ISO 14971 2007 FREE PDF ISO

In this context, attention of the standard formulators is drawn to the decision of European Court of Justice in case no. Thus the removal of economic considerations from the risk management process is not in tune with the legislative intent of the directive.ĪSPECT 2: JUDICIAL DECISION ON ALARP Item 3 of CD# 3 prohibits the use of ALARP by NBs in the assessment of the Risk Management undertaken by manufacturers. The text of the relevant part of the Guide is available at This would provide the parties to the dispute the opportunity to defend their interests and to enable the Community judicature to exercise its power of review. The purpose is to enable any person concerned to ascertain the circumstances in which the enacting institution exercised its powers as regards the act in question. Regulations, directives and decisions must state the reasons on which they are based. They are placed between the citations and the enacting terms. The recitals are the part of the act which contains the statement of reasons for the act They shall not contain normative provisions or political exhortations. The purpose of the recitals is to set out concise reasons for the chief provisions of the enacting terms, without reproducing or paraphrasing them. The legislative value of a recital has been defined by the Joint Practice Guide: Guide of the European Parliament, the Council and the Commission for persons involved in the drafting of legislation within the Community Institutions. Therefore there is a clear conflict between the text of the CD# 3 and the text in the recital. Take into account Technical and Economical Considerations compatible with a high level of protection and safety Take into account Technology and practices existing at the time of design of the device b.

This recital clearly states that the reduction in the risks must be interpreted and applied in such a way to a. On of the directive the first recital originating on the page reads as Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety

Kanwal Jit Singh that is being referred to in this blog is 1993L0042 -EN - 005.001 The version of the directiveĬ 603 Mithras Park, Rahatani Road, Pimpale Saudagar, Pune, 411027, INDIA Phone: +91 20 4674 3310 / +91 98204 44331 Email: īringing fresh insights to add economic value by asking the right questions This blog examines this premise with reference to the legal interpretations available today of the EU Regulatory Framework. The content deviation has interpreted that the “as far as possible” in the first indent of Section 2 of Annex 1 implies the absence of economic considerations.

Inform users of the residual risks due to any shortcomings of the protection measures adopted.ĪSPECT 1: CD$# 3 not in tune with the EU Legislative Requirements. Where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: -Įliminate or reduce risks as far as possible (inherently safe design and construction), The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. Section 2 of Annex 1 to MDD read as follows 2. Essential Requirements require risks to be reduced 'as far as possible' without there being room for economic considerations.Īccordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and various particular. The ALARP concept contains an element of economic consideration.

ISO 14971 2007 FREE PDF ISO

Kanwal Jit Singh EN ISO 14971:2012 – Content Deviation # 3 – IS IT IN TUNE WITH EU REGULATORY FRAMEWORKĬontent Deviation # 3 reads as follows Risk reduction 'as far as possible' versus 'as low as reasonably practicable': a)Īnnex D.8 to ISO 14971, referred to in 3.4, contains the concept of reducing risks 'as low as reasonably practicable' (ALARP concept).

Iso 14971 2007 free pdf