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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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…
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…
If a branded medicine and its generic version are put on the EEA market by economically-linked...
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are...
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced...
La Cour de Cassation a, dans un arrêt du 5 septembre 2019, cassé un arrêt de...
Le 14 mai 2019, une nouvelle loi a été publiée au Moniteur belge relative à la...
On 23 January 2019, the European Data Protection Board (EDPB) issued its Opinion 3/2019 on the...
On 7 February 2019, the federal government submitted a bill regarding the reimbursement of pharmaceutical specialties...
Until recently, certain medical devices could only be distributed in Belgium through limited channels (pharmacies or...
Le schéma de médication en pratique Il faut d’abord distinguer le schéma de médication de la...
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that...
On 25 October 2018, the CJEU ruled in Case C-413/17 on the margin of discretion of...
Dans un blog de juillet dernier, nous commentions la loi du 19 juillet 2018 relative au...
Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating...
A partir du 24 juin 2018 une distinction claire est opérée entre le secret professionnel et...
Software, of which at least one of the functions makes it possible to use patient-specific data...
The discovery of Fipronil residue in chicken eggs due to the use of Fipronil as an...
Recentelijk kon via de media vernomen worden dat het ziekenhuis Oost-Limburg geconfronteerd wordt met een belastingclaim...
La Cour de cassation a rendu un arrêt le 22 juin 2017, suite à un pourvoi...
The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on...
From 19 October 2017, use of the electronic Trade Control and Expert System (“TRACES”) will become...
