How are Medical Device Companies Complying with Eco-Compliance Legislation Around the Globe?Author: Krista Crotty
Date Published: 9/16/2015 Conference: Medical Electronics Symposium
With the recast of the EU's Restriction on the use of certain Hazardous Substances (RoHS), as well as the 2010 Commission Decision (2010/571/EU) revising the exemptions, medical device are now in scope of the directive. In addition to "RoHS-II", medical device companies should also be aware of EU REACH, and public companies should be wary of the USA’s Dodd-Frank Act which addresses Conflict Minerals. All in all, medical device companies must take a second look at their product eco-compliance initiatives.
In addition to producing compliant products, medical device companies must now provide a technical compliance file (TCF) which is much more than simply stating products are compliant. This is the largest paperwork-burden on Industry since the the original publication of the RoHS Directive in 2006. The TCF requires companies to show proof of compliance which has not been a requirement to date. To create the TCF, companies must gather information again from their supply chain to answer question of compliance.
The presentation assesses the various aspects of the EU ROHS TCF, how using a system of tracking materials helps companies stay ahead of the changing legislation, and a few examples of companies against which to benchmark.
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