Clinical evaluation · lifecycle maintenance
How often should the Clinical Evaluation Report be updated?
The MDR requires the clinical evaluation to remain current, but it does not impose one CER revision interval for every device. The right approach combines scheduled reviews with clearly defined update triggers.
Understand the update logic ↓Document the review↻Clinical impact
Revise the CER
Continuous inputs · justified revision decision
The short answer
Review on a defined schedule, revise when the evidence requires it
PMCF supplies new clinical evidence, but it does not replace the CER. Every review needs a documented conclusion, even when the manufacturer determines that a formal CER revision is unnecessary.
01
What does the MDR require? #
Article 61(11) of the MDR ↗ states that the clinical evaluation and its documentation must be updated throughout the lifecycle of the device using clinical data obtained from the manufacturer’s PMCF and Post-Market Surveillance activities.
The results of the clinical evaluation and the supporting clinical evidence are documented in the CER. Consequently, keeping the clinical evaluation current also means ensuring that the CER continues to reflect the available evidence and the manufacturer’s current conclusions.
The MDR does not require manufacturers to rewrite the CER whenever an individual item of clinical information becomes available. However, the manufacturer must have a controlled process for reviewing new information and determining whether it requires a formal CER revision.
The obligation is to maintain a current clinical evaluation throughout the device lifecycle, not merely to revise a document on a calendar date.
02
What does MEDDEV 2.7/1 recommend? #
MEDDEV 2.7/1 revision 4 ↗ remains a useful methodological reference for clinical evaluation, although it was developed under the former Medical Device Directives rather than the MDR.
The guidance states that manufacturers should define and justify the frequency of clinical evaluation updates. An update should be performed when new information from PMS may affect the clinical evaluation or when the device has been modified in a way that could influence its clinical safety or performance.
Where no specific trigger has been identified, MEDDEV 2.7/1 recommends the following intervals:
Devices presenting significant risks or devices that are not yet well established
Well-established devices without significant risks, where the interval is justified
These intervals are useful reference points, but they are not fixed MDR deadlines. The appropriate frequency should be determined for the individual device.
03
Does PMCF replace CER updates? #
No. PMCF and the CER have different but closely connected functions.
PMCF is a continuous process through which the manufacturer proactively collects and evaluates clinical data from the use of a CE-marked device. Its purpose is to confirm safety and performance throughout the expected lifetime of the device, verify the continued acceptability of identified risks and detect emerging risks.
The findings are documented in a PMCF evaluation report. Under Annex XIV, Part B of the MDR, this report forms part of the CER and the technical documentation. Its conclusions must also be taken into account in the clinical evaluation and risk-management process.
PMCF therefore provides evidence that keeps the clinical evaluation current. It does not replace the CER or remove the need to review and revise it.
Collect and evaluate post-market clinical data
Documents findings and conclusions
Reflects relevant evidence and conclusions
04
Must the CER be revised after every PMCF activity? #
Not necessarily.
The manufacturer may maintain the PMCF evaluation report as a separate controlled document referenced by the CER. A new CER revision is not automatically required whenever a survey is completed, a new complaint is received or another individual item of clinical information becomes available.
The new information must nevertheless be reviewed. If it affects, or could reasonably affect, the clinical evaluation, the CER should be updated.
Even when the manufacturer concludes that no CER revision is necessary, the review and its conclusion should be documented. This provides evidence that the clinical evaluation has been actively maintained rather than simply left unchanged.
05
What can trigger a CER update? #
A CER should be revised when new information materially affects its content, analysis or conclusions. Relevant triggers may include:
- New findings from PMCF activities
- New PMS or vigilance information
- Previously unknown or changing adverse-event trends
- Changes in known undesirable side effects
- New clinical investigations or device-specific data
- New or revised scientific literature
- Changes in the clinical state of the art
- New treatments, technologies or alternative devices
- Changes to intended purpose or target population
- New or modified clinical claims
- Clinically relevant design, software or manufacturing changes
- Changes to risk-management conclusions
- New clinical evidence gaps
- New specifications, standards or regulatory expectations
- Findings raised by a Notified Body or authority
The decision should be based on the clinical significance of the information, not merely on whether a predefined calendar date has been reached.
