Guidance on Classification Rule for in vitro Diagnostic Medical Devices aims to uniformly apply the classification rules stated in the new regulatory framework
Medical devices and healthcare auto
Rapid Antigen Tests use across Europe: the EU Commission’s Recommendation
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.
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
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.
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!
Brexit, what about UK-EU Trade?
The UK tax authority HMRC sent to businesses in GB a letter on how to prepare for new processes for moving goods between UK and EU from 01/01/21. Read more here!
Medical device procurement in Vietnam: How many Free Sales Certificates do you need?
Learn more about the new procedures for medical device procurement in Vietnamese public health facilities and free sales certificate requirements and limits.