EU Medical Device Regulation MDR 2017/745-Hopeway AMD B.V.

Medical Devices Regulation (EU) 2017/745 has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD).

-We follow the MDR requirements, which apply to all medical device products marketed in the EU, including the packaging of medical devices.
-Manufacturers must register themselves and their products and submit data through the Europe-wide EUDAMED database.
-Each medical device must carry a unique identification number (UDI), which must be applied to the product as well as to all higher-level packaging, with the aim of achieving unique identification and traceability of the product.

EN 868
The EN 868 standard is dedicated to the sterile packaging of medical devices and ensures that the packaging material does not compromise the sterility of the device during the sterilization process.

Material Safety and Compatibility
Ensure that packaging materials can effectively support various sterilization methods (e.g. steam sterilization, ethylene oxide, etc.) and maintain the sterility of the device.

Consistency and Reliability
Ensure that packaging maintains its physical strength and integrity after sterilization to prevent contamination.

EN ISO 11607
The EN ISO 11607 standard for sterilized packaging systems for medical devices is the core certification standard for sterile barrier systems.

Globally trusted quality
Ensures that packaging provides a sterile barrier throughout the entire life cycle of sterilization, transport, storage and use.

Comprehensive testing and validation
Products that comply with this standard pass rigorous physical tests, such as heat seal strength and leakage detection, to ensure that their performance meets the high demands of medical device packaging.

EN ISO 11140
The EN ISO 11140 standard focuses on sterilization indicators, i.e. to help test the effectiveness of the sterilization process.

Verification of sterilization effectiveness: Ensuring that the indicators used clearly and accurately indicate whether or not sterilization has been successfully carried out, avoiding the use of unsterilized instruments.

Multiple sterilization method applicability: Suitable for steam, ethylene oxide, radiation and other sterilization methods to ensure a wide range of application scenarios.

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EU Medical Device Regulation MDR 2017/745