Exemption for lead as a thermal stabiliser in PVC used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases | Amendment of Annex IV to Directive 2011/65/EU

Title of document
Draft Commission Delegated Directive 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 lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (7 pages + Annex 2 pages, in English)

Description
This draft Commission Delegated Directive concerns an application specific and temporary exemption from the RoHS 2 (Directive 2011/65/EU) substance restrictions.

Notifying member: European Union

Notification: G/TBT/N/EU/678

Objective tag
Other

Objective
Adaptation of existing legislation to scientific and technical progress, granting manufacturers adequate transition time for compliance.

Documents

• 19_4880_00_e.pdf
• 19_4880_01_e.pdf

Agency responsible
European Commission

Timing:

• Submission: 04/09/2019
• Reception: 04/09/2019
• Distribution: 04/09/2019
• Final date for comments: 03/11/2019
• Proposed date of adoption: N/A