RoHS 2 Directive (2011/65/EU) Changes to Annex IV (Med Dvcs & Control/Monitoring Instruments) Exemptions Listing

(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 1^st added exemption), for the Commission Delegated Directive 2012/51/EU (the 2^nd 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

an exemption for lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation  

Commision Delegated Directive 2014/2/EU amending…Directive 2011/65/EU

an exemption for cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020

Commision Delegated Directive 2014/3/EU amending…Directive 2011/65/EU

an exemption for lead acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment

Commission Delegated Directive 2014/4/EU amending…Directive 2011/65/EU

an exemption for lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers 

Commission Delegated Directive 2014/5/EU amending…Directive 2011/65/EU

an exemption for lead in solders on printed circuit boards, termination coatings of electrical and electronic components and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers and sensors that are used durably at a temperature below – 20 °C under normal operating and storage conditions

Commission Delegated Directive 2014/6/EU amending…Directive 2011/65/EU

an exemption for lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions

Commission Delegated Directive 2014/7/EU amending…Directive 2011/65/EU

an exemption for lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used (a) in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or (b) in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy

 Commission Delegated Directive 2014/8/EU amending…Directive 2011/65/EU

an exemption for lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards

Commission Delegated Directive 2014/9/EU amending…Directive 2011/65/EU

an exemption for lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors

Commission Delegated Directive 2014/10/EU amending…Directive 2011/65/EU

an exemption for lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category  8) and/or in industrial monitoring and control instruments 

Commission Delegated Directive 2014/11/EU amending…Directive 2011/65/EU

an exemption for hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020 

Commission Delegated Directive 2014/12/EU amending…Directive 2011/65/EU

an exemption for lead in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment 

Commission Delegated Directive 2014/13/EU amending…Directive 2011/65/EU

an exemption for lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators

Commission Delegated Directive 2014/14/EU amending…Directive 2011/65/EU

an exemption for 3,5 mg mercury per lamp in single capped compact fluorescent lamps for general lighting purposes < 30 W with a lifetime equal to or above 20000 h

Commission Delegated Directive 2014/15/EU amending…Directive 2011/65/EU

an exemption for lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer

Commission Delegated Directive 2014/16/EU amending…Directive 2011/65/EU

an exemption for lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi₂O₅  Pb) phosphors