Authors: Christel Brion, Florence Verhoestraete, Jeroen Boelens en Vincent Wellens (NautaDutilh) Publication date: 19/02/2019 Until recently, certain medical devices could only be distributed in Belgium through limited channels (pharmacies or dental practitioners). In addition, Belgian law prohibited the sale of some medical devices directly to physicians; consequently, patients could obtain such devices only from…
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Software may be considered medical device – Court of Justice (7 December 2017)
Software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of those provisions, even if that software does not…
Does your clinical trial pass the GDPR test? (Loyens & Loeff)
Author: Stéphanie De Smedt (Loyens & Loeff) Date of publication: 12/10/2018 Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating the processing of health data, international data transfers and contractual arrangements between the parties involved in a clinical trial, the GDPR has had…
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103...
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Software, of which at least one of the functions makes it possible to use patient-specific data...
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