NSF Health Sciences has released a free white paper which describes the requirement for a "Qualified Person" (QP) contained in the EU Commission Proposal for a new regulation to cover medical devices and active implantable medical devices.
The proposal is the result of long discussions between the Commission and stakeholders in the 27 Member States and aims to address the perceived weaknesses of the current Directives 93/42/EEC and 90/385/EEC.
Click here for more information and to download the white paper.