Mock recall in medical devices

There is no direct requirement regarding the mock recall in both ISO 9001 and ISO 13485. In ISO 13485:2016 recall is covered under the requirement 8.2.3 Reporting to regulatory authorities. There it is said that complaints that can have unacceptable risks to the health or safety of patients must be reported to the competent authority in accordance with the applicable regulatory requirements.

In Medical device regulation MDR 2017/745, Article 95 Procedure for dealing with devices presenting an unacceptable risk to health and safety is also stated that recall is necessary and describe the process of recall.

Fortunately, recall is a rare situation with most manufacturers. That is why it is logical to do a recall simulation from time to time to make sure that the entire traceability process and the recall are under control.

The requirement that the manufacturer must have its processes under control is specified in 4.1 General requirements.