Lifecycle of a medical device
MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.
Overview
The EU regulatory framework under MDR and IVDR is explicitly lifecycle-based. Unlike the MDD/IVDD era, where regulatory engagement was concentrated at the point of initial market access, MDR and IVDR impose continuous, evolving obligations from first design intent through to device discontinuation and decommissioning.
Understanding the lifecycle is essential to planning compliance activity, resourcing regulatory functions, and avoiding the common failure mode of treating CE marking as the finish line rather than a milestone.
The six phases
Phase 1 — Design & Development
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Phase 2 — Pre-market (Conformity Assessment)
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Phase 3 — Market Access (CE Marking & Registration)
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Phase 4 — Post-market (PMS, Vigilance, PMCF/PMPF)
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Phase 5 — Device Changes & Lifecycle Events
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Phase 6 — Discontinuation & Decommissioning
Phase 1 — Design & development
What happens: The device concept is defined, requirements established, and the design developed and verified/validated.
Key regulatory activities:
| Activity | MDR/IVDR requirement |
|---|---|
| Establish intended purpose | Foundation of all classification and conformity decisions |
| Apply GSPR from the outset | Annex I (both regulations) — not retrospectively |
| Initiate risk management | ISO 14971 process — must start at concept phase |
| Identify applicable standards | Harmonised standards and Common Specifications |
| Plan clinical/performance evaluation strategy | MDR Art. 61 / IVDR Art. 56 — early planning required |
| Classify the device | MDR Annex VIII / IVDR Annex VIII |
| Determine conformity assessment route | Depends on classification |
| Engage notified body early (if required) | Pre-submission discussions — mandatory for Class III/IIb MDR scrutiny |
Common mistakes at this phase:
- Defining the intended purpose too broadly (triggers higher classification) or too narrowly (limits commercial use)
- Failing to begin GSPR mapping during design — retrofitting is costly
- Starting clinical evaluation planning late, making timelines unrealistic
Phase 2 — Pre-market (conformity assessment)
What happens: The manufacturer demonstrates that the device meets all applicable requirements and obtains a notified body certificate (where required).
Key regulatory activities:
| Activity | MDR/IVDR requirement |
|---|---|
| Compile Technical Documentation (Annex II & III) | Both regulations |
| Complete clinical evaluation (MDR) / performance evaluation (IVDR) | MDR Art. 61 + Annex XIV / IVDR Art. 56 + Annex XIII |
| Conduct conformity assessment with notified body (if required) | MDR Annex IX, X, or XI / IVDR Annex IX, X, or XI |
| Scrutiny procedure for high-risk MDR devices | MDR Art. 54 — Class III and certain IIb implantable devices |
| EMA consultation (if device incorporates medicinal substance) | MDR Art. 52(9) |
| Draw up EU Declaration of Conformity | MDR Annex IV / IVDR Annex IV |
| Assign UDI | MDR Art. 27 / IVDR Art. 24 |
Timeline considerations:
- Notified body timelines for new applications currently range from 12 to 36+ months depending on NB capacity and device risk class
- Class III MDR devices require the scrutiny procedure (additional ~90 days after NB assessment)
- IVDR Class C and D devices face the longest timelines due to NB capacity constraints in the transitional period
Phase 3 — Market access (CE marking & registration)
What happens: The device is CE marked, registered in EUDAMED, and placed on the EU market for the first time.
Key regulatory activities:
| Activity | MDR/IVDR requirement |
|---|---|
| Affix CE marking | MDR Art. 20 / IVDR Art. 18 |
| Register economic operators in EUDAMED (obtain SRN) | MDR Art. 30 / IVDR Art. 27 |
| Register the device in EUDAMED | MDR Art. 29 / IVDR Art. 26 |
| Upload UDI-DI data to EUDAMED | MDR Art. 28 / IVDR Art. 25 |
| Ensure labelling meets Annex I §23 requirements | Both regulations |
| Ensure IFU is available in required language(s) | MDR Annex I §23.4 |
| Establish distribution records system | Required for traceability |
Who can place the device on the market:
- EU-based manufacturer: directly
- Non-EU manufacturer: only through a designated EU REP
Phase 4 — Post-market (PMS, vigilance, PMCF/PMPF)
What happens: The device is in active use in the market. The manufacturer continuously monitors safety and performance, reports incidents, updates clinical/performance evaluation, and maintains the technical documentation.
This phase is ongoing for the entire period the device is on the market — it does not end until the device is discontinued.
