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Commission Delegated Directive (EU) 2016/585 of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes (Text with EEA relevance)

Commission Delegated Directive (EU) 2016/585 of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes (Text with EEA relevance)

Delegated Directive (EU) 2016/585 · Directive · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish, by 28 February 2017, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions. They shall apply those provisions from 6 November 2017. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Article 4

This Directive is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX Annex IV to Directive 2011/65/EU is amended as follows: (1) point 31 is deleted; (2) the following point 31a is added: ‘31a. Lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. Expires on: (a) 21 July 2021 for the use in medical devices other than in vitro diagnostic medical devices; (b) 21 July 2023 for the use in in vitro diagnostic medical devices; (c) 21 July 2024 for the use in electron microscopes and their accessories.’

Implementing measures in the Member States

Transposition links come from the Member States’ notifications published on EUR-Lex. Only high-confidence matches held on LawPlayer are listed; see EUR-Lex for the complete list.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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