Hazardous Substance Restrictions Affecting European Device Industry

European Union (EU) restrictions on the use of certain hazardous substances in electronic and electrical equipment could put European devicemakers at a competitive disadvantage in non-EU markets by forcing them to use more costly and unproven alternative materials, several industry trade groups told the European Commission (EC) in comments.

The EC initiated a review of the Restriction on Hazardous Substance (RoHS) Directive 2002/95-EC in 2005 to consider when and how to include Category 8 and 9 products — medical devices and monitoring and control equipment, respectively — within its scope.

Although medical devices are currently exempt from the RoHS directive, the restrictions on substances such as lead, mercury and cadmium are nonetheless creating supply problems and development issues for some device firms, according to comments filed by Eucomed, the European Diagnostic Manufacturers Association and the European Coordination Committee for the Radiological, Electromedical and Healthcare IT Industry.

For example, the groups said “some larger manufacturers (primarily of low-risk medical devices) are exploring lead-free manufacturing because they do not wish to run two different production lines and they are having increasing difficulty obtaining non-RoHS-compliant components.”

Other problems include difficulty finding replacement parts, which is rendering some devices prematurely obsolete, the groups said, noting that low-volume parts may not be converted to compliant versions. The result is that R&D dollars are being diverted from next-generation products, delaying access to new technologies, the groups said.