Medical devicemedical device regulationclinical investigations of medical devicespost-marketing clinical follow-uphealthcarecalibratorMedical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, or software intended for use in the healthcare sector to diagnose, control, ...
GPR can act as your local agent in Europe and assists medical device and pharmaceuitcal companies to register their products with the EMA.
While fully supporting the aims of the revised European legal framework for medical devices, CIRSE is aware of the difficulties and risks that the transition to the Medical Device Regulation (EU) 2017/745 (MDR) brings [1]. With the MDR being fully applicable, only 32 notified bodies have bee...
What is the purpose of the Medical Device Regulation (MDR)? The existing regulatory framework has been in place for nearly 30 years. Since it has been amended on an ad hoc basis during this time, there has been increasing pressure to modernize it to better address risk management and guarant...
2. Proposal for a regulation of the European Parliament and of the Council on Medical Devices. September 26, 2012. European Commission website. http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf. Accessed January 6, 2015. ...
medical devices to the European market first. Simply put, obtaining a CE mark was faster, cheaper, and more predictable than getting regulatory approval anywhere else. Those days are gone, however, and many medical device professionals are blaming...
European In Vitro Diagnostic Medical Device Regulation (EU-IVDR) Een aanzienlijke verbetering van het regulatory framework De EU-IVDR is in mei 2022 in werking getreden en heeft de Richtlijn 98/790/EG betreffende In Vitro Diagnostics Medical Device (IVDD) vervangen,...
As a full scope Notified Body for medical device CE marking, we can issue device-specific CE certificates and Declarations of Conformity for european access.
Medical devices regulationStandardsAfricaEuropeOpen Source Medical DevicesHarmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation....
THE IMPACT OF EU MDR AND EU IVDR ON THE ADOPTION OF MEDICAL TECHNOLOGY IN EUROPE New EU regulations came into effect for MedTech and IVD companies. TheEU Medical Device Regulation (MDR) 2017/745and theEU In Vitro Diagnostic Regulation (IVDR) 2017/746came into effect on May 26, 2021 and...