Europe -
European Medical Device Regulation: The Compliance Advantage

Early compliance to the European Medical Device Regulation could give medical device manufacturers access to a potential $16.5 billion in revenues across the top 10 EU markets and Switzerland.

Nobody is in any doubt that the new European Medical Device Regulation (EU MDR) is on the agenda of compliance professionals in the medical devices industry. But is it far enough up on their priority list?

Early compliance to the European Medical Device Regulation—the outline of which was finally published in the Official Journal of the European Union on May 5, 2017—is crucial if manufacturers are to maintain access to EU markets, which in aggregate are economically larger than the United States.

The MDR replaces both the previous Medical Device Directive (93/42/ EEC) and the Active Implantable Medical Device Directive (90/385/EEC), and entails a raft of changes to the oversight of many critical processes in manufacturing (see sidebar "Key Issues for Compliance with the Medical Device Regulation (EU 2017/745)). Through a more transparent and comprehensive regulatory framework, the EU MDR is designed to improve clinical safety and fair market access for all medtech players while promoting innovation in the sector.

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International -
Management de la qualité : l’ISO 9004 relookée

« Petite sœur » de l’ISO 9001, la norme volontaire ISO 9004 vient d’être révisée. Elle donne des lignes directrices pour déployer un management de la qualité en vue d’obtenir des performances durables dans l’organisation. Comme l’ISO 9001 en 2015, la norme volontaire internationale ISO 9004, l’une de ses petites sœurs, vient d’être relookée. Orchestrée par le comité technique TC 176 de l’ISO (Organisation internationale de normalisation), dans lequel AFNOR représentait la France, la révision a débouché sur un texte publié en avril 2018, disponible dans la collection AFNOR ici neuf ans après...

USA -
FDA Clears FlowTriever, First Device to Pull Blood Clots from Lungs

Inari Medical of Irvine, California won the first FDA clearance for a thrombectomy device to be used for treatment of pulmonary embolisms. The FlowTriever went through a clinical study involving 106 patients with acute pulmonary embolism and RV/LV (right ventricular/left ventricular) ratio of at least 0.9 that were treated using the device instead of commonly used clot busters. According to the company, “the mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15 at 48 hours postprocedure, a difference of 0.39 (p<0.0001). The study also demonstrated excellent safety at 30...

International -
Real World Data Could Give Edwards Edge in TAVR

TAVR pioneer Edwards Lifesciences has released positive 30-day data of its Sapien 3 valve at EuroPCR. Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR . The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the...

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