![]() ![]() ![]() 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. 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). ![]()
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