In addition to the Chemicals Regulation REACH (Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemical substances), medical devices will soon have to comply with the European RoHS (Restriction of Hazardous Substances) Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
This affects US exports to the EU, the EFTA countries (Iceland, Liechtenstein, Norway), Switzerland, and Turkey. The current scope of products will expand until the use of the RoHs 6 hazardous substances: lead, mercury, cadmium, hexavalent chromium, and the flame retardants PBB and PBDE, will be essentially banned in all electrical and electronic equipment (EEE) up to 1,000 Volts AC, 1,500 volts DC sold in the EU.
In 2011, the European Union issued Directive 2011/65/EU on the restriction of the use of certain hazardous substances in all electrical and electronic equipment. The new directive updates and supercedes RoHS, and has come to be known as the RoHS Recast or RoHS 2.
As of July 22, 2014, the provisions of RoHS 2 will apply to Category 8, medical devices, and Category 9, monitoring and control instruments. Category 11, all other EEE not covered by any other category, will come into scope by 2019. Cables, spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity for a specific product category, must comply from the same date as their respective product category. Furthermore, all products with a CE marking must also be RoHS-compliant. Technical documentation and the compulsory EU declaration of conformity for proof of compliance must be prepared for every product and archived for ten years.
The exemptions policy was also changed. Industry, instead of the EU government, will now have to prove the necessity of an exemption. Exemptions also have expiration dates and companies will need to submit a renewal application at least 18 months before the exemption expires in order to the EU to consider renewing the exemption. The revised RoHS Directive is a CE Marking Directive, which will require manufacturers, distributors and importers to accurately label EEE manufactured or sold in the EU.
The Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)was published in the Official Journal of the European Union, and can be read here: