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
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
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
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:
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.
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,
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
Economic Operators and the CE Mark on Medical Devices If you’re a medical device manufacturer, supplier, or importer but aren’t knowledgeable about the European Union
Companies exporting medical devices to the EU must comply with MDR labeling requirements, or they may face fines, sanctions, or lose access to the EU
The new MDR / IVDR requires specific and new labeling requirements for Medical Devices imported in Europe. We provide a summary of how devices entering