ANSM Outlines Exemption Process for Medical Devices Without CE Marking

“The American National Standards Institute (ANSM) has established a process for medical device manufacturers to request exemptions from CE marking requirements in cases where patient health benefits justify their use.

Key Points:
CE Marking Requirement: Ensures medical devices comply with safety and performance standards.
Exemptions Allowed: For custom-made devices, clinical investigations, or critical patient health needs.
Eligibility Criteria: Manufacturers must demonstrate significant patient benefit, safety data, and lack of market alternatives.
Shared Responsibility: The ANSM, manufacturer, and practitioner oversee exempted device use and can revoke approvals if safety risks arise.
Application Process:
Individual or global exemption requests submitted to ANSM.
ANSM evaluates requests and communicates decisions to operators and healthcare professionals.
Approved devices must be used under specified conditions, with patient informed consent required.
This exemption pathway ensures patient access to essential medical devices while maintaining safety and regulatory oversight.

Region: European Union
Source: https://ansm.sante.fr/documents/reference/dispositifs-medicaux-en-acces-derogatoire-derogations-globales