Med-Info - A guide to MDD revisions
TÜV Product Service has published an information bulletin to provide advance information on the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMD).
The new directives were adopted by European Parliament on March 29, 2007 and are now being transposed, by each Member State, into national law.
Within this information bulletin, entitled 'MDD Revised – a survey of the essential modifications' senior medical device auditors from TÜV Product Service explain the implications of the proposed changes, highlighting the impact on conformity assessment procedures for medical devices. They also give details of the new requirements regarding design and construction and explain how the role of Notified Bodies has been strengthened by this new legislation.
