COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices

Information

Type

Delegated directive

Regulated products

Medical Devices

Published

August 11, 2021

Last updated

August 11, 2021

Description

This document is a delegated directive that amends Annex IV to Directive 2011/65/EU regarding the use of certain phthalates in medical device spare parts.

Organization

Country / Region

European Union

License

Creative Commons Attribution 4.0

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