In May 2011, the European Union adopted new legislation concerning the Restriction of Hazardous Substances in Electrical and Electronic Equipment, RoHS 2 (2011/65/EU). This Directive replaces the previous RoHS Directive (2002/95/EC). Even though it doesn’t add new restricted substances, the Directive has a wider scope that impacts the documentation requirements and legal responsibilities of a larger number of businesses, from importers and distributors to manufacturers.
Additional Categories To Include Medical Devices
RoHS 2 was implemented into national legislations by 2 January 2013. The number of categories of products covered by RoHS 2 has increased to 11, due to the inclusion of three new categories comprising of medical devices, monitoring and control instruments, and all other electrical and electronic equipment not covered by any other category. Therefore, these categories include products which were initially excluded, such as Medical Devices and In Vitro Medical Devices.
The list of RoHS 2 restricted hazardous substances with their respective maximum allowable concentration in homogeneous materials includes: Lead (Pb, 0,1%), Mercury (Hg, 0,1%), Cadmium (Cd, 0,01%), Hexavalent Chromium (Cr VI, 0,1%), Polybrominated Biphenyls (PBB, 0,1%), and Polybrominated Diphenyl Ethers (PBDE, 0,1%).
Key Implications For Medical Devices
Some of the medical devices now affected by RoHS 2 requirements include X-ray equipment, magnetic resonance imaging (MRI) equipment, portable emergency defibrillators, and computerised tomography machines.
Medical devices, such as MRI equipment and computerised tomography machines will need to demonstrate compliance with RoHS requirements starting on 22 July 2014, while In Vitro Medical Devices such as polymerase chain reaction (PCR) equipment have more time until 22 July 2017. Active Implantable Medical Devices are not included in RoHS 2. Only spare parts specifically manufactured for the repair, the reuse, the updating of functionalities or upgrading of capacity, and already available on the market before the above-mentioned dates are exempt from compliance with RoHS 2.
In addition to the impact of this new product category, RoHS 2 brings about a few other significant changes related to the broader scope of the Directive which has implications on the legal responsibilities of businesses.
Some of these changes affect manufacturers directly, as they are required to:
- Issue a signed Declaration of Conformity (DoC)
- Create a Technical Documentation File per the EN 50581:2012 or equivalent that meets requirements of module A of Annex II to decision 768/2008/EC
- Accept analytical material test results per the IEC 62321 Standard
- Keep the DoC and Technical Documentation File for a period of 10 years after the product has been placed on the market
- Obtain the CE marking, to prove RoHS 2 compliance
Since the CE marking now has a double function, manufacturers are required to comply with RoHS requirements not only in their technical documentation, but also on the EU DoC. In other words, the CE marking cannot be applied to the product until RoHS 2 compliance is demonstrated. In addition, the technical documentation must include among other things a conformity assessment, the use of standards, supplier declaration(s) of compliance, materials declarations, and results of any supplier audits as well as possible test results.
Businesses that were not part of the scope of the original Directive will now be faced with considerable burdens in creating and gathering the required documentation. On the other hand, manufacturers that are already in compliance with RoHS are affected by the application of the CE marking, which might involve additional testing and documentation. And since RoHS 2 conformity is not a one-time task, companies could face non-compliance consequences.
SGS Medical Devices Services Can Help
Whatever the challenge, the SGS Medical Devices team is able to provide expert support for RoHS 2 compliance. As part of SGS – the world’s leading verification, testing and certification company – we specialise in partial and complete testing of finished products, and offer options for non-destructive testing.
Our RoHS related services for medical devices include:
- Energy Related Products (ErP)
- Full Product and Material Testing to IEC 62321 standards
- Process Gap Analysis and Consulting
- Product Risk Assessment
- REACH-Annex 17
- RoHS Certificate of Conformity
- Verification Services
- XRF Screening
To find out more about SGS RoHS2 services for medical devices, download our latest RoHS2 flyer on this topic.