Electrical vs. MDD Compliance Focus of Eucomed Guidance
Eucomed has released an industry guidance targeting devicemakers that must comply with a law on electrical products in addition to the medical device directive, starting in July 2014.
The guidance attempts to differentiate between conformity assessment requirements in RoHS 2 — the amended directive on restriction of hazardous substances in electrical and electronic equipment (2011/65/EU) — and those in the device directive (MDD 93/42/EEC). RoHS 2 requires manufacturers to submit technical documentation and a declaration of conformity and apply CE marks to finished products.
While there are similarities between the two directives, RoHS 2 does not mandate notified body assessment of compliance, as is the case with the device directive. Notified body audits for MDD compliance should exclude reviews of documents and processes pertaining to RoHS 2 conformity, Eucomed says. “Ensuring compliance to the RoHS 2 Directive remains the responsibility of the Member State.”
RoHS 2 permits devicemakers to combine technical documentation for electrical equipment and medical devices in a single file, but notified bodies should only review information that is relevant to the jurisdictions they serve, Eucomed advises. For example, they should not review quality system documents and procedures specifically related to RoHS 2 conformity.
Given that EU medical device legislation is still not final, separate declarations of conformity referring to the two sets of requirements are still possible, the group adds. “Nevertheless, in all cases when addressing compliance to RoHS, the Declaration of Conformity must contain a disclaimer stating that it is issued under the sole responsibility of the manufacturer underlining the manufacturer’s responsibility for compliance with the referenced Union Acts,” the guidance states.
“In the event that compliance with several Union Acts is declared in one Declaration of Conformity the name, address and identification number of the Notified Body involved per Act should be specifically declared,” the guidance adds.
While RoHS was always intended to include medical devices, Eucomed has expressed concern the restrictions could put European devicemakers at a competitive disadvantage in non-EU markets by forcing them to use more costly and unproven alternative materials. It also could create supply problems and development issues for some device manufacturers, industry says.
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