Overview software MDR & IVDR (OSMI)

Below this text you can find (medical) software, related to the CE-Classification. This is a temporary overview until the international Eudamed database is launched. When the Eudamed database is ready, we will make sure this software overview will be reused as much as possible. The goal of this software overview is to reduce the risk of software not meeting the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) in time and to prevent hospitals contacting their suppliers, requesting the same information as others. This OSMI platform is a collaboration of BMTZ and NVKI.

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MDR & IVDR maturity

(135 applications)
Product Version Description Supplier Class By Exp. date Notes Edit More
3-matic Medical SW intended for computer assisted design and manufacturing of medical expo- and ... Materialise NV I MDD 24-05-2024
3Mensio 3mensio Workstation is a software solution that is intended to provide Cardiolog... 3mensio IIa MDD 17-08-2020
3mensio Workstation 3mensio Workstation is a software solution that is intended to provide Cardiolog... Pie Medical Imaging B.V. IIa MDD 01-12-2022
4D Viewer 18 4D Viewer wordt gebruikt door de Prenatale diagnostiek (Verloskunde & Gynaec... GE Healthcare IIa MDD
Accu-chek Smartpix Analyse en verwerking diabetesgegevens Accu-Chek I MDD
Agfa Enterprise Imaging (Radiology/Cardiology) 8.x Opslag, beheer en raadplegen van radiologische DICOM beelden Agfa IIa MDD
AMBU View Registratie en overdracht ritgegevens ambulance NAVARA No medical software
APC Cardio Hypertensie management systeem I.E.M. mbH IIa MDD
Aqure data management systeem POCT Radiometer IVDR
Astraia 1.26.1 Obstetric and gynaecological database application Sorg-Saem B.V. IIa MDD
AutoSense OS Aanpasssoftware hoortoestellen Phonak IIa MDD
B-Scan Plus Ultrasonographic eye imaging Accutome IIa MDD
BIOTRONIK Pacemaker Programmer Software Biotronik IIb MDD
BrainRT 1 OSG IIa MDD
CAAS A-Valve CAAS A-Valve is a software product intended to support the interventionalist dur... Pie Medical Imaging B.V. IIa MDD 01-12-2022
CAAS IntraVascular CAAS IntraVascular has been developed to review and analyze intravascular images... Pie Medical Imaging B.V. IIa MDD 01-12-2022
CAAS MR Solutions CAAS MR Solutions is a modular software product intended to be used by or under ... Pie Medical Imaging B.V. IIa MDD 01-12-2022
Caas Qardia CAAS Qardia is a software product that facilitates the segmentation of cardiovas... Pie Medical Imaging B.V. IIa MDD 01-12-2022
CAAS Workstation CAAS Workstation is a modular software product intended to be used by or under s... Pie Medical Imaging B.V. IIa MDD 01-12-2022
CardioSoft ECG software GE Healthcare IIa MDD
CareLink Systeem CareLink Personal is software waarmee u gegevens van uw diabetesapparaten kunt d... Medtronic I MDD 19-07-2022
CaseViewer (Pannoramic) 3DHistech Ltd. I MDD
CDLJava Vragenlijst software Buro Tester No medical software
Centrasys EVS EVS-module van Centrasys CSC I MDD
CGM apotheek CGM I MDD
CLAUS Centraal Laboratorium Aanvraag- en Uitslag Systeem https://www.sanquin.org/nl/p... Sanquin No medical software
CMS Mediware Cyto Management System Mediware I MDD
Cochlear Osia fitting software Cochlear IIa MDD
COMPET&T Toegang tot de landelijke BasisRegistratie Personen (BRP, voorheen GBA) T&T Compet&t BV No medical software
Corpuls.manager ADMIN Franklin 2009 With corpuls.manager you combine this “loose” data and generate new knowledg... corpuls | GS Elektromedizinische Geräte G. Stemple GmbH III MDD 26-05-2024
Corpuls.manager ANALYSE Franklin 2009 Our server and data management solution corpuls.manager ANALYSE provides you wit... corpuls | GS Elektromedizinische Geräte G. Stemple GmbH III MDD 26-05-2024
Corpuls.manager REVIEW Franklin 2009 With corpuls.manager REVIEW you can look at the mission down to the second and i... corpuls | GS Elektromedizinische Geräte G. Stemple GmbH III MDD 26-05-2024
