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The new RoHS2 Directive, Restriction of Hazardous Substances in Electrical and Electronic Equipment, RoHS 2 (2011/65/EU), adopted by the European Union in May 2011 is meant to replace RoHS Directive (2002/95/EC). The new Directive makes no mention of new restricted substances, but has, however, a broader scope, which affects the compliance documentation prerequisites for many businesses.

NEW MEDICAL DEVICES PRODUCT CATEGORIES

Some of the new products include monitoring and control instruments and other electrical and electronic equipment not part of any other category. Although previously omitted, Medical Devices and In Vitro Medical Devices are now also covered by the Directive. RoHS 2 also itemizes the restricted hazardous substances and the maximum allowable concentration in homogenous materials as follows: 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%).

HOW ARE MEDICAL DEVICES AFFECTED?

RoHS 2 compliance specifications now concern other medical devices such as magnetic resonance imaging (MRI) equipment, computerised tomography machines, and X-ray equipment. The 22nd of July 2014 is the deadline for MRI equipment and computerized tomography machines to show compliance with RoHS regulations, whereas In Vitro Medical Devices such as polymerase chain reaction (PCR) equipment have an extended compliance time frame, until the 22nd of July 2017. Active Implantable Medical Devices are not covered by RoHS 2, and spare parts that are already on the market before the deadlines mentioned earlier are excluded from compliance with the Directive.

WHAT ARE THE OBLIGATIONS OF MANUFACTURERS?

The new Directive includes a few updates to the legal requirements that have a direct impact on manufacturers’ responsibilities, requiring them to:

  • Release a signed Declaration of Conformity (DoC)
  • Produce a Technical Documentation File as 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
  • Retain the DoC and Technical Documentation File for a period of 10 years after the product has been placed on the market
  • Get the CE marking, to demonstrate RoHS 2 compliance

The CE marking now plays a dual role.  It means that manufacturers are obliged to prove compliance with RoHS requirements not only as part of the technical documentation, but also on the EU DoC. Consequently the CE marking cannot be applied until the manufacturer is able to demonstrate RoHS 2 compliance.

Furthermore, a conformity assessment, results of any supplier audits / possible test results, the use of standards, and supplier declarations of compliance must also be provided along with the technical documentation. This is why businesses that were not affected by the scope of the original Directive will now have the challenging responsibility of developing and collecting all the necessary documentation and avoid the risk of facing non-compliance penalties. The new Directive and the dual role of the CE marking also impacts manufacturers that are already compliant with RoHS, as this could involve further testing and documentation.

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:

  • Full Product and Material Testing to IEC 62321 standards
  • Process Gap Analysis and Consulting
  • Product Risk Assessment
  • REACH-Annex 17
  • RoHS Certificate of Conformity
  • REACH-SVHC

Find more information about SGS services for medical devices or contact:

Seppo Vahasalo
Medical Devices
Product Line Manager
SGS Fimko Ltd
t +358 40 560 9500

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.