Glossary Term
Low-Risk Device
Definition
A low-risk device is a medical device classified as having minimal potential to cause harm to patients or users. These devices typically support or monitor health but are not critical to sustaining life or treating serious conditions. Examples include bandages, examination gloves, or manual surgical instruments. Regulatory frameworks such as the FDA and EU MDR categorize these devices under Class I or Class I (non-sterile/non-measuring) for regulatory purposes.
Relevance to the MedTech Industry
Low-risk devices serve essential roles in healthcare by providing basic functionality or support. Their simpler design and usage requirements allow for faster regulatory pathways and cost-effective production, making them widely accessible in both clinical and consumer settings.
Additional Information & Related Terms
Related Terms
Class I Devices: Regulatory classification for low-risk devices under FDA guidelines.
Non-Invasive Devices: Devices that do not penetrate the body or disrupt tissue.
Good Manufacturing Practices (GMP): Regulations ensuring consistent quality and safety in device production.
Post-Market Surveillance (PMS): Monitoring device safety and performance after market release, even for low-risk devices.
Labeling Compliance: Ensures proper instructions and warnings are provided, even for simple devices.