REACH and RoHS ? Medical Device

Environment regulations, which were overlooked by medical device OEMs, have reverted with severe implications. The impact of these regulations can be as high as an upfront ban of the products, which are not REACH and RoHS compliant. Reviewed versions of REACH and RoHS regulations have made their norms stringent and obliges medical device OEMs to assess their supply chain. Presence of SVHC at any stage in the supply chain has to be reported to the regulatory bodies and end consumers within the defined time span. Granularity of information is essential aspect of REACH and RoHS regulations, and hence, knowledge about the complete supply chain is the primary requirement of medical device OEMs. REACH New regulations in the area of medical devices are compelling the medical device OEMs to have beforehand understanding of their supply chain. Medical device companies are aware of the regulatory compliance in the production front; however, areas they are unfamiliar with are environment regulations. Under the light of these regulations, they have to monitor the supply chain and track the source of raw material, followed by filing of the same to regulatory bodies. Medical device manufacturers have to anticipate, adapt to the smallest change in raw material, regardless of what phase of supply chain they find their usage. Cost of compliance to REACH and RoHS standard would increase the final price of substances, falling under these regulations. Limited number of suppliers catering to the substances, which are REACH and RoHS compliant, would bestow pricing power in their hands. Transparency in the material used in production would increase the number of counterfeit products in the market. RoHS The medical device industry was excluded from the first directive of RoHS but the recently revised directive mentions medical device in one of the 8 categories added. The deadline given to medical device OEMs for RoHs filing is July 22nd, 2014; while invitro devices have extended the timeline till July 22nd, 2016. Regulations restrict the usage of certain class of materials such as cadmium, lead hexavalent chromium, and two polybrominated flame retardants in the production of electrical and electronic parts of medical devices.