Connected Medical Devices To Necessitate Clinical Evaluation Requires MDR

The now ubiquitous Internet of Things did not spare the Medical Devices segment, and what is commonly referred to as Internet of Medical Things or Connected Medical Devices is of course well within the MDR reach. One of the major changes introduced by the MDR, compared to the previous regulation, is that sufficient clinical evidence of the safety and performance of the device are not merely a recommendation any longer but an actual necessity. While no specific methodology is suggested by the MDR, the French Haute Autorité de Santé which is, among others, responsible for the evaluation and appraisal recommendation of Health Products and Technologies, recommends to use Randomized Controlled Tr

Advertising your medical device in France during the state of health emergency

Advertisement of medical devices is regulated in France by the Loi Bertrand. For certain types of medical device, advertising requires a prior authorisation by the ANSM (National Agency for the Safety of Medicines and Health Products) called a “visa”. The ANSM has published on their website an update on the “visa” procedures during the state of health emergency declared in France following the Covid-19 outbreak. According to the 1st article of the order #2020-306 dated March 25th, 2020, the period stretching from March 12th to June 24th, is “legally protected”. This implies that if you have submitted a visa application and the 2 months evaluation period by the ANSM was due to end within this

The European Commission's guide on medical devices in the Covid-19 context

The European Commission published on April 3rd, 2020 a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context. After recounting definitions of MD, AIMD and IVDMD, this document reminds about the legal requirements for placing those devices on the European market, as well as ways to verify and document their compliance. In addition, the European Commission's guide provides a detailed list of harmonised standards in the context of the Covid-19 crisis as well as the possibilities to derogate from normal conformity assessment procedures because of the urgency created by the Covid-19 outbreak. Download the complete guide he

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