ON-o-meter : suivi des notifications pour le règlement 2017/745

6 novembre 2019 Règlement (UE) 2017/745
dernière modification : 8 novembre 2019


Vous voulez savoir quels sont les organismes notifiés pour le règlement (ue) 2017/745 relatif aux dispositifs médicaux ?
Vous avez raté un épisode et ne savez plus quels ON sont toujours en course ?
Cette page reprend les informations relatives aux notifications, issues de NANDO ou des sites des organismes.
Les ON ayant fait part de leur abandon sont listés en fin de tableau.
En tout, ce sont plus de 40 organismes qui ont postulé.

Organismes notifiés our le règlement (UE) 2017/745


# ON Pays Notif. Limitations Score Scope
1 BSI Assurance UK Ltd BSI Assurance UK Ltd 0086 drapeau Royaume-uni 19/01/19 MDN 1214 478 🔗
2 TÜV SÜD Product Service GmbH Zertifizierstellen TÜV SÜD Product Service GmbH Zertifizierstellen 0123 drapeau Allemagne 27/05/19 MDN 1104 265 🔗
3 BSI Group The Netherlands B.V. BSI Group The Netherlands B.V. 2797 drapeau Hollande 06/11/19 MDN 1210, MDN 1214 176 🔗
4 DEKRA Certification GmbH DEKRA Certification GmbH 0124 drapeau Allemagne 14/08/19 MDA 0314, MDN 1104′, MDN 1213, MDS 1002, MDS 1012, MDT 2013 101 🔗
5 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. 0051 drapeau Italie 20/08/19 B. Non-active devices (classe III) 100 🔗
6 TÜV Rheinland LGA Products GmbH TÜV Rheinland LGA Products GmbH 0197 drapeau Allemagne 26/09/19 MDA 0101, MDA 0305, MDA 0307, MDN 1101, MDN 1102, MDT 2009 47 🔗
7 DARE!! Services B.V. DARE!! Services B.V. 1912 drapeau Hollande 05/11/19 MDA 0307′, MDS 1005, MDS 1009, MDS 1011, MDS 1012′ -28 🔗
UL INTERNATIONAL (UK) LTD UL INTERNATIONAL (UK) LTD 0843 drapeau Royaume-uni 03/06/19 🔗
LLOYD'S REGISTER QUALITY ASSURANCE LTD LLOYD’S REGISTER QUALITY ASSURANCE LTD 0088 drapeau Royaume-uni 13/06/19 🔗
QS Zürich AG QS Zürich AG 1254 Suisse 20/07/19 🔗

Explications sur le classement

Un score indicateur est calculé : 1 point par jour entre la date notification et la date mise en application du règlement, le 26 mai 2020.
Un malus est attribué en fonction des limites du périmètre de notification, les malus sont donnés ci-dessous :
(ceci est totalement arbitraire)

Code Limitation Malus
MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices Annex X and XI(B) limited to gloves -15
MDN 1104 Non-active soft tissue and other implants Annexes X and XI without breast implants -100
MDN 1104′ Non-active soft tissue and other implants excluding breast implants whose purpose is the enlargement or replacement of the volume of the breast -0
MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART) excluding IVF and ART; limited to devices for cryopreservation -60
MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases Annex X and XI(B) Limited to male condoms -10
MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route excluding devices for ingestion -90
MDS 1002 Devices manufactured utilising tissues or cells of human origin, or their derivatives restricted to devices manufactured utilising human serum albumin (HSA) -30
MDS 1005 Devices in sterile condition Limited to ethylene oxide gas sterilisation and radiation sterilisation -40
MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices Only for active devices 0
MDS 1011 Devices in systems or procedure packs Only devices in systems, procedure packs are excluded -30
MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 excluding products according to section 3 of annex XVI -20
MDS 1012′ Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 Only for active devices. Code will be only applicable as of the date of application of the relevant common specifications referred to in Article 1(2) of the MDR. -70
MDT 2013 Devices which have undergone reprocessing excluding reprocessing of single-use devices -45
B. Non-active devices Excluding class III devices -180
MDA 0101 Active implantable devices for stimulation/inhibition/monitoring limited to stimulation devices excluding brain stimulators and pacemakers -45
MDA 0305 Active non-implantable devices for stimulation or inhibition excluding brain stimulation devices -30
MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis Limited to devices for administration and removal of substances -30
MDA 0307 Active non-implantable respiratory devices excluding hyperbaric chamber -15
MDA 0307′ Active non-implantable respiratory devices Excluding inhalation anaesthesia devices, lung ventilators and heart-lung machines -60
MDN 1101 Non-active cardiovascular, vascular and neurovascular implants excluding heart valves introduced into the body by open heart surgeries -30
MDN 1102 Non-active osteo- and orthopaedic implants excluding joint implants -30
MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin excluding “under processing of materials of human origin” -45