PMS Plan
Post-market surveillance template
PMS Plan for MDR/IVDR PMS and PMCF
Use this editable PMS Plan to collect, analyse and report post-market data in a way that satisfies PMS Plan, PMCF and PSUR requirements under Regulation (EU) 2017/745.
- Best for: PMS plans, PMCF evaluation, PSUR preparation, vigilance reporting and trend analysis.
- Includes: editable sections for data collection, analysis methods, conclusions and action tracking.
- Format: editable template available through the standard WooCommerce download flow.
Lexqara supports medical device manufacturers in building proactive post-market surveillance systems that keep clinical evidence current. Explore the Resource Center or review our Post-Market Surveillance Services.
Description:
This PMS Plan defines how we will proactively and systematically collect, analyse, and act on post-market data for devices in scope.
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Define the PMS Scope (device range and data collection period)
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Ensure compliance with MDR Article 84 and Annex XIV, aligned with MDCG 2022-21
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Capture manufacturer, Authorised Representative, Notified Body, and competent authority PMS details
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Document device regulatory status in Europe, including Basic UDI-DI / EUDAMED DI and market/FSCA status
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Specify labelling essentials: Intended purpose, Indications, Contra-indications, Target populations
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Set risk-based threshold values and indicators linked to ISO 14971 risk management files
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Define trend analysis rules (including significance triggers) and escalation via MDR Article 88
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Plan PMS activities and outputs feeding PMS Report / PSUR and the wider technical documentation
Your needs:
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Post-market surveillance plan
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Post-market surveillance plan for MDR decision-making
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Reduce audit risk, strengthen benefit-risk control, and speed up PSUR readiness
This document is used to plan and govern PMS across the full device lifecycle, including data sources, responsibilities, and reporting cadence under MDR Article 84 and Annex XIV.
It covers the key PMS requirements end-to-end. Threshold values are predefined risk-based limits used to judge when post-market signals may affect benefit-risk; they matter because they trigger justified escalation. Trend reporting is the structured detection and evaluation of statistically relevant increases; it matters because it can drive CAPA and competent authority notifications.
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Define incident capture for serious and non-serious events using IMDRF coding
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Document FSCA and CAPA tracking and reconciliation versus prior periods
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Ensure PMCF interfaces via the PMCF plan and evaluation reporting
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Define literature, public database, registry, and similar-device monitoring expectations
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Specify PSUR/PMS report frequency and integration into RMF, CER, and Annex III technical documentation
At Lexqara, we tailor your PMS Plan to your device portfolio, verify the MDR logic for grouping and reporting, and help you implement practical PMS/PMCF workflows that stand up in audits. Access templates in our Resource Center and see our Post-Market Activities support. For the legal baseline, use EU MDR (Regulation (EU) 2017/745). Download the template or request a short gap assessment.
A strong PMS Plan also clarifies timelines (collection, analysis, submission), ensures consistent data granularity by device/model, and prevents gaps between complaints handling, risk management updates, and clinical documentation updates.
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Template preview: PMS Plan
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PMS Plan
For
[Device Name]
Manufacturer Name: [Manufacturer name]
Document Number: XXXX
Revision: XXXX
Approval
Reviewer
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Name: |
Date: |
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Title: |
Signature: |
Approver
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Name: |
Date: |
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Title: |
Signature: |
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Name: |
Date: |
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Title: |
Signature: |
Revision history
Table 1: History of revisions
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Revision |
Revision date |
Description of change |
Revised by |
|---|---|---|---|
Table of Contents
3. Medical devices information 6
3.1. General device information 6
3.2.1. Leading device: [Device Name 1] 6
4. Risk management, threshold values and trends 8
4.1. Threshold values and indicators 8
5. Equivalent / similar devices 10
Appendix I – Devices in scope of PMS plan 18
Scope
The PMS plan covers the following device range(s): [Device name 1], [Device name 2], hereafter named under [device short name].
The PMS plan covers the period from DD Month YYYY to DD Month YYYY.
This PMS plan has been defined in compliance with Article 84 and Annex XIV of the (EU) 2017/745 (MDR) as well as the guidance document MDCG 2022-21.
PMS general details
The following table includes the general details related to PMS activities.
