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SAFEGUARDS | Electrical and Electronics NO. 186/15

SafeGuardS lady looking microscope

On 16 October 2015, the European Commission notified the World Trade Organization of revisions to Annex IV of the Restrictions of Hazardous Substances (RoHS) Directive. Annex IV to Directive 2011/65/EU is amended to delete point 31 and the point 31a is added.

Since the Commission received an application in June 2013 in relation to use of spare parts in medical devices in the context of RoHS; the use of spare parts as requested in the application is different than exemption 31 in Annex IV. This application follows the requisite technical and scientific assessments, including a stakeholder consultation.

The final report, prepared by consultants Oeko Insitute and approved by DG Environment, asked for the evaluation of this application and requested a further comprehensive study to be prepared on the broader issue of refurbishment of medical devices in the context of RoHS. These are available on the consultants’ webpage. Following this, stakeholders and Member States were notified.

Annex IV to Directive 2011/65/EU, point 31 is deleted and point 31a is added to include the date of expiry, as follows:

  • Medical devices to 21 July 2021
  • In vitro diagnostic medical devices to 21 July 2023
  • Electron microscopes and their accessories to 21 July 2024

The proposed date of adoption would be in January 2016.

Source: Notification Reference G/TBT/N/EU/320

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