Regulatory Open Forum

 Wanted to understand the responsibilities and legal obligations of the importer / UKRP/ service and maintenance provider ( all three are assumed by one entity) if there are unauthorized device modifications in the field.

From the guide attached ,section 3.4 "In specific cases, where it is deemed that using an alternative accessory to that specified by the device manufacturer would give improved benefits, then a risk assessment should be carried out to ensure that all components within a system are compatible and can be used safely, e.g. batteries, chargers, connectors" , it seems certain modifications for accessories or components are allowed provided there is a risk assessment , if yes, who owns this responsibility ?

Any views on this, please comment.

Thanks

Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively.  But generally, when an economic operator like an importer or any other person (such as a healthcare organization) independently performs manufacturing operations like modifying the subject device, then such operator automatically becomes the responsible manufacturer for that device. This can put both it and the original manufacturer and the user in harm's way (regarding compliance and/or safety). Much more could be said about that, such as when a third party service/maintenance organization specifically contracted by the manufacturer to perform the servicing/maintenance deviates from the manufacturer's specifications.

A different scenario is when the healthcare organization uses an unauthorized "accessory" (i.e., a true "accessory" as legislatively defined) with the subject device.  Such a scenario constitutes misuse and is the responsibility of the original manufacturer. The ultimate impact of that misuse is to be assessed and resolved commensurate with risk, up to and including FSCA. Yet this is limited by the manufacturer's awareness of the issue. If the manufacturer isn't aware that a healthcare organization did not follow the manufacturer's instructions, then there is generally no obligation for the manufacturer to react to the misuse. In contrast, if for example, the manufacturer is aware of the use of unauthorized accessories, then the manufacture is required to react accordingly commensurate with risk.

 Wanted to understand the responsibilities and legal obligations of the importer / UKRP/ service and maintenance provider ( all three are assumed by one entity) if there are unauthorized device modifications in the field.

From the guide attached ,section 3.4 "In specific cases, where it is deemed that using an alternative accessory to that specified by the device manufacturer would give improved benefits, then a risk assessment should be carried out to ensure that all components within a system are compatible and can be used safely, e.g. batteries, chargers, connectors" , it seems certain modifications for accessories or components are allowed provided there is a risk assessment , if yes, who owns this responsibility ?

Any views on this, please comment.

Thanks

Hi Kevin,

Thanks for your response, UK conformity was based on MDD.

Original Message:
Sent: 26-Apr-2024 10:37
From: Kevin Randall
Subject: Unauthorized device modification

Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively.  But generally, when an economic operator like an importer or any other person (such as a healthcare organization) independently performs manufacturing operations like modifying the subject device, then such operator automatically becomes the responsible manufacturer for that device. This can put both it and the original manufacturer and the user in harm's way (regarding compliance and/or safety). Much more could be said about that, such as when a third party service/maintenance organization specifically contracted by the manufacturer to perform the servicing/maintenance deviates from the manufacturer's specifications.

A different scenario is when the healthcare organization uses an unauthorized "accessory" (i.e., a true "accessory" as legislatively defined) with the subject device.  Such a scenario constitutes misuse and is the responsibility of the original manufacturer. The ultimate impact of that misuse is to be assessed and resolved commensurate with risk, up to and including FSCA. Yet this is limited by the manufacturer's awareness of the issue. If the manufacturer isn't aware that a healthcare organization did not follow the manufacturer's instructions, then there is generally no obligation for the manufacturer to react to the misuse. In contrast, if for example, the manufacturer is aware of the use of unauthorized accessories, then the manufacture is required to react accordingly commensurate with risk.

 Wanted to understand the responsibilities and legal obligations of the importer / UKRP/ service and maintenance provider ( all three are assumed by one entity) if there are unauthorized device modifications in the field.

From the guide attached ,section 3.4 "In specific cases, where it is deemed that using an alternative accessory to that specified by the device manufacturer would give improved benefits, then a risk assessment should be carried out to ensure that all components within a system are compatible and can be used safely, e.g. batteries, chargers, connectors" , it seems certain modifications for accessories or components are allowed provided there is a risk assessment , if yes, who owns this responsibility ?

Any views on this, please comment.

Thanks

Hello Kevin,

Could you clarify "But generally, when an economic operator like an importer or any other person (such as a healthcare organization) independently performs manufacturing operations like modifying the subject device, then such operator automatically becomes the responsible manufacturer for that device." What happens if this was the case, what does it mean? Doesn't the manufacturer need to bring back the device to its original specifications? What responsibility of the manufacturer, no longer applies?

Hi Kevin,

Thanks for your response, UK conformity was based on MDD.

Original Message:
Sent: 26-Apr-2024 10:37
From: Kevin Randall
Subject: Unauthorized device modification

Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively.  But generally, when an economic operator like an importer or any other person (such as a healthcare organization) independently performs manufacturing operations like modifying the subject device, then such operator automatically becomes the responsible manufacturer for that device. This can put both it and the original manufacturer and the user in harm's way (regarding compliance and/or safety). Much more could be said about that, such as when a third party service/maintenance organization specifically contracted by the manufacturer to perform the servicing/maintenance deviates from the manufacturer's specifications.

A different scenario is when the healthcare organization uses an unauthorized "accessory" (i.e., a true "accessory" as legislatively defined) with the subject device.  Such a scenario constitutes misuse and is the responsibility of the original manufacturer. The ultimate impact of that misuse is to be assessed and resolved commensurate with risk, up to and including FSCA. Yet this is limited by the manufacturer's awareness of the issue. If the manufacturer isn't aware that a healthcare organization did not follow the manufacturer's instructions, then there is generally no obligation for the manufacturer to react to the misuse. In contrast, if for example, the manufacturer is aware of the use of unauthorized accessories, then the manufacture is required to react accordingly commensurate with risk.

 Wanted to understand the responsibilities and legal obligations of the importer / UKRP/ service and maintenance provider ( all three are assumed by one entity) if there are unauthorized device modifications in the field.

From the guide attached ,section 3.4 "In specific cases, where it is deemed that using an alternative accessory to that specified by the device manufacturer would give improved benefits, then a risk assessment should be carried out to ensure that all components within a system are compatible and can be used safely, e.g. batteries, chargers, connectors" , it seems certain modifications for accessories or components are allowed provided there is a risk assessment , if yes, who owns this responsibility ?

Any views on this, please comment.

Thanks