On April 16, 2016, EU Published Commission Delegated Directive (EU) 2016/585: 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. This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Requirement as Below: 

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, and 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.

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.

Annex IV to Directive 2011/65/EU is amended as follows: 

1. point 31 is deleted;

2. the following point 31a is added:

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 micro scopes 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