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Healthcare sector - LNE's newsletter

Regulatory changes in the market, expert opinions, LNE news…

>> N°11 - July, 2017

>> Application of the European MD and IVD Regulations: LNE / G-MED's strategy in conducting the changes
The European Regulations on Medical Devices including Active Implantable Medical Devices (AIMD), and In Vitro Diagnostic (IVD) Medical Devices have been officially published on May 5th, 2017. Both will enter into force on May the 25th, 2017. In addition to their major impact on Medical Device Manufacturers' responsibilities, they significantly modify the tasks of Notified Bodies such as LNE/G-MED.
In order to maintain the confidence of Manufacturers whose medical devices we certify and guarantee the sustainability of our services, LNE/G-MED, together with its subsidiary G-MED North America, has established a strategy to obtain its Designation as a Notified body under the new European Medical Device and In Vitro Diagnostic Regulations, which will enter into force in the near future.

>> Cyber security for medical devices: an overview of applicable regulations
An ever increasing number of medical devices are being connected to hospital information networks via various types of connection (4G, Wi-Fi, bluetooth and ethernet). At the same time, more and more cases of issues associated with hacking, piracy and even theft of personal medical data are being reported in the media.
It is therefore appropriate to examine the current regulatory position vis-à-vis connected medical devices.

>> Minimising risks in the development phase of e-healthcare products and optimising regulatory strategy for the European market
Nowadays, e-healthcare technology is omnipresent in the field of medical devices. It is leading to a long-term revolution in therapeutic processes and paradigm of patient management, notably in the area of mobile healthcare. Market opportunities for such ground-breaking medical software systems are becoming increasingly attractive for an ever growing number of innovative companies. However, one can only notice that the developers of these digital technological solutions are relatively ignorant of the regulatory issues that they will be required to tackle in order to market their mobile healthcare products in Europe.

>> How to optimise the useful life of medical devices?
Due to changes in society's attitudes regarding production and consumption, questions such as sustainable development and the circular economy must now be taken into consideration when developing new products. Although the issue mainly concerns manufactured consumer goods, the trend is also being observed in the medical sector.

Archives

N°10 - October, 2016

N°9 - June 2015

N°8 - December 2014

N°7 - July 2014

N°6 - February 2014

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