EU MDR & IVDR Transition
Legacy devices placed on the market under MDD, AIMDD or IVDD certificates must move to the MDR or IVDR within extended, conditional transition periods. We run the transition as a governed programme, from portfolio decisions to certification.
Three situations we see most
Legacy MDD and AIMDD devices
Devices relying on legacy certificates and the extended MDR transition periods, with Notified Body agreements to honour.
IVDs entering Notified Body review
Many devices self-certified under the IVDD now need a Notified Body under the IVDR, often for the first time.
Portfolio rationalisation
Deciding which products to transition, combine or withdraw, based on revenue, evidence gaps and certification cost.
Extended deadlines, with conditions
Extended periods apply only where conditions are met, including a QMS in place and a Notified Body application and written agreement by set dates. Several of those dates have passed, so eligibility must be confirmed device by device.
- Since 10 January 2025, manufacturers must also give advance notice of supply interruptions that could cause serious harm (Article 10a, MDR and IVDR).
| Regulation | Devices | Transition ends |
|---|---|---|
| MDR | Class III and Class IIb implantable devices, with listed exceptions | 31 Dec 2027 |
| MDR | Other Class IIb, Class IIa, and Class I devices needing a Notified Body | 31 Dec 2028 |
| IVDR | Class D | 31 Dec 2027 |
| IVDR | Class C | 31 Dec 2028 |
| IVDR | Class B and sterile Class A | 31 Dec 2029 |
Moving a whole portfolio, not just one file
Two parallel streams: the quality system first, then each product file under the updated procedures.
- Programme01
Programme set-up
Steering committee, charter, core team, plans, communication and status reporting.
- Portfolio02
Portfolio assessment
Review every product for impact, classification, grouping and rationalisation.
- QMS stream03
QMS gap assessment
Assess the QMS against MDR or IVDR, prioritise gaps by risk and complexity, assign process owners.
- QMS stream04
QMS update
Revise procedures and templates so all remediation follows the new process.
- Product stream05
Product gap assessment
Assess each technical file against the checklist and prioritise gaps, such as testing or clinical data generation.
- Product stream06
Product remediation
Close the gaps using the updated procedures, templates and current state of the art.
- Certification07
Submission preparation
Compile the updated documentation into the technical documentation template for review.
- Certification08
Conformity assessment
Notified Body liaison, query responses and certification under the new regulation.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.