This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011. We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU).
Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered for a recast; also other parts of EU legislation are being revised. One of these is the RoHS Directive that regulates hazardous substances in electrical and electronic equipment (EEE) in the EU. Work on the revision started in 2008 when it was called RoHS 2 (or RoHS II). By now the revision is ready and will be presented as “RoHS Recast,” because the existing directive will be repealed and replaced rather than simply amended.
Utilizing the EU’s New Approach and New Legislative Framework, the new directive will move specification of restricted substances and covered EEE to the Annexes so that they can be easily “adapted to technical progress” (ATP). The CE mark will be required for compliance; procedures for conformity assessment are specified; and standards developed by European Standards Organizations are utilized. The European Parliament adopted the “consolidated text” for RoHS Recast late 2010, and the final step to approve legislation in the Council of the European Union is very near.
The change will significantly impact the medical device field. Where currently all medical devices and IVDs are exempt from the directive, the automatic exclusion from RoHS will disappear for MDD and IVDD devices, while it remains in place for active implants under AIMDD. The new legislation has foreseen various transition times. Medical devices, as well as monitoring and control instruments, must comply within three years after publication in the EU Official Journal, whereas IVDs must comply within five years.
The six original RoHS substances (lead, mercury, cadmium, hexavalent chromium, PBB and PBDE as identified in RoHS Annex II) are still the only ones restricted, and no changes were made to their allowed concentrations. However, future additions to the list remain likely. The Environmental Committee report recommended that brominated flame retardants, chlorinated flame retardants, PVC, chlorinated plasticizers, DEHP, BBP, and DBP be restricted. The COR Committee opinion expressed regret that HBCDD, DEHP, BBP, and DBP were not included. Moreover, a full evaluation of the new Annex II, specifying the banned substances, is required in three years.
It is possible for individual manufacturers to apply for specific exemptions. (Specific procedures have been set up to grant the information; annex V or RoHS recast provides details.) A list of exemptions granted for 7 years exists. The application needs to be submitted before 2014, realizing that the renewal to exemptions has to be sent 18 months before the deadline.
If no exemption is successfully obtained, then to comply with the Directive the manufacturer will need to set up a self-declaration of conformity referring to the RoHS. In order to do so, manufacturers must maintain technical documentation, cite relevant harmonized standards, implement internal production controls, and keep a register of nonconforming products. CE mark is required on the finished product, as well as manufacturer’s name, trademark, contact address, and a type, batch or serial number (to facilitate recalls) should be present on the labelling. The EC Declaration of Conformity (specified in annex VI) that accompanies the finished product should be in the language of the local market. In the event that the product is manufactured outside the EU, then the EU importer who will share the responsibility for compliance with the manufacturer is also needed.
The EU Commission website to monitor for news of the recast of RoHS Directive is:http://ec.europa.eu/environment/waste/weee/index_en.htm
Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition. Please feel free to contact me, Leo Eisner () if you have any questions on this subject and I would be more than happy to assist you.