COCIR Recommendation Applicability of EHSR of the Machinery Directive (2006/42/EC) to Medical Devices

According to the Medical Device Regulation (MDR), medical devices that are also machinery shall also meet the Essential Health & Safety Requirements (EHSR) of the Machinery Directive to the extent to which those EHSRs are more specific than the General Safety & Performance Requirements (GSPR) set out in Annex I of the MDR. COCIR has developed a recommendation to provide detailed guidance which EHSR of the Machinery Directive are considered more specific and therefore have to be addressed by medical devices, which also meet the definition of machinery. The document is part of the COCIR effort to support our members with practical guidance towards the implementation of the MDR, which will apply from May 2020.