Corpuls.mission LIVE Franklin 2009 The optimal solution for telemedicine - corpuls.mission LIVE enables the exchang... corpuls | GS Elektromedizinische Geräte G. Stemple GmbH III MDD 26-05-2024
CVI42 Beeldanalyse radiologie CircleCVI IIa MDD
Dexcom Studio Verzamelen glucosemetingen Zkope Healthcare IIa MDD 10-11-2019
Diamant Diamant is an electronic dialysis patient file that supports the clinical workfl... Diasoft IIb MDD
Digitale doktersassistente - Chantal 1.0 Triage is een op chat gebaseerde informatiedienst die de initiële gebruikersinv... Zaurus B.V. I MDR
Digora KAVO IIa MDD 19-02-2018
DynaCAD Beoordelen MRI-beelden Invivo Corporation (Philips Healthcare) IIa MDD 29-07-2019
Dynaport Analyse bewegingssensoren McRoberts Nederland I MDD
Encore Pro Uitleessoftware BiPAP Philips Respironics I MDD
ESSEON-R Scoringsprogramma Het ESSEON-R scoringsprogramma is geen medische toepassing Hogrefe No medical software
ETS Electronic Test System (ETSTM) Sensing Unit 3M
EuroLabOffice Middleware voor lab Biognost IVDR
Evocs Fysicon I MDD
Extended IPU Verwerking resultaten hematologie analysers Sysmex IVDR
Ezis 5.2 EPD Chipsoft IIb MDD
FMD Brocacef mij niet bekend Betreft applicatie om geneesmiddeldoosjes bij het NMVS af te melden via de Broca... Brocacef BV No medical software
Forcare XDS XDS Philips I MDD
Gaston Alert Beslissingsondersteuning Gaston Medical I MDD
Gaston EKP Beslissingsondersteuning Gaston Medical I MDD
Genie 2 Fitting software Oticon IIa MDD
HD03 Hemodialyse monitor software Transonic IIa MDD 01-07-2018
HMS (Hypertension Management Software) 5.2 The HMS CS software and associated accessories are intended for the preparation ... IIa MDD
HScribe Uitlezen en beoordelen Holters Mortara Instrument IIa MDD
I-CAT FLX MV KAVO IIb MDD
ICD programming software ICD programming software Boston Scientific IIb MDD
ICD programming software Medtroninc IIb MDD
IDocument Document management Infoland No medical software
IDS (Sectra) Sectra IIa MDD
Intellispace portal Portal voor beoordelen radiologiebeelden Philips Healthcare IIa MDD
IPro2 Continous Glucose Monitoring System Medtronic IIa MDD
IQ Messenger Zorgallermering IQ Messenger IIb MDD
JiveX PACS Visus IIb MDD
Karyotypering IIa MDD
KIRO KIRO® Oncology Robotic Compounding System KIRO Grifols IIb
Libreview LibreView is een veilig diabetesbeheersysteem in de cloud dat zorgverleners en p... Abbott Diabetes Care
Lingwaves LingWAVES has become one of the most used system for professional voice and spee... Wevosys
LingWAVES Stem- en spraakanalyse pakket Van der Tol medische apparaten v.o.f.
LSFD v7 Het LSFD is een gespecialiseerd EPD voor ziekenhuizen en klinieken die zich bezi... eFertility No medical software
Maestro 9.0 Fitting software MED-EL IIa MDD
MammoXL Inzien mammografiebeelden Bevolkingsonderzoek Philips I MDD
MediCAD Software pakket voor plannen van orthopedische ingrepen Hectec
Medimo 2021-2 Elektronisch voorschrijf- en toedienregistratiesysteem voor zorginstellingen in ... Medimo BV I MDR
Meditra NTS Triagesoftware SemLab
MICRA Pacemaker programmer software Medtronic IIb MDD
Mimics Enlight - As an interface and image segmentation system for transfer of DICOM imaging in... Materialise NV I MDD 24-05-2024
Mimics inPrint Image segmentation and pre-operative simulation/evaluation SW Materialise NV I MDD 24-05-2024
Mimics Medical Image segmentation and pre-operative simulation/evaluation SW Materialise NV I MDD 24-05-2024
MMS Solar Software voor urodynamische metingen Medical Measurement Systems B.V. IIa MDD 04-07-2018
Mosaiq Plannen en uitvoeren van radiotherapiebehandelingen, inclusief de aansturing van... Elekta IIb MDD
Mosos CTG Verloskundige monitoring software BMA BV IIa MDD
Mosos Patiëntendossier Verloskundig patiëntendossier BMA BV I MDD
