Regulatory

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.

FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in the frame of clinical studies (i.e. Investigational Device Exemptions IDE), or premarket regulatory submissions (i.e. 510(k), De Novo, PMA etc.).

Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical devices (or using novel manufacturing processes) navigate the regulatory processes so they can progress their technologies.

Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a manufacturer can begin a (moderate to high risk) clinical investigation of its medical device in the US.

ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international markets (i.e. Europe, Canada, Japan, Australia etc.).

The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable predicate exists.

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices.

The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III. De novo process allows these low risk devices to be re-classified via a request for a risk-based (re)classification from the FDA.

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.