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 […]
Labelling requirements for medical devices in accordance with the MDR and IVDR regulations
The new MDR / IVDR requires specific and new labeling requirements for Medical Devices imported in Europe. We provide a summary of how devices entering the European market should be labelled. A Comprehensive Guide to EU MDR Labeling Requirements Medical device manufacturers must provide detailed product labels to ensure patient safety. This article discusses the […]
MDR Labeling Requirements and Instructions for Use for Medical Devices Exported to the EU
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 market. Labeling Requirements and Instructions for Use of Medical Devices Exported to the EU under MDR The European Union (EU) Medical Device Regulation (MDR), implemented on May 26, 2021, mandates […]
Economic Operators and the CE Mark on Medical Devices
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 Medical Device Regulation (EU-MDR) and In Vitro Diagnostic Regulation (IVDR), it may be high time you did, as their implementation brings about significant changes to the way products get the […]
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 […]