Rapid antigen tests are not the most reliable methodology for COVID-19 diagnostic, but they can be a useful tool to face the ongoing pandemic because of their short turnaround times and reduced cost.
Medical devices and healthcare auto
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).
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.
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
Surveillance activities of medical devices in Italy: First report of the Competent Authority released!
The Italian Ministry of Health published first report on the surveillance activity it carries out on medical devices to ensure only safe and effective devices are circulating on the national territory.
Brexit Webinar: New UK guidelines explained
The UK giving new UK regulations to be applied to medical device manufacturers wishing to place their products on the UK Market after January 1st 2021.
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).
Swiss Medtech calls for the update of the Mutual Recognition Agreement with the EU
With MDR quickly approaching, the Swiss Medtech urges for solution to eliminate technical barriers to trade medical devices in the EU. Read more here!