06
How should the review frequency be determined? #
The manufacturer should establish and justify a risk-based review frequency in the clinical evaluation procedure or another appropriate QMS document.
The justification should consider factors such as:
- Device classification
- Nature and severity of associated risks
- Novelty of the technology or clinical application
- Maturity and quality of the clinical evidence
- Length of market experience
- Expected lifetime of the device
- Number of devices placed on the market
- Rate of technological and clinical change
- PMS and vigilance findings
- PMCF methods and reporting schedule
- Outstanding clinical evidence gaps
- Stability of the benefit-risk profile
- Applicable conformity-assessment requirements
A stable, well-established, lower-risk device with extensive clinical experience may justify a longer interval between complete CER revisions. A novel, higher-risk device or a device with limited clinical evidence will normally require more frequent review and updating.
07
What applies to Class III and implantable devices? #
For Class III and implantable devices, Article 61(11) of the MDR requires the PMCF evaluation report to be updated at least annually. Where applicable, the Summary of Safety and Clinical Performance must also be updated annually.
The provision does not expressly state that every CER for a Class III or implantable device must undergo a complete formal revision every year. Nevertheless, the annual PMCF evaluation must be considered within the clinical evaluation.
In practice, the clinical evaluation should therefore be reviewed alongside the annual PMCF evaluation report. A new CER revision should be issued when the annual review identifies information that affects the clinical evaluation, its conclusions or the consistency of the technical documentation.
The manufacturer’s document structure and QMS procedure should make the relationship between the CER and annual PMCF evaluation report clear.
08
Should the Clinical Evaluation Plan also be updated? #
The Clinical Evaluation Plan should remain aligned with the device, its clinical evidence strategy and the identified evidence gaps.
It does not necessarily require revision every time the CER is reviewed. However, it should be updated when the clinical evaluation strategy changes, including when:
- New clinical questions or evidence gaps are identified
- The intended purpose or clinical claims change
- New PMCF activities are required
- The state of the art changes materially
- Existing methods are no longer adequate
- New safety or performance concerns need to be investigated
The CEP, CER, PMCF plan, PMCF evaluation report, PMS documentation and risk-management file should remain consistent with one another.
09
A practical approach to CER maintenance #
A practical QMS procedure should combine scheduled reviews with event-driven update triggers.
At each scheduled review, the manufacturer should assess new information from PMS and vigilance, PMCF activities, complaints and trend reporting, scientific literature, state-of-the-art surveillance, risk management, device changes and regulatory monitoring.
No relevant clinical impact
Document the review, its evidence base and the justification for retaining the current CER revision.
Actual or potential clinical impact
Update the CER and align the related clinical, PMS, PMCF and risk-management documentation.
This approach avoids unnecessary rewriting while ensuring that the CER remains a current and reliable part of the technical documentation.
Conclusion
PMCF keeps the evidence moving; the CER keeps the evaluation integrated
PMCF does not make CER updates redundant. It generates and evaluates the post-market clinical evidence needed to keep the clinical evaluation current.
The MDR does not prescribe one universal CER update interval. Manufacturers should establish a justified, risk-based review frequency and define clear triggers for earlier updates.
For stable and well-established devices, a longer interval between full CER revisions may be justified. However, PMS, PMCF and literature surveillance must continue throughout that interval. Whenever new information affects the clinical evidence, state of the art, benefit-risk determination, clinical claims or safety and performance conclusions, the CER should be revised without waiting for the next scheduled update.
Clinical evaluation lifecycle
Need a defensible CER review and update strategy?
Discuss your clinical evaluation ↗From the knowledge centre
