Successfully Identifying and Selecting Your International Medical Device Distributor
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 set of unique challenges, particularly in the realms of distribution and logistics. Selecting the right international medical device distributor is a critical decision […]
Mastering Medical Device Distribution in Europe and the Middle East: Pricing strategies and considerations for successful channel sales
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 distributors, logistics and distribution planning, and selecting the right distributor. In this article, we’ll explore the intricacies of learning to master medical device […]
The Differences Between a Distributor and Importer Under the MDR/IVDR Regulations
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 important because distributors and importers share many responsibilities and sometimes do similar things. However, their jobs and thus the MDR/IVDR Regulations they must […]
Stocking Medical Devices in Europe: what to consider
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 device (MD) market in the European Union (EU) is projected to reach €130 billion by the end of 2022. The industry is steadily […]
When Does Your Medical Device Need CE Marking to Export to Europe?
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 to Export to Europe? The European medical technology market was estimated to be worth €140 billion in 2020. This is a promising market […]
The Different IFU Requirements for Medical and In Vitro Diagnostic Devices in the EU
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 economic operator’s (EO) conformity with technical requirements to ensure medical devices in the market are safe to use. We explained IFU requirements in […]
Is your Medical Device Importer in Europe MDR/IVDR compliant ?
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 responsible for placing products on the EU market. At the end of the day the manufacturer remains responsible and liable for the […]
EUDAMED Registration: A Step-By-Step Guide
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 provisions of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is to have medical devices and in vitro diagnostic […]
Reasons not to appoint your European distributors as your medical device (MDR) importer
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 2021, revisits the entire supply chain and economic operators, namely: the manufacturer, authorized representative, importers, and distributors. Each economic operator will have replaced […]
MDR Importer Role for Software as a Medical Device Companies
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 only continue to rise. Software as a Medical Device (SaMD) is a rapidly growing industry. In 2019, it […]