German industry takes EU to task over dual standards requirements
This article was originally published in Clinica
Executive Summary
Manufacturers of devices that have moving parts or can be classified as "machines" under EU Directive 2006/42 will incur increased costs if provisions relating to standards in the five-year review of the MDD (93/42) remain in the text when it comes into force. The text will become official (but still needing transposition and enforcement) 20 days after OJ publication, which is expected around October.