Quality: from product compliance to patient care
Our robust quality management system maintains and improves the security, usability and performance of our medical devices and solutions so you can feel confident about the care you provide.
MDR at a glance
Under MDR, medical device manufacturers, importers and distributors are required to gather, record and analyse data on quality, usability and safety across each device’s entire lifespan. Manufacturers are also required to design and implement a post-market surveillance plan to enable monitoring and continuous improvement throughout the lifecycle of their medical devices.
To enable Resmed to meet its obligations under MDR and guarantee the highest standards of product quality and safety, our robust Quality Management System (QMS) collects:
- Passive data, including audit reports, complaints, MD reports and technical service activities,
- Proactive data, such as publications, clinical studies and customer surveys,
- Real-life data from our devices.
All of these data populate our PMSS (post-market surveillance system).
MDR FAQs
Medical Device Regulation (2017/745 – MDR) is a new European Union regulation that is due to come into force on 26 May, 2021. It replaces the existing Medical Devices Directive (Directive 93/42/CEE – MDD). MDR imposes strict obligations on all organisations that manufacture, import or distribute medical devices in the EU.
The main objectives of MDR are to:
- Improve the safety, quality and reliability of medical devices, in some cases by requiring medical devices to comply with additional safety and risk management requirements.
- Strengthen transparency of information for consumers: every medical device on the market will be given a Unique Device Identifier (UDI) code and registered in the EU Database for Medical Devices (EUDAMED).
- Enhance vigilance and market surveillance through mandatory pre- and post-market data collection across the entire lifespan of the device.
Resmed has worked intensively for more than two years to update its quality management system (QMS) and product portfolio documentation to align with the new MDR requirements. For Resmed products placed on the EU market:
- All Class I Resmed devices (e.g. batteries, Narval MAD, tubing) will be compliant with the new MDR requirements on 26 May, 2021.
- All other Resmed medical devices will transition to MDR certification gradually , starting in 2021 and concluding no later than 25 May, 2024.
MDR creates new responsibilities for Resmed to actively and systematically gather, record and analyse relevant data on its medical devices across their entire lifespan. These data must be used to determine, implement and monitor any preventive and corrective actions that could improve the usability, performance and safety of the device. Resmed is also responsible for establishing, implementing, documenting and maintaining a risk management system to estimate and evaluate any risks that may arise when the device is used as intended. Resmed is the data controller under GDPR and is accountable for the maintenance and management of its QMS.
Penalties for failing to comply with MDR can include fines, litigation, product recalls, financial damage and a loss of access to markets and materials, as well as reputational damage.
Keep exploring
Compliance
Our compliance with regulations such as MDR and GDPR supports your ability to operate effectively and in a fully compliant manner in the modern healthcare environment while keeping data safe and private.
Security
Our expert teams take an proactive approach to managing the complex challenges of end-to-end information security. We respect regulatory requirements and best practices in order to maintain confidentiality and protect data integrity.
Privacy
Our secure, certified systems and processes protect the privacy and confidentiality of sensitive patient data and help you to meet your health data obligations under GDPR.