Motiva Telemonitoring software Philips Healthcare IIa MDD
Multi Urodynamic Instrument Urodynamisch meetsysteem van Dijnen Medical I MDD
Muse Cardiology Information System GE Healthcare IIa MDD
MyMerlinPulse implantable cardiac defibrillator (ICD) - App Abbot IIa MDD
Nexam Pro v3.1.3 Multi Urodynamic Instrument van Dijnen Medical I MDD
NVISION Uitleessoftware saturatiemeters Nonin I MDD
Oasis IIa MDD
Oasisnxt Aanpassoftware hoortoestel Bernafon IIa MDD
OmniPro Accept Dosimetry system IBA Dosimetry IIb MDD
OnlineSuite 3.x OnlineSuite is a central maintenance platform for B. Braun Space infusion pumps ... B. Braun Medical IIb MDD 26-05-2024
OS optiek Aanpoasssoftware hoortoestellen OS optiek IIa MDD
Otosuite Audiometrie software Veenhuis Medical Audio IIa MDD
Phadia250 Laboratory Systems ThermoFisher
Phadia250 ThermoFisher IVDR
Portavita Health Management Platform Antistolling Het Portavita Health Management Platform Antistolling (HMP) biedt functionalitei... Portavita BV I MDD
Prometec No medical software
ProPlan CMF Pre-operative simulation/evaluation SW Materialise NV I MDD 24-05-2024
RadiView Analyse van bloeddrukverschillen in kransslagaders; opsporen van vernauwingen. St. Jude Medical IIb MDD
Resolvigen Analyzer Resolvigen is not CE-marked under IVDR (or MDR) but supplier is workin... OrthoVision
ResScan Ventilator software Resmed IIb MDD
Rigiscan Uitlezen apparatuur voor erectiemetingen Gotop IIa MDD
RVC Clinical Assistant 2020.1.1 Software for acquiring, archiving, visualisation, quantification, reporting and ... RVC Medical IT B.V. IIa MDD 09-06-2023
RVC Clinical Insight 2020.2.1 Standalone software intended for viewing medical images and other medical data r... RVC Medical IT B.V. IIa MDD 09-06-2023
ScandiDos Delta 4 Quality assurance radiotherapie ScandiDos I MDD
Seca analytics Seca IIa
Sectra Dosetrack Monitoring stralingsdoses per patiënt Sectra I MDD
Sectra PACS PACS Sectra IIb MDD
Sectra RIS RIS Sectra I MDD
Sentinel Pathfinder Cardiology information system application software Itemedical IIa MDD
Sentrysuite 3.00 De Vyntus ONE is een systeem voor volledige pulmonaire functietesten (PFT) dat ... Vyaire Medical GmbH IIa MDD
Simplant Pro Dental planning software Dentsply IIa MDD
Somnologica Studio Software voor slaapdiagnostiek Natus IIa MDD
Sorin Connect Data management systeem voor cardiopulmonaire perfusie B. Braun Medical B.V. IIa MDD 16-09-2019
SpeechMagic SDK G2 Speech I MDD
SpeechReport Spraakherkenning G2 Speech I MDD
SPT Connect Specialist Uitleessoftware voor apparatuur tegen slaapapneu Philips I MDD
Stoma App 1.5 De Stoma App is een informatieve bron ter ondersteuning voor volwassenen die een... everywhereIM I MDR 28-02-2026
Symptomenzoeker.nl Symptomenzoeker Symptomenzoeker.nl No medical software
Synergy FMH medical IIb MDD
TheraView Positioning bewakingssystemen radiotherapie Cablon Medical BV IIa MDD
UltraiQ Applicatie voor het meten van de beeldkwaliteit van echografie toestellen. Appl... Cablon Medical No medical software
Urodyn Software voor urineflowmeter VCM Medical I MDD
Uroflow all De Uroflow software is geïntegreerd in het Multi Urodynamic Instrument (MUI) en... Van Dijnen Medical I MDR
Veye Lung Nodules Veye Lung Nodules is an AI-based solution for pulmonary nodule management on che... Aidence IIb MDR 01-10-2025
Viewpoint GE Healthcare IIa MDD
Visupac Eye digital image capturing and archiving Zeiss Medical Technology IIa MDD
Xcelera R4.1 Philips IIa MDD
Xcelera PACS Cardiology Image Management System Philips Healthcare IIa MDD
Xcelera QLab Kwantificering ultrasounddata Philips Healthcare I MDD
Xero viewer Radiologische viewer Agfa IIa MDD
Zenya 6.0.2 Zenya biedt organisaties software voor kwaliteits- en risicomanagement, die meeb... Infoland No medical software
Zorgdoc.PRO Validatie ZorgdocPRO Validatie verzamelt voor zorgverleners medicatie informatie over/van ... Zorgdoc NL BV I MDR