The Eucomed Electronic Devices Working Group has published a guidance document to clarify conformity assessment requirements for manufacturers of medical devices that fall within the scope of the recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU (RoHS 2). Like the medical device directives, RoHS 2 is a CE marking directive, and there is some overlap in the conformity assessment procedures, which the guidance explains. It also addresses the role of the Notified Body in relation to conformity assessment of devices that must comply with RoHS 2.
In essence, the paper clarifies the following points:
- Notified Body audits under the medical device directives should not include a review of technical or quality system documents and procedures related to RoHS 2 conformity. This is the responsibility of member states.
- Under the medical device directives, a Notified Body reviewing technical documentation of a manufacturer with a Declaration of Conformity showing compliance to several EU acts should limit the scope of its conformity assessment activities to those requirements for which its involvement is required.
The guidance document, “Delineation between the Conformity Assessment requirements of the Medical Devices and the RoHS 2 Directives,” can be downloaded free of charge from the Eucomed website.