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).
News
Webinar: MDR Compliance for Legacy Devices
In this webinar we provide an overview of Legacy devices, requirements to be respected, EUDAMED Actor Registration
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.
New Chinese Safety Standard for Electric Vehicle Batteries
On May 12, 2020, the Chinese government has published a new safety standard for batteries of electric vehicles, the GB 38031-2020 standard.
Cosmetics products on the UK market after January 2021
All non-UK manufacturers who wish to sell their products in Great Britain after January 1, 2021, must appoint a UK-based RP by that date. Find out more!
Nanomaterials in Cosmetics: Tiny Pieces (of Concern)
The SCCS published the Scientific Advice on the safety of nanomaterials in cosmetics, shedding some light on this rather obscure aspect of the cosmetic industry.
Central traceability system & implant cards mandatory as of May 2021
As of May 1, 2021, notification of the insertion and removal of implantable devices will become mandatory in Belgium for stents, mechanical cardiac and ophthalmological implants, and some other implants
EU Chemicals Strategy: road to a toxic-free environment
The EU Chemical Strategy for Sustainability aims to build a zero-pollution environment in line with Europe’s new agreement towards a toxic-free Union: The Green Deal.
What is going to be the consequence of Brexit for the labelling of aerosols in the UK?
In September 2020, a guidance was issued on the use of the UKCA mark from January 1, 2021, as a substitute for the CE mark on the UK market.
Food Supplements in the EU: regulatory framework & national registrations
Regulatory Framework & National Registrations information for manufacturers who want to place their products in the EU market.