO remains the applicable standard.

ISO 14971: Medical devices - Application of risk management to medical devices. BS EN 12442-1 November 15, 2000. Find the most up-to-date version of CEI UNI EN ISO 14971 at Engineering360. ISO 14971: Medical devices - Application of risk management to medical. A presumption of conformity to aspects of the various device directives), is EN ISO. Buy CEI UNI EN ISO 14971 Ed. 4 (2012) Medical Devices - Application Of Risk Management To Medical Devices from SAI Global.

We describe below the steps BSI as a medical devices notified body plans to take to meet the requirements of EN ISO. This should help manufacturers update their risk management procedures and files to maintain compliance with the Essential Requirements of the directives. Nucor At A Crossroads Pdf Writer. What is the difference between EN ISO, EN ISO and ISO?

There has been no change to the Normative Text of the standard; the Normative Text contains the requirements and is the same in all three versions. Only the Annex Zs of EN ISO 14971 have changed in the 2012 version. The new Annex Zs describe where the EN ISO 14971 standard does and does not meet the requirements of the European Directives. The Annex Zs describe these differences as Content Deviations for each Directive. What does this mean for future BSI Quality System or Technical Documentation Audits and Design Dossier Reviews?

The role of the Notified Body is to assess compliance to the Directives, focusing on risk management and whether clinical benefits outweigh risk to patients and users. Manufacturers should have read the new harmonised standard and can then choose to use the harmonised standard to help meet the requirements of the Directives.

The latest harmonised version has clarified the gaps. BSI QMS Assessors and Technical Specialists will be asking questions in upcoming audits and reviews that ensure that manufacturers who place devices on the market in Europe are aware of the gaps between the requirements of the standard and those of the Directives, and that manufacturers have undertaken (or are undertaking) any actions needed to address these. Key questions will include: • Have risks been designed out if possible? • Have manufacturers shown that risks have been reduced as much as possible?

• Have manufacturers conducted a risk benefit analysis for all risks? • Have residual risks been incorrectly reduced by warnings placed on IFUs or provided in training? The wording in the Directives has not changed and some manufacturers will have procedures and risk management files that already comply. Others may have corrective actions to take. Please be ready at your next BSI QMS or Technical File Assessment to share evidence to show that EN ISO Annex Z has been considered in your compliance to the Essential Requirements for newer devices and to share your plans for evaluating and addressing the impact of EN ISO Annex Z on older and legacy devices that will continue to have CE Marking applied.

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.