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Notice to applicants for marketing for Temporary Authorisation for Use (ATU) (05/08/2015) application/pdf
Application of the Regulation (EU) on clinical trials on medicinal products: ANSM to implement a pilot phase - Information update (14/04/2015) application/pdf
Temporary Specialist Scientific Committee on inhibitors of the FAAH (Fatty Acid Amide Hydrolase)- 03/31/2016 - Summary of conclusion (06/04/2016) application/pdf
Report by the Temporary Specialist Scientific Committee (TSSC), "FAAH (Fatty Acid Amide Hydrolase)", on the causes of the accident during a Phase 1 clinical trial in Rennes in January 2016 (25/04/2016) application/pdf
Implantable defibrillation leads - Inspection campaign summary report (19/05/2016) application/pdf
Enforcement of the european regulation on clinical trials on medicinal products : assesment six months into the pilot phase - Information bulletin (19/04/2016) application/pdf
Decision of 10/09/2015 setting out the specific conditions for the placing on the market and distribution of certain medical devices sterilised using ethylene oxide - Framework and implementation modalities (19/02/2016) application/pdf
Temporary Specialist Scientific Committee on inhibitors of the FAAH (Fatty Acid Amide Hydrolase) - Summary of conclusion (17/02/2016) application/pdf
Study on safety of medical devices software (13/07/2016) application/pdf
Situation report on the active substance amoxicillin (26/09/2016) application/pdf
Temporary Specialist Scientific Commity "Breast implant biocompatibility evaluation strategy" - 02/01/2016 -Meeting minutes (06/07/2016) application/pdf
Temporary Specialist Scientific Commity "Breast implant biocompatibility evaluation strategy" - 03/15/2016 -Meeting minutes (06/07/2016) application/pdf
Guideline for demonstrating textured breast implant biocompatibility (06/07/2016) application/pdf
Labelling relative to phthalates in a medical device - Notice to manufacturers (11/10/2016) application/pdf
Market surveillance of PVC medical devices presented DEHP-free - Report (11/10/2016) application/pdf
Toxicological evaluation of nanoparticle medicinal products (V2-04/11) - Recommendations (17/11/2008) application/pdf
Summary of the characteristics of a device (MD or IVD) (19/05/2009) application/msword
Notice for sponsors - The installation and control in France of clinical trials relating to medical devices and in vitro diagnostic medical devices (19/03/2008) application/pdf
Denotification or termination of notified bodies’ activities - Information (14/11/2016) application/pdf
Enforcement of the European regulation on clinical trials on medicinal products : assessment one year into the pilot phase (25/01/2017) application/pdf
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