Reutlingen, February 27, 2013 – In addition to the Chemicals Regulation REACH (Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals), medical devices will have to comply with the European RoHS Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment in the future: As of July 22, 2014, RoHS (Restriction of Hazardous Substances Directive) must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE marking must also be RoHS-compliant. This means considerably more work for manufacturers, suppliers and importers regarding the documentation and monitoring of medical devices – for instance, a continuous exchange of information in the entire supply chain is required.
With RoHS, the European Union wants to optimize the manufacturing and the respective recycling of the rapidly changing products in the electronics industry. The RoHS-Recast Directive (2011/65/EU), in force since 2011, now expressly includes medical devices. For example, a technical documentation and the compulsory EU declaration of conformity for proof of compliance must be prepared for every product and archived for ten years. “If the additional tasks are not supported by a professional and established software solution, there will be a significantly increased personnel expenditure in any case“, says Marek Stachura, product manager for electronics and medical technology at iPoint-systems, the world’s leading software and consulting partner for environmental product compliance and sustainability.
In case of suspected non-conformity, the competent authority will be informed. This can lead to corrective measures or returns and recall. Adaptive software solutions like iPoint’s Compliance Agent ensure that this does not happen: They are adjusted to the latest versions of the respective directives currently in force and ensure automated and secure exchange of relevant information across the entire supply chain.
Overview of banned substances:
Hexavalent chromium (0.1%)
Polybrominated biphenyls (PBB) (0.1%)
Polybrominated diphenyl ethers (PBDE) (0.1%)