EU MDR Compliance Software

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.

Regilient 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 Regilient, 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: - Developing a comprehensive compliance plan - Conducting a risk assessment - Gathering and documenting the necessary data - Providing clear and accurate labeling - Conducting post-market surveillance