Dutch medical devices law due in February 1995:
This article was originally published in Clinica
Executive Summary
The Dutch medical devices law, transposing the EU's Medical Devices Directive, is now expected to be published in mid- February. Technical hitches have caused a slight delay. The Health Ministry has confirmed that KEMA, based in Arnhem, has been designated a Notified Body for all conformity assessment procedures with regard to all devices covered by the Medical Devices Directive, while TNO-Certification, based in Apeldoorn, has been designated for all with the exception of Annexes 3 and 4 for: radiotherapy equipment; MRI equipment; surgical lasers; intraocular lenses; and contact lenses and accessories.