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ISO 13485 (ISO/TC 210)
(June 11, 2015) It is expected that the Final DIS (FDIS.2) of the ISO 13485:201x will be approved during the ISO/TC 210 WG1 meeting scheduled in November 14-20, 2015 (Denver, US). So, final publication of the medical device ISO 13485 scheme will be properly somewhere in Q1/2016. There’s good and…
Medical Device Regulations - Update
On the 19th of June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernizing EU rules on medical devices and in vitro diagnostic medical devices. This is a step towards providing the presidency with a mandate to start talks with the European…
Changing role of notified bodies in the process to obtain CE mark
(June 10, 2015) Our analysis of recent published survey - which was initiated by the European Association Medical Device Notified Bodies (TEAM NB) - identified continuous trends towards of: increasing number of certificates being withdrawn; decreasing number of new conformity certificates issued; and increasing number of staff (fte's). A more…
Verwachting: In vitro diagnostica wordt goedgekeurd
Naar verwachting zal tijdens de Luxemburgse voorzitterschap de nieuwe Europese regelgeving op medische hulpmiddelen en in vitro diagnostica goedgekeurd gaan worden (MDR en de IVDR). Wellicht zal dan ergens in november 2015 deze EU voorstellen gepubliceerd gaan worden, waarbij dan tevens de overgangsperiode van maximaal drie jaar in zal gaan.…