US
Medical devices are regulated by FDA under the Federal Food, Drug and Cosmetics Act and are classified by increasing risk in Class I (low), Class II (moderate) and Class III (high), with regulatory controls increasing with each class.
Depending on the class, a manufacturer may need to submit a Premarket Notification (510(k)) when a substantial equivalence to a device already on the market can be demonstrated, or a rigorous Premarket Approval (PMA) for high-risk, novel devices.
Manufacturers must comply with quality System (QS) regulations (21 CFR Part 820), Medical Device Reporting (MDR) for adverse events and specific labeling requirements.
EU
Medical devices are regulated under the EU 2017/745 legal framework (EU MDR) which establishes provisions for the safety, performance and quality of medical devices marketed in union. It covers a broad range of products including certain software with medical purposes and certain aesthetic devices without medical purpose (e.g. color contact lenses, cosmetic implants, etc.).
Compliance with EU MDR is mandatory for all businesses wishing to sell medical devices in EU and key requirements include the following:
manufacturers must establish, document, implement and maintain a robust Quality Management System (QMS) aligned with ISO 13485 standard.
have a documented risk management plan throughout the entire product lifecycle.
manufacturers must provide rigorous and up-to-data clinical evidence to demonstrate device safety and performance.
have a Unique Device Identification (UDI) for the marketed medical device.
a proactive post-market surveillance system to monitor the device performance and safety after the product is placed on the market. Serious incidents must be reported to authorities within 15 days.
comprehensive technical documentation detailing the device’s design, use, manufacturing, risk analysis and performance available for review.
We offer comprehensive services to help our clients with all the necessary steps to secure optimal compliance with US and/or EU medical device regulations.
