The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:

The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU.  You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.

As an overview:

–   Scope:

    • Medical devices (per 93/42/EEC) and IVD devices (per 90/385/EEC) are now included.  They are both part of the general group called “medical devices” in the directive.
    • Active implantable medical devices remain excluded from the requirements of the directive.

–   Limits: The maximum concentrations in homogenous materials are limited, by weight:

    • Lead (0.1 %)
    • Mercury (0.1 %)
    • Cadmium (0.01 %)
    • Hexavalent chromium (0.1 %)
    • Polybrominated biphenyls (PBB) (0.1 %)
    • Polybrominated diphenyl ethers (PBDE) (0.1 %)

–   Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from

    • 22 July 2014 for Medical Devices.
    • 22 July 2016 for In-Vitro Diagnostic Medical Devices.

NOTE:  A single CE mark and declaration are acceptable.  (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

–   Exemptions:

    • Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
    • Exemptions available to all devices are listed in Annex III.  Specific exemptions for medical devices are listed in Annex IV.
    • Exemptions for medical devices will be valid for up to 7 years.
    • Requests for exemptions:
      • Will be filed with the Commission and include all information listed in Annex V.  Most notably, the request must include an analysis of possible alternative substances, materials or designs.
      • Renewals must be requested at least 18 months before the existing exemption expires.
      • Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health and consumer safety impacts.

–   Labeling: The labeling requirements are likely already addressed by MDD or IVDD requirements.  However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.

–   Record Retention:

    • Records must be retained for 10 years after a device is placed on the market.  Note that this may be longer than required by the MDD or IVDD.
    • Records to retain include:
      • Technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,
      • List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and
      • List of  any economic operator to whom you have supplied any electrical or electronic equipment.

If you would like to see some additional information on some of the areas, in the future, that may be implemented refer to the  BSI article that is posted on our website.

Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition.  Please feel free to contact me, Leo Eisner () if you have any questions on this subject and I would be more than happy to assist you.

Please contact us if you have questions or concerns.

RoHS Recast Implications to EU Med & IVD Devices
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