In this webinar we provide an overview of Legacy devices, requirements to be respected, EUDAMED Actor Registration
Medical devices and healthcare
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.
Obelis Group & QUNIQUE form Strategic Partnership
On November 3rd, 2020, Obelis and QUNIQUE announced a strategic partnership to exchange expertise and knowledge in the field of the MDR & IVDR
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!
MDR: Common specifications for reprocessing of single-use devices
Common specifications for reprocessing single-use medical devices in Europe under EU medical device regulation 2017/745.
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.
Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU
The MHRA has released its latest guidelines for medical device requirements for products in Great Britain, Northern Ireland, and Europe from January 1st 2021.