The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
EUROPEAN COMMISSION REVISES BLUE GUIDE ON THE IMPLEMENTATION OF EU PRODUCT RULES
The revised Blue Guide, which was drafted in close cooperation with the EU Member State national authorities, provides a detailed explanation of the various elements of EU harmonisation measures concerning the products affected by these measures. EU harmonisation measures, such as Regulations and Directives, are designed to modernise the conditions for placing products on the EU market and provide a complete legal framework for these products.
EU harmonisation measures apply to products which are intended to be placed on the EU market and include industrial products and products intended for use by consumers or professionals. The Blue Guide does not discuss the applicable rules for food or agricultural products.
The Blue Guide discusses the application of the EU harmonisation measures, which includes the Active Implantable Medical Devices Directive, the Medical Devices Directive and the In vitro Diagnostic Medical Devices Directive.
The Blue Guide also examines the following elements of placing a product on the EU market:
- Obligations of economic operators in the supply chain. These obligations apply to the manufacturer, the authorised representative, the importer and the distributor of the product. The Blue Guide discusses the definition of "placing on the market" in this context.
- Essential Requirements. Essential Requirements may arise from certain hazards associated with the product or refer to its performance or lay down the principal protection objectives. The Blue Guide examines the role of harmonised standards, traceability requirements, EU Declarations of Conformity and CE marking in this Chapter on Essential Requirements.
- Conformity assessment. The Blue Guide discusses the structure of conformity assessments and the role and responsibilities of conformity assessment bodies and notified bodies.
- Accreditation of conformity assessment bodies. This includes information on the accreditation structures both at an EU level and internationally.
Appropriate market surveillance mechanisms. This is a new Chapter in the revised Blue Guide which provides guidance, including guidance on market surveillance activities, EU Member State responsibilities, and corrective measures such as recalls and sanctions. The Blue Guide also discusses the medical devices vigilance system.
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