Linda Horton says changes won't affect U.S. companies much. Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system ...
It’s no exaggeration to say that the European Medical Device Regulation (EU MDR) is one of the most impactful pieces of legislation to hit the industry in decades. It was established to ensure a ...
The 2007 directive expands the existing definition of a medical device to cover "any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, ...
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical ...
The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to ...
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced ...
The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
In a decision that will disappoint medical device manufacturers, the CJEU in the Boston Scientific case has addressed the authorisation that must form the basis of an SPC. This is in contrast to ...
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