The main summary amendments adopted in plenary were as follows:
Scope:Parliament called for devices for aesthetic purposes to fall within the scope of the regulation.
Furthermore, the Regulation should not impede the continued application of measures within Directive 2002/98/EC and its five Daughter Directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.
Our Simple Business Approach - is to provide RREE guidance and templates to help businesses achieve a clearer understanding of the regulatory requirements and the necessary compliance.
Our Authorised Representative, EU Responsible Person, Permanent EU Office and Notional Importer Services can be established quickly. A leader in the difficult area of Borderline Drug - Medical Devices, our Technical Specialists are also employed by Notified Bodies, which ensures our high level of successful CE Marking of Class III Design Dossiers.