1. Expansion of Product Scope
1.1 New Class 8 Medical Devices, Class 9 Surveillance and Control Instruments (including Industrial Monitoring Instruments), and Class 11 Other Electrical and Electronic Products are added.
See the chart below for the scope of products covered by 2011/65/EU.
1.2 Transition period for Class 8 and 9 products:
1) Medical devices: July 22, 2014
2) In-vitro diagnostic medical devices: July 22, 2016
3) Surveillance and control instruments: July 22, 2014
4) Industrial surveillance and control instruments: July 22, 2017
1.3 Twenty exemptions are proposed for products in categories 8 and 9, as detailed in Annex IV of 2011/65/EU.
2. Clarification of some definitions
Clarification of the definitions of "electrical and electronic equipment (or EEE)", "large stationary industrial tools", "industrial equipment", "large stationary industrial tools" and "large stationary industrial equipment". tools", "large fixtures", "cables", "manufacturer", "authorized representative" and 28 other terms.
3. Deleted the provisions of the manufacturer (producer), and added "manufacturer" (manufacturer), "authorized representative" (authorised), "authorized representative" (representative), "authorized representative" (authorized), "authorized representative" (authorized), "authorized representative" (authorized), "authorized representative" (authorized), "authorized representative" (authorized), "authorized representative" (authorized) and "authorized representative" (authorized). Representative" (authorized representative), "importer" (importer), "distributor" (distributor), and clearly defined their responsibilities.
See Articles 3, 7, 8, 9 and 10 of 2011/65/EU for details.
4. Provides for the need to affix the CE marking to products and matters relating to the CE marking
Article 14 of 2011/65/EU sets out the general principles for the affixing of the CE marking, which must be in accordance with the general principles set out in Article 30 of Regulation (EC) No 765/2008, and Article 15 of 2011/65/EU sets out the rules and requirements for the affixing of the CE marking.
5. The scope of controlled hazardous substances has not been expanded, or maintain the original six substances of the original limit requirements, but proposed the future review process, including HBCDD, DEHP, BBP, DBP four substances to prioritize the examination, for the directive in the future to expand the scope of controlled substances to pave the way. At the same time consider the compatibility with REACH.