Electronic Medical Devices to face harsher laws in Europe

For those marketing electronic medical devices in Europe, even more stringent laws may be faced in the near future.

The European Commission are currently drafting a revised Waste Electrical and Electronic Equipment (WEEE) Directive and Restriction of Hazardous Substances (ROHS) Directive to work towards meeting higher targets for the collection and recycling of waste electricals.

ROHS, introduced in July 2006, regulates the levels of hazardous substances in electrical and electronic products, while the WEEE Directive, first issued in June 2003, provides regulation for the treatment, recovery and recycling of electric and electronic equipment.

Before the revisions, medical devices and monitoring & control instruments were excluded from the scope of the ROHS Directive. The draft revision now covers both categories, so will apply to these products. In this context, medical devices include in vitro diagnostics, but not active implantable medical devices. Provisions for the inclusion of active implantable medical devices will be reviewed by 2020. The proposed revisions for the WEEE Directive include an annual waste collection target rate of 65% of the average amount of electrical and electronic equipment put on the market in the two preceding years.

Changes to both the ROHS and WEEE are in response to studies which have found less than half the electrical waste collected in the EU is subsequently treated and target levels are being increased to meet expectations in terms of protecting the environment and health.

and continuing on environmental matters...

Europe REACHing for Greener Solutions

Closely related to ROHS and WEEE is REACH, the Registration, Evaluation, Authorisation & Restriction of CHemical substances. REACH is a relatively new European regulation, introduced in June 2007 and addresses the management of risks associated with the production and use of chemical substances. The regulation aims to improve protection of human health and the environment against potentially harmful chemicals. REACH is also involved in promoting “green chemicals” and encourages manufacturers to work towards the gradual replacement of unsafe chemicals with safer, greener chemicals

The regulation affects all manufacturers and importers of chemical substances, mixtures of chemical substances or chemical substances that make up an article. Medical devices affected by REACH range from dental filling materials and bone cements to catheters and pace makers. Any chemical substance used in a medical device which is not registered with the EU will need to go through an extensive registration process, requiring detailed technical data and results of testing for the safety of its use.

A number of REACH Annexes, which include technical guidances, are currently being reviewed. More information about REACH can be found on the European Chemicals Agency (ECHA) website.

Worried about compliance with European environmental regulations? Contact us for advice on how these changes may affect your business.