Final preparations for RoHS on medical devices + monitoring & control instruments
The clock is ticking! Most medical devices (category 8) and monitoring and control instruments (category 9) are required to meet the EU RoHS 2 Directive (2011/65/EU) requirements starting this July. The 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
Many category 8 and 9 manufacturers have put significant effort into RoHS compliance over the past several years. However, there are still a number of North American OEMs that started their RoHS compliance program more recently. In some cases, the rationale for the delayed start is that the products are not currently being sold into the EU. In other cases, a manufacturer may have had business priorities and is now trying to quickly implement a RoHS program. In these situations, a very focused and risk-based approach is needed.
The RoHS 2 Directive introduced mandatory requirements for conformity assessment procedures and other manufacturer obligations such as the technical documentation. Importers and distributors are required to ensure that their upstream partners have met their obligations and all three actors are legally required to immediately notify authorities and to take corrective actions if they have a reason to believe that a product may be non-conforming.
Substance restrictions and design conversion
Converting a product to RoHS compliant in a short timeframe is a significant challenge and poses business risks. Although many generic electronic components migrated to RoHS compliant in 2006, manufacturers generally still need to expend significant effort in confirming/converting other parts and assemblies.
Mechanical parts, special electrical components (such as sensors) and custom parts are often problematic. Contract manufacturers and suppliers that are focused on the category 8/9 , aerospace, and military industries may not be as familiar with RoHS substances in common materials. A not uncommon situation is an engineering drawing that includes a general statement of RoHS compliance, but then specifies a non-compliant part or material in the drawing. For example, many non-conforming metal alloys or plastic materials have been used. Although exemptions exist for lead in steel, copper, and aluminum alloys, some common alloys use more lead than allowed by the exemptions. In most contractual arrangements, the design authority is generally responsible for conformity and documentation of the bill of materials and the supplier or contract manufacturer may not catch these issues.
Even with commodity electronic parts, manufacturers should verify whether the components are using any exceptions that have either (1) expired or (2) are only allowed for certain applications.
To confirm/convert in a short timeframe requires a risk-based approach employing experienced engineering judgement to triage non-conformance risks.
Technical documentation file
The technical documentation required for RoHS 2 is 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. The EU harmonized standard for technical documentation specifies three possible types of conformity documentation for including in the technical documentation file: supplier certificates of conformity (CoC), material declarations, and analytical test reports. The harmonized standard also specifies that the conformity documentation must be assessed for reliability.
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.
In the case of class III medical devices, for which manufacturers submit documentation to Notified Bodies, the prevailing industry opinion is that the assessment does not need to include the RoHS technical documentation; however, the manufacturer should address this in their EU Declaration of Conformity (DoC) to avoid misinterpretation by customers and authorities.