The conformity assessment procedure is the regulatory path that allows the manufacturer (or the notified body if applicable) to assess the conformity of a device before it is placed on the market. There are several possible path, depending on the class of the device....
UDI and EUDAMED are two KEY new features of the MDR. But practically speaking, as a manufacturer, what will you actually be required to do? Let's recap! 1) To get started, you will need to assign a UDI to the device and all higher levels of packaging and assign a...
In September, the UK's MHRA published two major guidances concerning the regulatory environment for medical devices (MD) in the UK, applicable from January 1, 2021 (end of the transition period): The first one, very comprehensive, relates to the regulation of MD after...
The Commission published on August 19 the Implementing Regulation (EU) 2020/1207 laying down rules for the application of the MD Regulation as regards common specifications for the reprocessing of single-use devices. This implementing Regulation lays down rules where...
In a major ruling on July 16 (see press release), the Court of Justice has provided us with guidance on what it considers to be "an adequate level of protection" for personal data transferred to a third country under the GDPR. It ruled on the inadequacy of the levels...
The French notified body GMED (number 0459) has just been designated in accordance with the MDR ! It is the 15th notified body to successfully pass the designation milestone. Its designation perimeter is among the most expanded. It is available on the NANDO database...
Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch? The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to...
As the world continues to be hit hard by the COVID-19 pandemic, the European Union is facing shortages of necessary personal protective equipment (PPE) and medical devices, such as face masks. Given the surge in demand for these products, legislative measures have...
The European Council published, on the 22nd February 2017, the final text of the Regulation on medical devices. This text changes and replaces the proposal for a regulation published on the 9th august 2016, which had obtained a political agreement on the 20th...
Are you ready for change? We have finally got there... The Regulations on medical devices and in vitro diagnostic medical devices were published on 5th May, 2017 in the Official Journal of the European Union. We can now put a name (and finally ... a number) to these...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
