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EU Commission Exempts Lead Restrictions in Certain Medical Devices

The Commission of the European Union (EU) has issued a limited exemption for the use of lead in certain materials used in specific medical devices.

Published in April 2015 in the Official Journal of the European Union, Delegated Directive 2015/573 will permit until the end of 2018 the continued use of lead as a stabilizer in the processing of polyvinyl chloride (PVC) used in certain in-vitro medical analytical devices, specifically, sensor cards used in conjunction with blood, body fluid and body gas analyzers.

EU Directive 2011/65/EU restricts the use of lead and other hazardous substances in electrical and electronic equipment. However, according to the Commission, the performance of tested alternatives to lead stabilizers or to PVC do not meet the specific technical requirements of these important medical devices. Although research into possible substitutes is ongoing, additional time is needed to identify alternatives that meet the required performance standards, hence the limited exemption.

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Read the complete text of the EU Commission’s Delegated Directive regarding the use of lead in certain medical devices.

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