here is an ever-increasing portfolio of European environmental legislation which applies to medical device companies, ranging from importation of raw materials to end-of-life device disposal. Thus a complete understanding of these issues is important, not only to European manufacturers, but also to non-European companies that export to Europe.
Based upon knowledge of the associated voluntary standards and eco-friendly labeling programs, Donawa Lifescience Consulting (DLC) can provide advice to medical device companies on:
- Packaging directives and standards
- Electronic waste directive
- Hazardous substances
- EU chemical manufacture and importation
- EU Batteries Directive
- ISO 14001 compliance
- Environmentally conscious design
In particular for medical device manufacturers, the Restriction of Hazardous Substances (RoHS II) Directive, whch previously exempted ‘medical devices‘ from its requirements, was ‘recast’ and in January 2013, Directive 2002/95/EC was replaced by Directive 2011/65/EU, which includes medical devices within its scope from 22 July 2014 and IVD devices from 22 July 2016. The recast RoHS Direcive is also a ‘CE marking directive’, which means that when a medical device manufacturer places a CE mark on a device to indicate compliance with medical device legislation, it also means that the device in question complies with the RoHS Directive.