Does the NEW RoHS 2011/65/EC Directive Apply to Medical Devices?

The recast of the Restriction of Hazardous Substances (RoHS) Directive was published in the official journal of the European Commission on the 8th of June 2011 as 2011/65/EU.

With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.

Scope:

Medical devices (under 93/42/EEC) and IVD devices (per 98/79/EC) are now included.  They are both part of the general group called ‘medical devices’ in the directive. Active implantable medical devices (under AIMDD 90/385/EEC) remain excluded from the scope of the 2011/65/EU.

Limits: 

The maximum concentrations in homogenous materials are limited, by weight, to the following:

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 marking and have a declaration of conformity for the RoHS Directive from:

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

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

Authorized Representative:

  • Means any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks (RoHS 2011/65/EU Article 2.7);
  • A Non-EU manufacturer (not having a registered address in the EU) will be required to nominate an Authorized Representative in order to obtain the CE marking.

 

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:
  • Must 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.

 

Labeling:

The labeling requirements are likely to have been already addressed by MDD or IVDD requirements.  However, a review of the requirements in Articles 7.g, 7.h9.d and 10.a will be needed for confirmation.

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 93/42/EEC or IVDD 98/79/EC.
  • Records to retain include technical documentation confirming compliance with the RoHS Directive and a register of non-conforming products and product recalls.

 

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in Industry News Active Implantable Medical Devices, Industry News Medical Devices, Medical Device Compliance - FAQs, News