Eurolab News Article
       EU Policies 02/05/2012
 
CEOC International, EUROLAB and IFIA call for improvements to the European medical devices approval system

 Current events made the modernisation of the medical device directives the centre of political discussion. CEOC International,

EUROLAB and IFIA have joined their forces and call for improvements to the current medical devices approval system in Europe in their common position paper On Safe Medical Devices for Europe.

 

CEOC International, EUROLAB and IFIA, representing the main organisations in the testing, inspection and certification sector, propose the following improvements to the approval system with regard to Class III products: 

  1. Binding introduction of the EC type examination (in accordance with Annex III of Directive 93/42/EEC) as an obligatory procedure within conformity assessment.
  2. Introduction and establishment in law of obligatory, unannounced factory inspections by notified bodies and specified sampling of products within the manufacturing process (at the assembly line).
  3. Introduction and establishment in law of obligatory sampling and testing of products already on the market following clear and universally-applicable rules (Following ISO/IEC Guide 67 - Conformity assessment; Fundamentals of product certification, Table 1, System 5 from the year 2004) as an extension of the conformity assessment procedure.
  4. Notified bodies should be included in the information flow of the market surveillance authorities in the case of medical devices.

To read the full position paper please follow this link: Safe Medical Devices for Europe