Key regulatory activities:
| Activity | Applies to | Frequency |
|---|---|---|
| Post-market surveillance (PMS) — data gathering | All devices | Continuous |
| PMS Report | Class I MDR / Class A–B IVDR | As needed (upon request or significant change) |
| Periodic Safety Update Report (PSUR) | Class IIa, IIb, III MDR / Class C, D IVDR | IIa: min. every 2 years; IIb/III: annual |
| PMCF Plan & Evaluation Report update | Class IIa and above (MDR) | Defined in PMCF plan, min. annual review |
| PMPF Plan & Evaluation Report update | Class B and above (IVDR) | Defined in PMPF plan |
| Serious incident reporting | All devices | 15 days (serious), 2 days (risk to life), 30 days (trend) |
| Field safety corrective actions (FSCA) | All devices, when required | Without delay when safety issue identified |
| EUDAMED data maintenance | All devices | Ongoing, update when data changes |
| Annual safety report for Clinical Investigation | If applicable | Annual |
Phase 5 — Device changes & lifecycle events
What happens: The device or its regulatory context changes. This triggers assessment of whether the existing certification remains valid, and whether new conformity assessment is needed.
Triggers for regulatory reassessment:
| Change type | Likely regulatory impact |
|---|---|
| Design change affecting safety or performance | Update to Technical Documentation; may require NB notification or new assessment |
| New intended purpose added | May trigger reclassification; new conformity assessment |
| Change in manufacturing site or process | NB notification; QMS audit may be required |
| Supply chain change affecting conformity | QMS update; supplier qualification |
| Change in manufacturer name or address | EUDAMED update; labelling change |
| EU REP change | EUDAMED update; labelling update |
| NB certificate expiry or lapse | Recertification required before continued market supply |
| New harmonised standard published | Review for adoption; transition period managed per standard |
| Regulatory change (new MDR amendment, CS, MDCG guidance) | Impact assessment; timeline for compliance |
Manufacturers must have a documented change management process within their QMS that captures these triggers and routes them through appropriate impact assessment.
Phase 6 — Discontinuation & decommissioning
What happens: The manufacturer decides to withdraw the device from the market, or ceases to manufacture it. Regulatory obligations continue beyond the last sale date.
Key obligations on discontinuation:
| Obligation | MDR/IVDR requirement |
|---|---|
| Notify notified body of discontinuation | NB certificate management |
| Notify competent authorities where required | Specific Member State requirements may apply |
| Maintain Technical Documentation and DoC | Minimum 10 years after last device placed on market; 15 years for implantables |
| Maintain QMS records | Same retention periods |
| Continue vigilance obligations | For devices still in use in the field |
| Continue to participate in FSCAs | For implantable devices still in patients |
| Update EUDAMED | Reflect discontinuation status |
Discontinuation does not end regulatory responsibility. Manufacturers of implantable devices in particular may have ongoing vigilance and field safety obligations for years or decades after the last device was placed on the market.
The continuous nature of clinical/performance evaluation
One of the most significant shifts under MDR/IVDR from the MDD/IVDD era is that clinical evaluation (MDR) and performance evaluation (IVDR) are not one-time activities. They must be:
- Planned from the outset
- Updated throughout the device's lifecycle
- Informed by post-market data (PMCF/PMPF)
- Reviewed at defined intervals and whenever PMS data triggers a review
- Maintained in the technical documentation at all times in a current state
This creates a perpetual clinical/performance evidence cycle:
Initial clinical/performance evaluation
→ CE marking
→ PMS gathers real-world data
→ PMCF/PMPF studies conducted
→ Clinical/performance evaluation updated
→ PSUR/PMS report prepared
→ Technical documentation updated
→ NB reviews updated documentation (periodically)
→ Cycle continues
Related pages
- Regulatory framework overview
- Who needs to comply?
- Transitional provisions & timelines
- Pre-market overview
- Post-market overview
- Clinical evaluation
- Performance evaluation
- Post-market surveillance
Official references
| Reference | Description |
|---|---|
| MDR Art. 10 | General manufacturer obligations (lifecycle scope) |
| MDR Art. 61 + Annex XIV | Clinical evaluation (lifecycle requirement) |
| MDR Art. 83–86 | Post-market surveillance system |
| MDR Art. 87–92 | Vigilance system |
| IVDR Art. 56 + Annex XIII | Performance evaluation |
| IVDR Art. 78–82 | PMS and PMPF |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices |
| MDCG 2022-21 | Guidance on PSUR requirements |