European medical regulating authority, the EC, recently published a new guidance on medical device vigilance systems covering issues related to the distribution of information between national competent authorities. The document, intended to clarify definitions, set forth the form of Manufacturer’s Incident Report and describes the difference between particular information exchange systems – EU NCAR and IMDRF NCAR
Clarification of Definition
To simplify the use of applicable regulations and make them understandable for all parties involved, the guidance contains detailed definitions.
National Competent Authority Report (NCAR) – information on particular issue disseminated between National Competent Authorities (CA, national regulating authorities conducting marketing approval of medical devices, supervision, and regulation of medical device circulation on the local market).
Field Safety Corrective Action (FSCA) states for an action conducted by manufacturer to reduce risks associated with the use of a particular medical device. It covers all issues related to the devices being present at the market that could bear risk of causing serious harm to the health of patients.
Field Safety Notice (FSN), described as a special form used by medical device manufacturers to communicate with customers and users about issues related to the Field Safety Corrective Action.
According to the guidance, such actions may include the following:
- Return of a medical device to the supplier (when manufacturers decides to revoke the devices)
- Request for additional examination of the device by the customer
- Modification by manufacturer
- Request to retrofit the modification conducted by manufacturer
- Exchange
- Destruction
- Providing additional advice describing the use of medical device.
General Principles
FSCA has been introduced as an additional measure for preventing harm to the health of the patients caused by devices that are already present in the market. According to the guidance, if manufacturers decide to perform any corrective actions, similar actions should be performed on all markets where such devices are already present. The same rule should be applied to safety notices – they should be provided in all countries where the device is being distributed even if there were no incidents related to the device in the particular country. It is required to provide FSN with all products of such type until the reason would no longer be valid.
The guidance also contains detailed requirements applicable to the Field Safety Notice. For example, FSN should be performed in the language accepted by the national regulating authority. It is also strictly prohibited to include any advertising materials in this type of communication. At the same time, the national regulating authority may request manufacturers to revise FSN in case of any amendments needed.
Cooperation Between Regulating Authorities
The guidance specifies two approaches for international cooperation between national regulating authorities. According to the first one, it is necessary to determine a single coordinating authority. Such an approach could be used in case of any concerns regarding incidents, the actions performed by manufacturers, or when the broader opinion or coordination is needed. It can also be applied in the case where the manufacturer is a foreign company, so the engagement of the national regulating authority of that country would improve the process and information exchange.
The second approach provides dissemination of information between several regulating authorities. It could be applied in the case where a manufacturer has already performed FSCA in an order set forth by applicable regulations, or when certain regulating authorities request manufacturers to perform such actions to improve them. Another reason for the dissemination of information could be if a manufacturer fails to submit a final report in time.
