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.
Natural Substances in Europe: A new initiative to boost knowledge and safety
In 2016 UNITIS, an Organization of Cosmetics Ingredients Industries and Services, launched the NCS TOX Project to boost knowledge of natural substances.
EU Clinical Trials Database delayed until 2019
The implementation of clinical trials is to be delayed until 2019 due to technical difficulties according to the European Medicines Agency.
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.
Revised guideline on first- in-human clinical trial
From February 2018, new guidelines will enter into force on in-human clinical trials. Talk to Obelis about the implications this may have for your products.
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