European Institutions have been very active since 2001 in regulating environmental aspects of products and in particular electric and electronic equipment, recognizing the need to start integrating environmental consideration at the design stage and applying the "polluter pays" principle.

• 2002 the WEEE and RoHS Directives regulated the end of life of EEE and the use of 6 hazardous substances.
• 2005: the EuP Directive (now ErP) introduced requirements on energy efficiency and other environmental aspects in the design phase.
• 2006: REACH regulated all chemicals with specific requirememnts for manufacturers of articles such as medical devices.
• 2009: the ErP Directive was revised and its scope extended to energy-related products (e.g. windows, insulation).
• 2011: a project to define criteria for green public procurement of medical devices was launched by the European Commission. 
• 2011: the Basel Convention started a project to define requirements for the shipment of used electrical and electronic equipment (including medical devices).
• 2011/2012: the review process for the WEEE and RoHS Directive concluded with the extension of the RoHS scope and new requirements for the shipment of used medical devices.

WEEE II DIRECTIVE (2012/19/EU)

The WEEE II Directive introduces new obbligations for Member States and manufacturers of medical devices and more ambitious targets for collection, recovery and recycling. Annex VI provisions risk to hamper the refurbishment of used MDs.

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ROHS II EU DIRECTIVE (2011/65/EU)

RoHS II Directive bans 6 substances from medical devices starting from 22 July 2014. COCIR members have requested 12 additional exemptions for specific applications of the banned substances for which there are no alternatives.

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ERP EU DIRECTIVE (2009/125/EC)

The Ecodesign Directive (ErP) establishes a framework for the setting of ecodesign performance requirements for energy using and energy related products. Medical devices falls into the scope of the ErP Directive but have not been addressed by implementing measures setting minimum efficiency values.

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REACH EU REGULATION (1907/2006/EC)

The REACH Regulation substitutes all the existing EU legislation on chemicals setting new obligations for manufacturers and user of chemicals. Starting from 2010, only chemicals which risks are proven to be controlled can be placed on the EU market, imported or used. Medical devices manufacturers are required to collect information on chemical content from the supply chain and to pass the information to customers.

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EU GREEN PUBLIC PROCUREMENT

In May 2011 the European Commission started a project to develop environmental criteria to be used in Green Public procurement of Medical Devices. Criteria can be used by purchasers to favour environmental performing products in tenders.

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INTERNATIONAL BASEL CONVENTION

The Basel Convention, signed by more than 190 Countries, establishes common procedure for the control of transboudary shipments of hazardous waste. A new Technical guidance on shipment of e-waste risk hampering the shipment of used medical devices for reuse, refurbishment and remanufacturing.

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