There are no predefined rules in determining to what extent a manufacturer should investigate a medical device complaint, but there are several key facts and questions that may be used as a guidance.
An investigation can be divides in three main steps, according to the nature of the complaint and the potential or actual risk:
First step – Initial Investigation
1. determine whether or not all necessary information is available – if not, try to gather it
2. define the compliant – is it a probable nonconformity or is it actual?
3. review the information and the warnings provided in the instructions for use
Second Step – Examine the probable cause
When the compliant is clearly identified, this should result in two possible choices:
1. close the complaint at its early stages – as there is no need to further investigate
2. proceed examining the probable cause
The probable cause should be investigated when:
1. there is a new problem that was never previously identified
2. the assessed risk for this kind of nonconformity has been exceeded
3. the issue is well-known, but it is outside its normal trend/frequency limits (importance of gathering statistics and data)
A manufacturer should stop investigating when the nonconformity is within the limits taken into consideration based on the risk assessment, IFUs and Labels.
Third step – Inspect the root cause
After correctly assessing the probable causes, two possible choices will again remain:
1. close the complaint at the second stage
2. proceed examining the root cause
If an investigation proceeds to the next step, it may be necessary to open a CAPA and update the risk management file. In addition, it may also be necessary to investigate whether a recall of the devices is needed. In general, an investigation should only proceed inspecting the root cause of the compliant when:
1. it caused or contributed to a death or serious injury (or it could have)
2. it is a violation of an applicable regulation or product specification
3. it exceeds the predefined trending limits
4. the management requests a detailed investigation
The main goal of a comprehensive investigation should always be to sharethe outcome internally to improve the safety and effectiveness of your devices, thus reducing the probability of a compliant occurring again.
Additionally, external communication is also needed, represented by the following options:
1. Vigilance reports: To be submitted to the Competent Authorities – possibly under responsibility of E.A.R., if mandated.
2. Customer communication: Summary of the investigation/CAPA
Obelis at Your Service
If you wish to know more about regulatory issues under EU Law, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will answer any questions you may have and will gladly assist you in the process in safeguarding the compliance of your devices.