What Are the New Regulations for In-Vitro Diagnostics
The new Medical Devices regulation for In-Vitro Diagnostic also known as In-Vitro Diagnostics Regulations (IVDR) was adopted by the EU in April 2017 and came into force in May 2017. The...
Activating Your Distributor Network: Medical Device Industry
After researching, selecting and engaging your distributor, it is important to activate the distribution network. To make sure the distribution network delivers, you need to invest some...
What Buyers Care About Most When Shortlisting New Suppliers
The buying process in the medical device & diagnostic industry has always been demanding, requiring complex and lengthy decisiveness. Many buyers prefer to carry out extensive research,...
EU Medical Devices Regulations – Unique Device Identifier (UDI)
The new EU medical device regulations (MDR) were adopted by European Union in April 2017 and came into force in May 2017. The application dates of these regulations apply as of May 26th...
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...
Entering the European Digital Healthcare Market
The European digital health market is predicted to grow at a CAGR of 27.1% from 2020 to 2025. The exceptional growth comes from the increase in demand for remote healthcare services for...
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...
