(Originally posted March 5, 2014 & updated March 6, 2014) The changes made to these 16 Delegated Directives to the RoHS 2 Directive (2011/65/EU) add more exemptions to Annex IV of the Directive. Annex IV is for the “Applications exempted from the restrictions in Article 4(a) specific to medical devices and monitoring and control instruments”. Most of these exemptions are for medical devices and some have an expiration date and others don’t have an expiration date, at this time.
COCIR (a European medical device trade organization) requested twelve RoHS2 exemptions between September 2011 and March 2012 for Annex IV and all of them were granted as they are all noted in the below listing of 16 exemptions that were granted. COCIR produced a really helpful resource guide on the RoHS 2 Directive and if you would like to see the original exemptions list that COCIR requested go to section 8 of the document.
The exemptions that were added without an exemption date could be changed in the future so you should keep an eye out for changes to the exemptions list in Annex IV of the RoHS 2 Directive. Also, the Directive could have changes elsewhere such as the list of materials that are banned, most definitely will expand over time, in Annex II, among other changes. The best place to check for these changes is at the Europa Website for the RoHS 2 Directive under the heading RoHS 2 and then go down one more heading to Secondary Legislation on RoHS 2 which then has a sub-heading of Exemptions which currently has 3 listing in this section. One for the Commission Delegated Directive 2012/50/EU (the 1st added exemption), for the Commission Delegated Directive 2012/51/EU (the 2nd added exemption), and lastly the 16 Commission Delegated Directives 2014/1/EU to 2014/16/EU which is what the rest of this post is all about. See the below for the 16 Delegated Directives and links to each one of them. A description of each exemption is noted in the below listings for your ease of use here.
Walter Jager, of ECD Compliance, provided some clarification about exemptions without an exemption date. He advised me the following:
“It’s also important to note that the RoHS 2 Annex IV exemptions that have no expiry date are valid for up to 7 years. For example, for most category 8 medical devices (ie. the medical devices that must be RoHS compliant by July 22, 2014) these Annex IV exemptions will automatically expire on 22 July 2021 . A manufacturer or industry association may apply to extend the exemption if there is still justification, but the application needs to be made at least 18 months before the expiry date. For category 8 in-vitro devices the default expiry is 22 July 2023 (22 July 2024 for category 9 industrial monitoring and control equipment). The recent Annex IV exemptions generally have fixed expiry dates.”
Commision Delegated Directive 2014/1/EU amending…Directive 2011/65/EU
Commision Delegated Directive 2014/2/EU amending…Directive 2011/65/EU
Commision Delegated Directive 2014/3/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/4/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/5/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/6/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/7/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/8/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/9/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/10/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/11/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/12/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/13/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/14/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/15/EU amending…Directive 2011/65/EU
Commission Delegated Directive 2014/16/EU amending…Directive 2011/65/EU