
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:
- Binding introduction of the EC type examination (in
accordance with Annex III of Directive 93/42/EEC) as an obligatory procedure
within conformity assessment.
- 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).
- 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.
- 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