EU Medical Devices Regulation – Unique Device Identifier (UDI)
The new regulations on medical devices (MDR) and in-vitro diagnostic (IVDR) medical devices were adopted by European Union in April 2017 and came into force in May 2017. The application...
New Medical Device labelling requirements in Europe
By 26th May 2022, all IVD equipment/devices will transition to the new medical device regulations EU 2017/746. This regulation will be mostly for devices that are for self-testing,...
UK Government UKCA
On January 31, 2020, the United Kingdom officially left the free trade area of the European Union. Since the end of the transition period on December 31, 2020, the European rules under...
Software as a Medical Device (SaaMD)
As of 26th May 2021, Regulation (EU), 2017/745 will officially be applied to all medical devices manufacturers and Medical Device Software (MDSW). These will replace the previous EU rules...
European Medical Device Regulations (MDR) - Regulation (EU) 2017/745
Europe is home to more than 50,000 types of Medical Devices and IVDs that range from plasters, software, breast implants to bigger machines like x-ray machines. The EU has a highly...
European Medical Tradeshows & Conventions 2021
In Europe, we see many tradeshows are currently postponed to July / September. North American companies attending virtual tradeshows & conventions are not happy with the outcomes. What is...
How the MDR and UKCA regulation will impact your sales
We sales & marketing people are in general not very much interested in regulatory stuff. However if you do not want your sales in the UK and Europe to be disrupted, it is important to take...
INTERVIEW: Evaluating the European expansion journey
In this 10-minute interview, Bionix shared their experiences concerning European expansion. What did they learn? Also, Bionix shared their thoughts on EuroDev's European expansion...
Why UK-based Medical Device Manufacturers should focus on European expansion: 5 reasons
If you haven’t considered expanding to Europe, or if you are interested to expand your current European footprint, now could be the time to consider a European sales strategy that could...
CanExport: helping Canadian SMEs expand in Europe
For Canadian manufacturers active in the healthcare industry, now might be the perfect time to expand into European markets. With plans to increase reimbursement of export expenses to...
