What is in the additional guidance document?:
- Updates to the definitions of FSCA’s and FSN’S;
- Clarification on the section regarding FSCA’s – i.e. for instances where a device is introduced into a new market after the implementation of an FSN, there is now a recommendation to review whether the risk cited in an FSN remains relevant. This section also recommends that the manufacturer should only exclude a country from FSN distribution if they a robust and objective rationale for its exclusion
- References to availability of the following on the EU Commission website – FSCA template, FSN template, Customer reply, and distributor reply form.
- Provision of further detail in relation to the area of the coordination of Vigilance issues amongst Competent Authorities and for more complex issues, the requirement of a Vigilance task force.
- Clarification on the differences between the EU NCAR exchange and the IMDRF NCAR exchange.
- Details on IMDRF and NCAR exchange
- Reference to availability of the European NCAR form and instructions for completion on the EU Commission website
- Reference to availability of the IMDRF NCAR form and the instructions to complete on the EU Commission website