In a judgment of 20 September 2010 the The Hague District Court ruled that it was OK for AED that are CE marked to not be accompanied by paper instructions for use but rather by means of a CD-ROM that contains a URL that refers to the OEM’s Dutch language instructions for use on the website of the US based OEM.

This means that the court – probably without realizing it – ruled that e-labelling is now permitted, if the reasoning in the judgment is followed. Translated literally the court finds that ‘any argument why the provision [of instructions for use] should be limited to provision in paper form only has not been put forward, as a consequence of which this position must be rejected’ (point 4.18 of the judgment).

As far as I am aware the parties have not appealed the judgment. The Dutch authorities that I spoke to about this subject were surprised about the judgment and said it was against the law as they interpret it.

I will publish an extensive annotation of this judgment in the next issue (2010 nr 4) of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht.

 

Labeling

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08/11/2010

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