Useful information on the scope and main changes introduced under the new European General Data Protection Regulation, entering into force in May 2018.
Technology and innovation
Challenges When Designing a Mobile Medical App for Safe and Effective Use
As application designers have begun taking advantage of the advancements of technology and the growing patient trend for self-diagnosis and treatment, regulators have begun scrutinizing mobile medical apps.
Not only UVA and UVB
The use of screens, smartphones and tablets expose the skin to blue light, that can lead to health issues. Find out how cosmetics can protect from blue and infrared light.
Electronic cigarettes are to be regulated as medical devices if they do not contain nicotine
How can a manufacturer decide on the classification of their electronic cigarettes?
Find out how E-cigarettes need to be regulated in the EU Market.
Post-market surveillance under the MDR: New requirements
Post-market surveillance requirements are strengthened under new EU medical device regulation 2017/745. Find out what implications it has for your device.
New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published
Learn more about the objectives and main amendments of new EU Waste if Electric & Electronic Equipments regulation 2012/19/EU.
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 new CE marking process for the Low Voltage Equipment
The new European Low Voltage Directive (LVD 2014/35/EU) outlines a new CE marking process for equipment on or to be introduced to the EU market.
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
What is the CE Marking Process?
The Obelis' team break down and explain the European CE marking process and the steps required in obtaining a CE mark for a product or device on the EU market.