08 May 2019 - Authored by:Alex Crespo van de Kooij
The Dutch Health Minister has introduced a Decision setting out a policy rule on the interpretation of the definition of medical device (medisch hulpmiddel), as laid down in the Act on medical devices (Article 1, first paragraph, under a). The Decision was published on 4 April 2019 and entered into effect on the same date.
The Decision requires the Minister to take into account measures taken by the European Commission in accordance with Article 13 of the Medical Devices Directive (93/42/EEC) when interpreting the definition of medical devices. Article 13 provides that EU member states may request that the Commission decide whether a certain product qualifies as a medical device. As member states are bound by the Commission’s decisions, the Minister has decided that they must be taken into account when interpreting the definition laid down in the Act on medical devices.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, April 2019 Issue (Thomson Reuters).