Berichten getagd ‘medical device’
Medical apps & traps: nieuwe verstrengde en verruimde regelgeving voor medische softwareleveranciers (Monard Law)
Auteur: Monard Law Het gebruik van medische apps (als medisch hulpmiddel) is niet meer weg te denken uit ons dagelijks leven, denk maar aan hartmonitoringsystemen, glucosemeters, elektronische thermometers, stethoscopen,… Medische apps veranderen ons klassieke gezondheidszorgsysteem en leiden niet alleen tot innovatie, maar ook tot een (betere) betaalbare en meer toegankelijke gezondheidszorg. Dit is tijdens de…
Lees meerGuidance on standardisation for medical devices (Medical Device Coordination Group)
Author: Medical Device Coordination Group Publication date: April 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745.The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it. The document is not a European Commission document…
Lees meerLiberalisation of the Distribution of Medical Devices (NautaDutilh)
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 pharmacies. A royal decree which…
Lees meerAre Wearables Medical Devices Requiring a CE-Mark in the EU? (Covington)
Authors: Charlotte Ryckman and Delphine Marchal (Covington) Publication date: 18/01/2019 Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many…
Lees meerSoftware 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 act directly in or on…
Lees meerEU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices (Covington)
The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”). In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) do not fall within the…
Lees meerBelgium – Sunshine Act (Van Bael & Bellis)
On 23 June 2017, the Belgian Official Journal contained the Royal Decree of 14 June 2017 implementing the Sunshine Act (“Koninklijk Besluit van 14 juni 2017 tot uitvoering van de Sunshine Act”/”Arrêté royal du 14 juin 2017 portant exécution du Sunshine Act”)(the “Royal Decree”). As its name indicates, the Royal Decree offers the practical details necessary to…
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