Legacy Infusion Pump and Article 120: Can We Keep Shipping?

Not on the facts as stated. Article 120(3) MDR, as amended by Regulation (EU) 2023/607, extends the transitional period only if conditions are met. The device must be covered by a valid MDD certificate; the manufacturer must have lodged an MDR application with a notified body before 26 May 2024; and the notified body and manufacturer must have signed a written agreement by 26 September 2024. The manufacturer must also have an MDR-compliant QMS, a PRRC, and the device must continue to comply with the MDD. The extension dates are 31 December 2027 for Class III and Class IIb implantable devices (with limited exceptions) and 31 December 2028 for other Class IIb and lower-risk devices. MediFlow has not lodged an application and has no agreement. It cannot rely on the transitional provisions. If it files immediately, it may still meet the 26 May 2024 lodgement date, but the 26 September 2024 agreement deadline is tight. The notified body should verify the application receipt and the agreement, not merely the MDD certificate.

The manufacturer should immediately select a notified body and lodge a complete MDR application before 26 May 2024. It must also ensure that the QMS is MDR-compliant, the technical documentation is upgraded to Annex II/III, the clinical evaluation is updated, the PMS/PMCF plan is in place, and the PRRC is formally appointed. The application should include the MDD certificate, the declaration of conformity, the UDI-DI, and the classification rationale. The manufacturer should not wait for the new notified body to finish negotiations; the lodgement date is the critical evidence. If the application is lodged but the written agreement is not signed by 26 September 2024, the extension is lost. The notified body should require a project plan with milestones and evidence of the lodgement. EUDAMED registration and UDI assignment should also be completed before the deadline.

The battery supplier change is not automatically 'minor'. Under MDCG 2022-6, a change is significant if it affects the device's safety or performance, or if it alters the risk profile. A new battery supplier can affect charging behaviour, thermal runaway risk, and reliability. The manufacturer must perform a change impact assessment, update the risk management file, and verify the battery's suitability. If the change is significant, the device no longer benefits from the transitional provision and would need MDR certification. The notified body should require the assessment before the change is implemented. For EUDAMED, legacy devices must be registered; the manufacturer must ensure the Basic UDI-DI, UDI-DI, and label carrier are correct. The UDI must be on the label and packaging. The manufacturer should also check the EUDAMED actor registration and the device registration data against the MDD certificate.