All three European medical device directives include requirements for manufacturers or their Authorised Representatives to institute and maintain a systematic review of experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. This also includes an obligation for the manufacturer to notify the relevant Competent Authorities when learning of adverse incidents associated with the use of its devices.
Guidance has been issued by the European Commission, last updated in January 2013, further detailing under what circumstances such notification is expected, and in what format it should be provided.
In addition, the Directives expect manufacturers to conduct regular reviews of the clinical data held on file, to ebsure it is up-to-date and includes the latest clinical safety and performance data.
GEMAR can help you decide whether you are legally obligated to report particular post-market events to the relevant Competent Authorities, and if so, how to prepare and submit the required reports. We can also assist in developing post-market surveillance (PMS) standard operating procedures (SOPs) or help with regular device PMS reviews - contact us for further information.