The European Commission has published two revised directives (EU) 2015/573 and (EU) 2015/574 to amend Annex IV of Directive 2011/65/EU on the 10th of April 2015, The two items are added to Annex IV. The annex is specific to the medical devices and monitoring and control instruments of RoHS 2.
Amendments
In Annex IV of Directive 2011/65/EU, the following points (41 & 42) are added:
| Amended exemptions | Revised directive | Exempted uses | Expires time |
| 41 | (EU) 2015/573 | Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. | Expires on 31 December 2018. |
| 42 | (EU) 2015/574 | Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50MHz) modes of operation. | Expires on 30 June 2019. |
Exemptions Validity Periods
Measures adopted in accordance with RoHS shall, for categories 1 to 7, 10, and 11 of Annex I, have a validity period of up to 5 years and, for categories 8 and 9 of Annex I, a validity period of up to 7 years. The validity periods are to be decided on a case-by-case basis and may be reviewed. RoHS 2 exemptions maximum validity periods are listed in the table below. If any company cannot replace the hazardous substances, they can apply for an extension. The European Commission will evaluate the information to determine whether the exemption may be postponed or cancelled.
| Exemptions EEE categories | Exemptions listed in Annex III as at 21 July 2011 | Exemptions listed in Annex III as at 21 July 2011 |
| Categories 1 to 7 and 10 | 22 July 2011 – 21 July 2016 | Not applicable |
| Categories 8 and 9 general | 22 July 2014 – 21 July2021 | 22 July 2014 – 21 July 2021 |
| Category 8 in vitro* | 22 July 2016 – 21 July 2023 | 22 July 2016 – 21 July 2023 |
| Category 9 industrial* | 22 July 2017 – 21 July 2024 | 22 July 2017 – 21 July 2024 |
RoHS Exemption
Materials and components for specific applications shall be included in Annexes III and IV, provided that their elimination or substitution is scientifically or technically impracticable or, the reliability of substitutes is not ensured, or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits.
CTI’s Suggestion
The RoHS exemptions will be reviewed in accordance with scientific and technical progress. Manufacturers are recommended to update to the latest exemption list and look for new environmentally friendly substitutions, to make sure of the compliance of products for the EU market.