EU: European Commission guidance on medical device vigilance requirements

The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD).

The “Additional Guidance Regarding the Vigilance System” augments issues as outlined in MEDDEV 2.12-1 rev. 8, including Manufacturer’s Incident Reports (MIR), field safety actions and notices, and device-specific vigilance reporting recommendations.

The guidance clarifies a few existing definitions for FSCA (Field Safety Corrective Action) and FSN (Field Safety Notice) and states that manufacturers should initiate FSCAs in all markets in which devices in question are commercialized.

Furthermore, the guidance introduces several new documents such as a new Field Safety Notice template.

• The guidance can be downloaded here: Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8.
• MEDDEV 2.12-1 Rev.8 here: MDCG guidance documents.

Other topics:

• EU: European Commission guidance on medical device vigilance requirements
• MEDCERT successfully re-designated according to MDD and AIMDD
• ATTENTION: fake certificate
• EU: European Commission names UDI Issuing Agencies
• EU: guidance on use of symbols for the MDR
• USA: MEDCERT at the RAPS Regulatory Convergence in Philadelphia
• MEDCERT: important information on your MDD and AIMDD certificates