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Customer Returns
Customer Returns Testing and Analysis
Are product complaints diverting man power and consuming resources you'd rather spend elsewhere?
Customer returns are an inevitable part of the business, but they need not be an integral part of yours!
Our unique First Line QA service makes it easy to comply with the EU MEDDEV 2.12-1 Rev 5 "Guidelines on a medical devices vigilance system" stipulating that "any manufacturer selling on the European market should make sure that their vigilance systems are updated to meet the revised guidance" (MHRA). These guidelines apply to:
- CE marked medical devices.
- Custom-made medical devices.
- Medical devices whose availability precedes CE marking.
- Other items where an incident occurs leading to corrective action on devices included above.
MET's specialist and confidential service provides an effective and simple way of facilitating the management of your product complaints within the UK, leaving you free to concentrate on your value-added activities. It is designed around a structured and time-sensitive processing of your returns. By conducting the original investigation and feeding data back to you rapidly, we enable you to provide a fast response to your end-users and react to technical failures early on. This service can be tailored to your exact requirements and includes:
- Decontamination
- Checks against specifications
- Physical diagnostic
- Compliance with standards
- Independent reports
- Archiving
First Line QA is as simple as 1, 2, 3...
- Your marketing system diverts returned products and complaints to us.
- We analyse the complaint, decontaminate any product and bench test against your specifications
- You receive an independent report of the product's performance and a quarterly or monthly summary of complaints and trends
We will classify the complaints according to the new vigilance terminology, notify the Competent Authority (if you have requested this), report our results to you (within agreed timescales), and provide a periodic summary reports with trend analysis and recommendations.
The new guidance gives deadlines for reporting incidents:
| Type of Incident | Required Reporting Period |
|---|---|
| Serious public health threat | Immediate, which means within 2 calendar days of the manufacturer becoming aware of a threat. |
| Death or unanticipated serious deterioration in state of health | Immediately after the manufacturer establishes a link between the event and the device, in any case within a maximum of 10 days of the manufacturer becoming aware of the threat. |
| Other incidents | Immediately after the manufacturer establishes a link between the event and the device, in any case within a maximum of 30 days of the manufacturer becoming aware of the threat. |
The new guidance also has some new definitions:
| New Term | Definition |
|---|---|
| Abnormal use | An act or omission of an act by a user of a medical device as a result of conduct that is beyond any means of risk control by the manufacturer. |
| Field Safety Corrective Action (FSCA) | An action taken by a manufacturer to reduce the risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market; these actions should be notified via a Field Safety Notice. |
| Field Safety Notice (FSN) | A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action. |
| Indirect Harm | Some diagnostic devices and all IVDs do not act directly on the individual. Harm may occur as a consequence of the medical decision, action taken/not taken on the basis of information or result(s) provided by the device. |
| Periodic Summary Reporting | An alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the same device or device type in a consolidated way, where the root cause in known or an FSCA has been implemented. |
| Trend Reporting | A reporting type used by a manufacturer when a significant increase in events not normally considered incidents according to section 5.1.3 occurred and for which predefined trigger levels are used to determine the threshold for reporting. |
| Unanticipated | A deterioration in state of health is considered unanticipated if the condition leading to the event was not considered in a risk analysis. |
| User Error | An act or omission of an act, that has a different result to that intended by the manufacturer or expected by the operator of the medical device. |
