Medical Device Link.

REGULATION AND STANDARDS

Making the case

The current Directive on Restriction of Hazardous Substances (RoHS), 2002/95/EC, restricts placing on the market equipment containing six substances: cadmium, lead, mercury, hexavalent chromium, and polybrominated biphenyl- and polybrominated diphenyl-ether flame retardants. The European Commission and Directorate General (DG) Environment are reviewing the scope of the Directive and the current exemptions from its requirements.

The first stage of the review is an examination of categories 8 and 9 of the Directive relating to Equipment, which includes in vitro diagnostic (IVD) products. This work was conducted by ERA Technology, specifically Dr Goodman, Senior Materials Consultant, Reliability and Failure Analysis (www.era.co.uk), for DG Environment and the final report was issued in September 2006.¹

The European Diagnostic Manufacturers Association (EDMA), representing IVD manufacturers in the European Union (EU), presented a written submission and had a series of discussions with Dr Goodman. Details were presented on

• how these hazardous substances are used in IVD products
• the issues associated with their withdrawal and/or substitution
• the need for the continued exemption of IVD products from RoHS regulation
• information on the special features associated with IVD products.

Information gathered from EDMA members served to emphasise the main features of IVD products in this context including the

• long lifetime for each design
• close linkage between reagents and equipment
• use of tried and tested technologies
• length and complexity of the design process.

Report recommendations

An early message from the review was that the continued blanket exclusion of medical devices from the scope of RoHS was possible, but not likely, and EDMA insisted on the fact that specific exemptions would be required. During the review process, EDMA was able to present and discuss those features/exemption requests with Dr Goodman and this is reflected in the content of the final report, including the specific recommendations.

The final report notes that categories 8 and 9, Equipment, could be included in the scope of the RoHS Directive and describes the advantages and disadvantages of the inclusion or exclusion of these categories. With regard to continued exclusion, an advantage cited in the report is that because quantities are small in categories 8 and 9, there would be a small impact on the environment. A cited disadvantage, is the introduction in countries outside the EU such as China and Japan of RoHS type legislation, meaning a manufacturer would have to comply in any case. Regarding IVD products, the implementation date for new products is recommended to be 2016 (as opposed to 2012 for medical devices). The report also recommends that certain materials and usages are exempted, including sensors, detectors and electrodes, lifetime buy components and the temporary exclusion of leaded solder.

The initial response by EDMA’s experts in the industry is that the report captures the issues and concerns of the industry. It is acknowledged that the request by industry for continued exclusion of IVD products has been considered, yet the report finds that it is possible to include categories 8 and 9 within the scope of the Directive. Furthermore, the industry is already witnessing a move to exclude these substances as the components sector of the electronics industry, notably the printed circuit board (PCB) producers, make changes to accommodate Directive 2002/95/EC in its current scope, including the move to lead free solder for PCBs. These changes are also taking place because of the industry’s desire to be environmentally friendly.

Next stage

The expected timetable for the European Commission is that it will develop, together with the industry, an impact assessment based on the report during the next six months, prior to making a proposal for changes to the RoHS Directive in early 2007. There will be a possible impact on medical device manufacturers from 2010 to 2012 and from 2016 for IVD product manufacturers.

Karen Howes is Director of Regulatory Affairs at the European Diagnostic Manufacturers Association (EDMA), 2 Place des Maïeur, B-150 Brussels, Belgium, tel. +32 2 777 0274, e-mail: k.howes@edma-ivd.be, www.edma-ivd.be

EDMA is the trade association that represents the In Vitro Diagnostic (IVD) industry active in Europe. EDMA membership brings together 20 national associations in European countries and 17 of the major companies engaged in research, development, manufacture or distribution of IVD products in Europe. Through its affiliated national associations, EDMA represents in total more than 550 companies (or more than 1000 legal entities) across Europe.