Table 2: PMS general information
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1 |
Manufacturer information |
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a |
Manufacturer SRN: XXX |
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b |
Manufacturer organization name: XXX |
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c |
Contact’s first name: XXX |
e |
Contact’s last name: XXX |
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d |
Email: XXX |
f |
Phone: XXX |
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g |
Country: XXX |
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h |
Street: XXX |
i |
Street number: XXX |
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j |
Address complement: XXX |
k |
PO box: XXX |
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l |
City name: XXX |
m |
Postal code: XXX |
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2 |
Authorized representative information |
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a |
SRN: XXX |
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b |
Authorized representative organization name: XXX |
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c |
Contact’s first name: XXX |
e |
Contact’s last name: XXX |
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d |
Email: XXX |
f |
Phone: XXX |
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g |
Country: XXX |
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|
h |
Street: XXX |
i |
Street number: XXX |
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j |
Address complement: XXX |
k |
PO box: XXX |
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l |
City name: XXX |
m |
Postal code: XXX |
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3 |
Corresponding competent authority |
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a |
Name of National Competent Authority (NCA): XXX |
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b |
EUDAMED number of NCA: XXX |
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4 |
Notified Body |
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a |
NB organization name: XXX NB number: XXX |
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b |
Email: XXX |
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5 |
Medical device information |
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a |
Leading device Basic UDI-DI / Eudamed DI(s): XXX |
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b |
Other Basic UDI-DI(s) / Eudamed DI(s): XXX (See Appendix I) /OR See below |
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c |
For each Basic UDI-DI / Eudamed DI, NB number and Certificate ID(s): XXX (See Appendix I) / OR
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Medical devices information
General device information
General regulatory information of devices covered by the PMS plan are described in Appendix I – Devices in scope of PMS plan.
The following table summarizes the marketing and regulatory status of devices in Europe.
Table 3: Device status in Europe
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Trade Name |
Class |
EU regulatory history (Date) |
Status |
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First DoC |
First EU/EC certificate |
Marketed in EU? |
FSCA? |
||
|
Leading device |
|||||
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[Device Name 1] |
XX |
DD-Mon-YYYY / not yet commercialized |
DD-Mon-YYYY / not yet commercialized |
on the market / no longer placed on the market / not yet commercialized |
No ongoing FSCA / Recalled / field safety corrective action |
|
Other devices |
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[Device Name 2] |
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[Device Name 3] |
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[Device Name 4] |
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[Device Name 5] |
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Labelling information
Leading device: [Device Name 1]
Intended purpose
Indicate the information as reported in the IFU
Indications for use
Indicate the information as reported in the IFU
Contra-indications
Indicate the information as reported in the IFU
Target populations
Indicate the information as reported in the IFU
[Device Name 2]
Intended purpose
Indicate the information as reported in the IFU
Indications for use
Indicate the information as reported in the IFU
Contra-indications
Indicate the information as reported in the IFU
Target populations
Indicate the information as reported in the IFU
[Device Name 3]
Intended purpose
Indicate the information as reported in the IFU
Indications for use
Indicate the information as reported in the IFU
Contra-indications
Indicate the information as reported in the IFU
Target populations
Indicate the information as reported in the IFU
Grouping justification
Using the principles of MDCG 2022-21 coupled with the sampling methods of notified body described in MDCG 2019-13, [manufacturer name] reached the conclusion that grouping of devices described in Appendix I – Devices in scope of PMS plan, is appropriate for the following reasons:
Select relevant and applicable reasons in the non-comprehensive list below.
- The PSUR contains class III devices under the same Basic UDI-DI,
- The PSUR contains class IIb devices under the same 4th level of EMDN code,
- The PSUR contains class IIa devices under the same MDN/MDA code,
- The PSUR contains several Basic UDI-DI for class III devices, several 4th level of EMDN code for class IIb devices several MDN/MDA codes for class IIa devices and/or several class I devices but they are all used together/in combination during the same procedure to achieve the intended performance and safety for the treatment/diagnosis of the patient.
- The PSUR contains devices of several classes but they are all accessories intended to be coupled with [Device short name],
- The PSUR contains class III devices with different Basic UDI-DIs but they are considered equivalent according to the MDCG 2020-5 as justified in the clinical evaluation report [DoC+Rev] / if the equivalence has not been claimed in the CER, include the equivalence table in appendix of this PMS plan.
- The PMS report only contains class I devices that share the same intended use/indications for use and are based on a similar technology.
