On December 16, 2020, the European Commission published the EU’s Cybersecurity Strategy for the Digital Decade.
Read more about the topic in this article.
Technology and innovation
How MDR regulates software?
Artificial Intelligence (AI) has been used more and more in healthcare. Read our article to learn more about the challenges that manufacturers have to deal
The SCHREMS II CASE
Data transfer from the EEA to third countries -The finding of an adequate level of protection. The protection of personal data and its interaction with the MDR and IVDR
Germany becomes the first country in the world to reimburse the prescription of digital health applications
Following the Digital Healthcare Act (in German, DGV), 73 million insured in the German Statutory Health Insurance can access public healthcare by means of digital health applications (in German, DiGA).
Interview with Mr. Gideon Elkayam – The Obelis Group Founder & CEO
Through this interview, you will get more insight about Obelis. What are doing and how can we help you to compliance with EU regulations.
CBD acceptability in the EU after the latest ECJ judgement
The Kanavape Case (C-663/18) judgment provides some much-needed clarity over the status of CBD in the EU and whether it should be classified as a narcotic substance.
EC publishes preliminary opinion on electronic cigarettes
Electronic cigarettes and any e-liquid containing nicotine are subject to the discipline set out by the Tobacco Products Directive 2014/40/EU (TPD).
General Data Protection – Compliance Process
Expert guidance on the compliance process for the processing of personal data in the European Union according to the GDPR Regulation. Learn more here.
New Motor Vehicle Regulation 2018/858 – Fully applicable from September 1, 2020
European Motor Vehicle Regulation 2018/858 entered full effect in September 2020. Talk to our EU regulatory experts about your vehicle or product's compliance.
Radio Equipment Directive – Obligations associated with the placing on the market
All the information you need on how to bring a product to market under EU Radio Equipment Directive 2014/53. CE marking, documentation, compliance and more.