How to report a Field Safety Corrective Action
Manufacturers are required to report field safety corrective actions to the authorities using the common European reporting form, Field Safety Corrective Action - FSCA
What should the report contain?
The report on field safety corrective actions should include all necessary information for the authorities to assess and monitor the actions as they are implemented. The information should cover:
Background information and reasons for initiating the FSCA
Relevant parts of the risk analysis
Description and explanation of the safety corrective actions
Guidance on the actions to be taken by the dealer or user
Details of the affected medical device (such as catalog, serial, or lot numbers)
Contact information for the manufacturer and any authorized representative
A copy of the Field Safety Notice (FSN)
What should the safety notice contain?
In Norway, safety notices should be in Norwegian, but an English version may be accepted until a Norwegian translation is available. The notice should be understandable to the recipient who will carry out the action on behalf of the manufacturer. Safety notices should include:
Relevant Unique Device Identifier (UDI)
Single Registration Number (SRN)
Manufacturer's reference number for the measure.
Clear information about the safety corrective action, including:
Risk profile concerning patients, users, or others
Reason for the msafety corrective action and how it is related to the medical device
Clear and concise instructions on what users must do regarding the safety notice and the medical device
When reporting a corrective safety measure to the authorities, the FSCA report and the Norwegian safety notice must be attached at a minimum.
Both the PDF and XML versions of the FSCA report must be attached.
The report on the field safety corrective action and the safety notice for medical device in the Norwegian market or from Norwegian manufacturers should be sent to the Norwegian Medicines Agency (Legemiddelverket) via email (External Link).
Upon submitting the preliminary report, the Norwegian Medicines Agency will respond with a case number. This number should be clearly stated in all subsequent communications.
If there are decisions about changes/extensions to the safety correctrive action, the Norwegian Medicines Agency must receive a follow-up report and an updated safety notice where applicable. The updated safety notice should be distributed to users/owners.
Once the field safety corrective action is completed, a final report summarizing the actions taken with reconcilliation data should be sent to the Norwegian Medicines Agency.
Overview of the different roles of economic operators:
Definition in MDR Article 2 and IVDR Article 2
|Manufacturer||A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.|
|Authorised representative||Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.|
|Importer||Any natural or legal person established within the Union* that places a device from a third country on the Union* market.|
|Distributor||Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.|
|Health institution||An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.|