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Guidance on standardisation for medical devices (Medical Device Coordination Group)

Author: Medical Device Coordination GroupPublication 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

2021-04-17T09:35:17+00:00 17 april 2021|Categories: Medisch recht|Tags: |

Liberalisation 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

2019-02-19T10:35:28+00:00 19 februari 2019|Categories: Gezondheidszorg Pharma & lifesciences|Tags: , |

Are 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

CJEU rules on ‘tender shaping’ practices in the medical device sector (Loyens & Loeff)

Authors: Valentijn De Boe en Felix Feyt (Loyens & Loeff) Publication date: 10/01/2018 On 25 October 2018, the CJEU ruled in Case C-413/17 on the margin of discretion of contracting authorities to establish technical specifications in relation to medical devices. According to the CJEU, contacting authorities are free to refer to

2019-01-14T09:40:01+00:00 14 januari 2019|Categories: Medisch recht Overheidsopdrachten|Tags: , , |

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

2017-12-30T11:10:08+00:00 30 december 2017|Categories: Gezondheidszorg Pharma & lifesciences|Tags: , , |

EU 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”)

Belgium – 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

Borderline products: Cranberry products cannot be regarded as medical devices (Loyens & Loeff)

The European Commission’s Regulatory Committee on Medical Devices has adopted a Commission Decision on the qualification of cranberry products. According to the Decision, cranberry products do not fall within the definition of medical devices set out in the Medical Devices Directive. The European Commission’s Regulatory Committee on Medical Devices has

2017-06-06T16:13:16+00:00 6 juni 2017|Categories: Pharma & lifesciences|Tags: , , |

Dispositif médical non conforme : qui est responsable? (Droit & Technologies)

Tout en soulignant que la responsabilité du fait d’un dispositif non conforme repose en premier lieu sur le fabricant, la Cour admet qu’il est possible d’étendre cette responsabilité à « l’organisme notifié » qui intervient dans le cadre de la procédure relative à la déclaration « CE » de conformité.

2017-05-12T13:45:20+00:00 12 mei 2017|Categories: Pharma & lifesciences|Tags: , |

Voici le nouveau cadre juridique pour les dispositifs médicaux (Droit & Technologies)

Il existe plus de 500 000 types de dispositifs médicaux (y compris les dispositifs médicaux de diagnostic in vitro) sur le marché de l’UE, par exemple les lentilles de contact, les appareils de radiographie, les stimulateurs cardiaques, les implants mammaires, les prothèses de hanche, ou encore les emplâtres adhésifs. Les

2017-04-27T09:53:58+00:00 27 april 2017|Categories: Pharma & lifesciences|Tags: , |