RoHS is On Deck for Medical devices and Monitoring and Control Instruments

The clock is ticking! Most medical devices (category 8) and monitoring and control instruments (category 9) will come under the EU RoHS Directive (2011/65/EU) compliance requirements in three months’ time. The specific compliance dates for category 8 and 9 products are:

  • July 22, 2014 – Medical devices and monitoring and control instruments
  •  July 22, 2016 – In-Vitro diagnostic medical devices
  • July 22, 2017 – Industrial monitoring and control instruments

RoHS compliance has been a significant challenge especially for the category 8 and 9 product manufacturers. Use of small market suppliers and materials/part selection that did not consider RoHS restrictions in the original product design add to the challenge, especially for custom parts. For example, many non-conforming metal alloys or plastic materials have been commonly used by mechanical design engineers. It’s similarly common for a supplier to procure such materials, especially in North America or Asia if they are not otherwise provided specific instructions.

The technical documentation requirement of RoHS 2 is also non-trivial. The documentation must be sufficiently complete to allow an enforcement authority to assess the conformity of the product to RoHS substance restrictions. To avoid having to redo conformity assessment work, the technical documentation should be considered simultaneously with the design/re-design of the product.

Substance Restrictions and Design Conversion

The substance restrictions, at least for the time being, include the four heavy metals Lead, Mercury, Cadmium, and Hexavalent Chromium and the flame retardants Polybrominated biphenyl (PBB) and Polybrominated diphenyl ethers (PBDE). These are the same substances that were restricted under the original RoHS Directive.

Although many generic electronic components migrated to RoHS compliant in 2006, category 8 and category 9 equipment manufacturers generally still need to expend significant effort in converting other parts and assemblies. Even with commodity parts, manufacturers should be aware of parts with exemptions that will be expiring in the near future. Exemptions typically expire a few years later for category 8 and 9 products; however, material and technology changes being made by suppliers may impact the parasitics of certain components which are often utilized by test and measurement products. This has been a key concern expressed by some test and measurement equipment manufacturers.

Manufacturer obligations

The RoHS 2 Directive introduced mandatory requirements for conformity assessment and other specific obligations for manufacturers, importers, and distributors. A summary of the manufacturer obligations is provided below; for the exact wording, please refer to Article 7 of the Directive:

  • draw up the required technical documentation and carry out the internal production control procedure;
  • ensure that their products have been designed and manufactured in accordance with the requirements for substance restrictions;
  • ensure that procedures are in place for series production to remain in conformity;
  • take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation and with the requirements of the RoHS Directive;
  • EU declaration of conformity
  •  register of non-conforming EEE and product recalls, and keep distributors informed;
  • ensure that their EEE bears a type, batch or serial number or other element allowing its identification;
  • materials, components and EEE which have been tested or measured in accordance with harmonized standards demonstrating compliance, shall be presumed to comply with the requirements of the RoHS Directive;

RoHS Exemptions for Category 8 and 9 Products

In anticipation of category 8 and 9 products coming into scope of the RoHS2 Directive, manufacturers and industry associations have been requesting additional RoHS exemptions that are needed.

On January 9, 2014, the EU updated the RoHS 2 Annex IV list of substance exemptions with 14 new exemptions and a modification of exemption 12. The Annex IV exemptions are applicable only to Category 8 and 9 products. A complete list of the exemptions is available on our blog.

CE Marking for medical devices

The CE marking applied to products to indicate compliance with the Medical Devices Directive also meets the requirements of the RoHS Directive — only the single CE marking should be applied. However the manufacturer’s EU Declaration of Conformity needs to be updated to include attestation to the RoHS Directive.

Manufacturers of class III medical devices who submit documentation to Notified Bodies are not required to submit the RoHS technical documentation; however, they should address this in their EU Declaration of Conformity (DoC) to avoid misinterpretation by customers and authorities.

Aside from the Notified Body assessment described above, some manufacturers (medical devices and other products) will contract a certification body to assess against all CE marking requirements for the product. For these assessments, the RoHS technical documentation and other RoHS requirements should be assessed; however, not all certification bodies are performing a proper RoHS review. Manufacturers should be clear with the certification body on the level of due diligence that is being performed so that they can assess their risk exposure.