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Compliance research
An MDR representative change needs a controlled handover, rather than just a new appointment. Article 12 identifies mandate dates, use of the outgoing representative’s details, document transfer and continued forwarding of suspected-incident reports. Turn those into four named handoff records before agreeing the change.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · EU
| Decision or task | What the source describes | What to prepare |
|---|---|---|
| How do the mandates join? | Article 12(a) requires the agreement to address the outgoing mandate’s termination date and the incoming mandate’s beginning date. [1] | Prepare a dated handover schedule identifying the manufacturer, outgoing/incoming parties and covered device groups. Have the parties resolve coverage and dates rather than assuming the new signature ends the old mandate. |
| When do old representative details stop being used? | Article 12(b) addresses the date until which the outgoing representative may be indicated in manufacturer-supplied information, including promotional material. [1] | Inventory affected labels, IFUs, websites and promotional files, then assign the agreed cutoff and change owner for each. The provision does not supply a universal sell-through period. |
| Can the incoming party actually retrieve the records? | Article 12(c) addresses transfer of documents, including confidentiality and property rights. [1] | Reconcile the document index with an acknowledged transfer: approved versions, missing files, access permissions and confidentiality/property restrictions. Test retrieval of representative examples before declaring the handoff complete. |
| Where do late incident messages go? | Article 12(d) addresses forwarding, after the old mandate ends, complaints or suspected-incident reports from healthcare professionals, patients or users for devices covered by that mandate. [1] | Agree monitored channels and named forwarding recipients, and test an example late message. Keep this forwarding task distinct from the manufacturer’s incident assessment and reporting work. |
MDR Article 12 is the source of this handover checklist. IVDs and other product regimes need their own provisions. The guide does not set a universal transition period, terminate a mandate or decide stock, liability or reporting questions for the buyer.
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Prepare a dated handover schedule identifying the manufacturer, outgoing/incoming parties and covered device groups. Have the parties resolve coverage and dates rather than assuming the new signature ends the old mandate.
Useful evidence: Mandates, device-group coverage and a signed change/date schedule.
Inventory affected labels, IFUs, websites and promotional files, then assign the agreed cutoff and change owner for each. The provision does not supply a universal sell-through period.
Useful evidence: An affected-information inventory with agreed dates, version owners and unresolved stock questions.
Reconcile the document index with an acknowledged transfer: approved versions, missing files, access permissions and confidentiality/property restrictions. Test retrieval of representative examples before declaring the handoff complete.
Useful evidence: Document/version index, transfer acknowledgements, access tests and rights/confidentiality record.
Agree monitored channels and named forwarding recipients, and test an example late message. Keep this forwarding task distinct from the manufacturer’s incident assessment and reporting work.
Useful evidence: A post-termination forwarding agreement, monitored-channel list and escalation test record.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
Thu, 10 Sep 2026 17:31:54 GMT · retrieved 2026-10-06
Source key D05 · snapshot fd42f74592a6a3ac614be3505c16b24acc814c725637749534fcbff0c5d411d6
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