Switzerland non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?Switzerland - non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?Since 2002, a Mutual Recognition Agreement (MRA) has linked...
New lists of harmonised European standards under the Medical Devices (MD) and IVD Regulations have been published in the Official Journal of the European Union. There are now 14 standards harmonised under the MD Regulation and 9 standards harmonised under the IVD...
The European Commission published on December 14 in the Official Journal of the EU the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use for medical devices...
In order to ensure a continuous supply of in vitro diagnostic medical devices, the European Commission proposes to extend the periods initially foreseen in the Regulation concerning the transitional provisions. Please note that this proposal does not aim to change the...
The normative environment for the biological evaluation of medical devices has changed significantly in recent years. The 2018 version of ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process has led to...
The new in vitro Diagnostic Regulation (EU) 2017/746 (IVDR) which replaces the IVD Directive (98/79/EC), entered into force on May 25th 2017, and will enter into legal application by 26 May 2022 after a 5-yeartransition period. Team-NB published a consideration...
Given the exceptional circumstances of the COVID-19 epidemic, the European Commission published a Notice on 11/01/2021 that temporarily allows notified bodies to perform remote conformity assessments of manufacturers QMS under the MDR/IVDR. Certain conditions...
It is not a surprise, the obligations of distributors are now specified in the European medical devices (MD) and in vitro medical devices (IVD) Regulations, whereas the Directives did not mention it. But what about their obligations regarding UDI and EUDAMED, the two...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
