On November 3rd, 2020, Obelis and QUNIQUE announced a strategic partnership to exchange expertise and knowledge in the field of the MDR & IVDR
Medical devices and healthcare
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.
MedTech Europe raises industry concerns over the successful transition to the new IVDR
Trade association MedTech Europe has raised concerns over halted progress in transitioning to EU in-vitro diagnostic medical device regulation 2017/746.
Regulatory requirements for medical face masks – European Commission Guidance
The European Commission has issued market and compliance guidance on regulatory requirements for manufacturers of medical face masks.
Free Sales Certificates needed for medical device registration in Bosnia and Serbia
It is well known that for Medical and In Vitro Diagnostic Devices, the best tool easing the access to non-European markets is the Free Sales Certificate, which allows the manufacturer to prove the compliance of his devices with the EU laws and safety standards. These EU standards are then fully accepted and welcomed as the best possible ones also outside the European Union, typically as an official proof of compliance or generally to clear the Customs.