Dutch Reply to Dalli Acton Plan Offers Clues to How MDD Recast May Shape Up

A Dutch proposal to tighten device vigilance in the EU would intensify inspections of devicemakers that operate internationally and organize surveillance around the complete life cycle of specific product lines. Manufacturers that operate internationally should be assessed by joint audit teams composed of inspectors from the competent authorities of at least two EU member states, according to an April 5 letter from Dutch Minister of Health, Welfare and Sport Edith Schippers to John Dalli, EU commissioner for health and consumer policy.
International Medical Device Regulatory Monitor