The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers looking to market their medical devices in the EU, understanding the classification and certification process is crucial. In this blog, we'll delve into the intricacies of EU MDR compliance and CE certification, with a focus on Class I medical devices.
Understanding Class I Devices
Class I medical devices encompass a broad range of non-invasive products that pose the lowest risk to patients. However, Class I is not a one-size-fits-all category; it includes several subclasses, each with its own characteristics:
General Class I: These devices are non-sterile and have no measuring function, representing the lowest risk category. Examples include wheelchairs, plasters, and hospital beds. These devices are Self-Certified and Notified Body certification is not required for these devices.
Class Is (Sterile): Devices placed on the market in a sterile condition fall under this subclass. Examples include personal protection kits. Notified Body certification is partially required.
Class Im (Measuring): Devices with a measuring function belong to this subclass. Examples include stethoscopes, thermometers, and weighing scales. Notified Body certification is partially required.
Class Ir (Reusable): This new subclass includes products that can be reprocessed or reused in some way, such as surgical instruments and endoscopes. Notified Body certification is partially required.
The Significance of CE Certification
The CE marking is a critical standard for medical devices intended for the EU market. It signifies that a device complies with regulatory requirements necessary for entry into European countries. Manufacturers must ensure regulatory compliance and secure CE marking for their products, regardless of whether they outsource any or all components of their manufacturing operations.
CE Certification of Class I Medical Devices
Class 1 devices are generally associated with minimal risk, while medical devices in Classes Is, Im, and Ir are characterised by relatively low to medium levels of perceived risk. The non-sterile and non-measurable Class I devices can obtain CE marking through self-declaration as per EU MDR, eliminating the need for Notified Body certification or approvals from certification bodies. This allows manufacturers to self-certify their devices, making the process more streamlined. Manufacturers of Class I products not requiring Notified Body certification are responsible for creating and maintaining the necessary documentation at their manufacturing facility.
Steps for placing Class 1 Medical Device on the EU market
Actions following the placement of a Class 1 Medical Device on the EU market involve gathering and assessing Post Market Surveillance Data, overseeing the Vigilance system, and addressing non-conforming products.
In the event that a manufacturer discovers a device they have released on the market or put into service does not comply with the EU MDR, they will promptly initiate corrective measures to ensure the device's compliance. This may involve bringing it into conformity, withdrawing it from the market, or initiating a recall, as deemed appropriate.
QMS Requirements for Class I medical device manufacturers
The Class I medical device manufacturer should have established a QMS that includes procedures describing how the following processes are conducted:
Risk management for medical devices
Management responsibility and resource management, including the Supplier Management
Strategy for regulatory compliance, including the conformity assessment process and change management
Technical documentation management
Clinical evaluation including Post-market clinical follow-up (PMCF)
Post-Market Surveillance (PMS) system and Vigilance reporting Procedures
Process/product monitoring & measurement and product improvement
Corrective Actions / Preventive Actions (CAPA)
Navigating EU MDR compliance and CE certification for Class I medical devices requires a comprehensive understanding of the regulatory landscape. Manufacturers must establish robust QMS, maintain meticulous documentation, and uphold their responsibilities as legal manufacturers to ensure compliance and uphold patient safety. By adhering to these requirements, manufacturers can confidently bring their Class I devices to the EU market and contribute to the health and well-being of patients across Europe.
Ready to Ensure Compliance for Your Class I Medical Device?
Navigating the complexities of EU MDR compliance and securing CE certification for your Class I medical device is crucial for market access in the European Union. Don't leave regulatory compliance to chance.
Contact Artixio today to get expert guidance and support in achieving CE certification and maintaining compliance. Our team is here to help you every step of the way, from documentation to quality management systems and more.
Take action now to bring your Class I medical device to the EU market with confidence and contribute to the health and well-being of patients across Europe.