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).
Technology and innovation
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.
European Commission published first GDPR evaluation report
More information on the findings of the EC's first evaluation on the effectiveness of the General Data Protection Regulation.
Data Strategy in the Medical Field: What's the Next Step?
MedTech Europe published a statement on the European Strategy for Data. Read about this step forward towards Europe’s digitalized health system here.
The upload of software into radio equipment – Commission’s Clarifications
All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!