Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
Medical devices and healthcare
Medical apps under the new European MDR
Exploring the differences and between medical and well-being apps under the scope of EU medical device regulation 2017/745 and their legal requirements.
The importance of GMDN Codes
According to the European Commission decision from 19th April 2010, uploading data into EUDAMED requires the use of GMDN codes. Read more on this topic.
New EU Borderline and Classification Manual on Medical Devices
A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
New European Notified Body Product Codes Open for Consultation
Public consultation has been opened on the implementation of the new notified body product codes under the oncoming EU medical device and IVD regulations.
Upcoming changes in Medical Devices Regulation in Australia
A number of changes have been made to Australian medicines and medical devices regulations to improve consumer access and remove red tape for manufacturers.
Are E-Cigarettes regulated as Medical Devices ?
Electronic cigarettes work by heating up a liquid until vaporization is reached. This is essentially another way of putting nicotine into your body. How are electronic cigarettes being regulated under the EU Law ? Are these to be considered as tobacco products or something else ? Read more on this topic
Newly defined devices under the IVDR
New EU regulation shifts in-vitro device classification from list-based to risk-based, allowing for greater innovation and scope for manufacturers in Europe.
EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices
EU vote confirms cranberry products are not medical devices. This is the first borderline product ruling adopted based on MDD 13(1)(d).
Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460
DNV GL Nemko Presafe NB2460 began operating in May 2017, a merger of former Norwegian notified bodies DNV GL Business Assurance Norway and Nemko AS NB 0470.