Expanding into new markets, such as Europe or the Middle East, can be a significant opportunity for medical device manufacturers looking to grow their business. However, venturing into these regions brings a
Expanding into international markets like Europe and the Middle East offers tremendous growth potential for medical device manufacturers. However, success in these regions hinges on various critical factors, including pricing strategies for
Understanding what distributors need to do under EU MDR and IVDR is a complicated topic. First, let’s make sure we are on the same page about what a distributor is. This is
If you are a non-EU manufacturer, you must comply with the Medical Device Regulation (MDR). The Regulation states that manufacturers must select an importer to meet the requirements and be liable and
The instructions for use (IFU) pertaining to medical devices substantially differ between the Medical Device Regulation (MDR) and the Medical Devices Directive (MDD). Despite the distinction, however, their IFU should demonstrate an
The CE Mark is mandatory for medical devices Imported to Europe. Learn how your products can get CE marking based on Medical Device Regulations. When Does Your Medical Device Need CE Marking
Stocking medical devices in Europe will help economic operators maintain a competitive advantage. Here are things to know about EU medical devices logistics. How To: Stocking Medical Devices in Europe The medical
How do you register medical devices to the European database for medical devices or EUDAMED registration? This step-by-step guide has all you need to know. EUDAMED Registration: A Step-By-Step Guide One of
The Role of Importers in MDR Compliance for Software as a Medical Device (SaMD) Companies As multiple facets of high-end technology are leveraged in healthcare, the use of software in medicine will
Under the old medical device directives (MDD 93/42/EEC), the requirement for a distributor is not mentioned, while the word MDR importer appears three times. The new MDR (2017/745) implemented per May 26th