Dynamic changes in Environmental Protection Directive
The European Environmental Protection Directive RoHS II (2011/65/EU) will also apply to Medical Devices and in-vitro diagnostics from July 22, 2014 and 2016 respectively. The Directive restricts the use of certain hazardous substances such as lead, mercury, or toxic flame retardants in electrical and electronic equipment. In Germany, RoHS II was transposed into national law in the German “Elektro-Stoff-Verordnung″ of May 9, 2013.
In the future, medical electrical equipment and in-vitro diagnostics may contain only limited quantities of certain substances that are likely to pose risks to health or the environment during use or disposal. The products and substances concerned are defined in Annexes I and II of the RoHS II Directive. The substance restrictions under the RoHS II Directive do not refer to a Medical Device as a whole but to each individual homogeneous material of its components. According to the definition in the RoHS II Directive, this means a material of uniform composition throughout or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes. Under this definition even a simple cable comprises two materials, i.e. a plastic jacket and a copper conductor.
RoHS II involves significant additional efforts in terms of technical documentation for the manufacturers of Medical Devices. Published in September 2012, the EN 50581 standard offers assistance in this area. In addition to instructions for use and product descriptions, manufacturers will have to provide exploded view drawings with numbered components and materials, a bill of materials, an assessment of material and supplier risk, and an RoHS II assessment for each individual material. As RoHS II has now been adjusted to the new legislative framework, the formal requirements for the EU declaration of conformity and CE marking must now also be fulfilled. Medical Device manufacturers can choose whether they want to issue a separate declaration of conformity for the MDD (93/42/EEC) and RoHS II (2011/65/EU) or a combined declaration that covers both Directives.
Manufacturers that opt for a combined declaration must add a disclaimer in which they expressly state that they have sole responsibility for conformity with RoHS II. The EU declaration of conformity and the technical documentation must be retained and readily retrievable for a period of ten years after the Medical Device has been placed on the market. By affixing the CE marking to their products, Medical Device manufacturers confirm that their products are in conformity with all applicable directives, including RoHS II.
Exemptions and amendments
If substitution is not possible for scientific or technical reasons, the EU grants exemptions from the substitution requirements in Annexes III and IV to the Directive. This includes materials such as lead in shielding for ionising radiation or in solders on circuit boards of portable Medical Devices. Manufacturers can also apply for further justified exemptions. Exemptions are temporary. Annexes III and IV are continuously reviewed and updated to the state of the art. In January 2014, for example, a total of 16 amendments were published, one of them concerning Annex III (general exemptions; 2014/14/EU as regards the mercury content of single capped (compact) fluorescence lamps) and 15 of them related to Annex IV (for Medical Devices and monitoring and control instruments; 2014/1/EU to 2014/16/EU). The EU announced another revision of Annex II (substances) to take place on July 22, 2014.