Are you seeking guidance on navigating the complexities of EU MDR & EU IVDR compliance, especially with regards to Section 10.4.1?
At Acquis Compliance, we understand the importance of protecting public health and helping businesses thrive within regulatory frameworks. Our comprehensive software, consulting, and services empower Medical Device companies to achieve compliance with the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Medical Device Regulation (IVDR) and help you to determine the warning label requirement for Section 10.4.1 substances. Let us be your trusted partner in managing EU MDR & EU IVDR requirements effectively and efficiently.
Identify chemical hazards in your products with red flag alerts for the substances of concern.
Determine the warning labels requirement and consumer notifications.
Seamlessly source and verify documentation, ensuring compliance.
Manage ongoing compliance monitoring effortlessly.
Track and monitor changes in the EU MDR & EU IVDR hazard chemical list, including any changes to Section 10.4.1 substances.
Simplify documentation and reporting processes for compliance submissions.
Automate the assessment of product, components and materials for potential EU MDR & EU IVDR substances, including Section 10.4.1 substances
Streamline supplier communication and data exchange to ensure accurate and up-to-date chemical information
Proactively manage risks associated with EU MDR & EU IVDR by leveraging comprehensive analytics and tracking tools
Establish a centralized repository for auditable documentation, facilitating efficient compliance management and collaboration
Benefit from expert consulting and training services to enhance your understanding of EU MDR & EU IVDR, Section 10.4.1, and consumer safety practices
By partnering with Acquis Compliance, you can enjoy a wide range of benefits for your EU MDR & IVDR compliance efforts:
Book a demo or contact our sales team to learn how Acquis Compliance software and services can simplify your journey toward EU MDR & EU IVDR compliance while ensuring consumer safety.
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The EU MDR (Medical Device Regulation) is a new regulation that came into effect in May 2021, replaced the previous Medical Device Directive (MDD) and significantly strengthened the regulatory framework for medical devices in the EU. It sets out new requirements for the design, manufacturing, and clinical evaluation of medical devices.
The EU IVDR (In Vitro Diagnostic Medical Devices Regulation) is a new regulation that came into effect in May 2022. It sets out new requirements for the design, manufacturing, and clinical evaluation of in vitro diagnostic medical devices.
EU MDR applies to medical device manufacturers, importers, and distributors operating within the European Union.
The EU MDR and the EU IVDR are both complex regulations, but there are some key differences between them. The EU MDR applies to all medical devices, while the EU IVDR only applies to in vitro diagnostic medical devices. The EU MDR also has more stringent requirements for risk management and post-market surveillance.
Acquis Compliance software automates data collection, substance analysis, compliance monitoring, and reporting processes, streamlining your EU MDR compliance efforts and ensuring adherence to regulatory requirements.
The consequences of non-compliance with the EU MDR or EU IVDR can be severe. Manufacturers who are found to be non-compliant may be subject to fines, penalties, and product recalls. They may also lose market access in the EU.
To get started with Acquis Compliance, simply contact us and we will be happy to answer any questions you have and help you get started.
There are a number of things that you can do to ensure that your medical devices are compliant with the EU MDR or EU IVDR. These include:
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