- The PSUR contains devices for which the grouping has been approved by NB (See [Doc number]
XXX Further justify the elements retained above with factual evidence and justify the benefits to report multiple devices in one PSUR or alternatively the disadvantages to report each device in separate PSURs.
Considering the characteristics of devices presented in Appendix I – Devices in scope of PMS plan, the leading device has been selected with the highest classification and highest expected lifetime and is XXX. The leading device will drive the schedule of the PSUR such as data collection period covered, PSUR frequency, issuance timeline, PSUR reporting through EUDAMED, irrespective of the certification dates and classes of other devices.
The principal milestones for the schedule of the PSUR are described in Section 9.
Note: Remove this section when the grouping is not applicable, for instance, when there is only one device in scope.
Risk management, threshold values and trends
Threshold values and indicators
Risk management activities have been established per Article 10(9) of the MDR and EN ISO 14971:2019+A11:2021. Consider the addition of (EU) 2022/2346 for devices without intended medical purposes.
As part of the risk estimation, the likelihood and severity of risks have been determined to establish the benefit-risk profile of device(s) in scope of this PMS plan. As a result, the likelihood and severity of risks will be used as indicators and threshold values of PMS activities to continuously reassess the benefit-risk of [device short name].
The following table references the risk management documents and describes the threshold values of undesirable risks identified.
Table 4: Threshold values from risk management file
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Risk Management and Threshold Values |
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Risk Management Procedure |
Include the document number of risk management procedure |
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Risk Management Documents |
Include the document number of risk management documents with the revision |
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Risk |
Likelihood |
Severity |
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Acceptable Risk |
Likelihood and Severity as reported in the Risk Management Documents |
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Undesirable Risks |
||
All risks identified during the PMS activities will be compared to the threshold values identified in Table 4, to evaluate if the benefit-risk profile may be affected.
Trends
A trend analysis will be performed for each incident / for each non-serious incident (including known undesirable side-effects) via the curve slope of trendline calculated for the incident rates reported year by year. The incident rates will be divided by region (i.e., EEA+TR+XI vs WW) for each specific device (i.e., Basic UDI-DI or device model as necessary) according to the three IMDRF Adverse Event codes assigned:
- Per Annex A for device problem,
- Per Annex C for investigation finding, and
- Per Annex F for health impact.
The next figure represents how the granularity of trends will be calculated.
Figure 1: Table of trend data analysis
As represented in the next figure, any trendline slope with an absolute value greater than or equal to 0.001 shall be considered significant. This corresponds to a change of 0.10 percentage point per collection period. This threshold was defined to identify only materially relevant variations in the trend and to avoid overinterpretation of minor fluctuations inherent to routine data collection. It is considered appropriate for a limited number of data points, where smaller slope values may reflect normal variability rather than a meaningful change in product or process performance.
For the same trending, one statistically significant increase shall be assessed as an anomaly, and two consecutive significant increases (i.e. over two collection periods) shall require corrective and/or preventive actions, unless duly justified
Figure 2: Example of trend analysis
By derogation to the previous paragraph, no trend analysis can be performed for the first data collection period. Similarly, no reliable trendline can be established at the second data collection period. Therefore, when only two data points are available, any increase greater than or equal to 0.50 percentage point (or 0.005) as compared to the first data collection period shall be considered significant. This more flexible threshold is considered appropriate at this stage, as the assessment is based solely on two observations and should avoid overinterpretation of minor routine fluctuations. If this significant increase is confirmed during the third data collection period, corrective and/or preventive actions shall be required, unless duly justified.
As a result, the observation period of trends starts after two data collection periods, while corrective and preventive actions may be defined and implemented after three data collection periods and then every year.
In addition, as long as the rates in severity or likelihood (i.e. thresholds) remain within the limits defined in the risk management file (see Section 4.1), the benefit-risk ratio will be considered unaffected. For any significant increase beyond the thresholds defined in the risk management file, the trend shall be justified for its impact on the benefit-risk ratio. Any negative impact on the benefit-risk ratio shall be reported to the competent authorities according to Article 88 of the MDR.
Equivalent / similar devices
The following products are equivalent or similar to [device short name].
Table 5: Equivalent and similar devices
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Device Name |
Manufacturer |
Equivalent or Similar devices |
|---|---|---|
Note: If no equivalent/similar devices are applicable, this section can be removed. However, most of the PSURs should at least have similar devices (except for novel technologies).
PMS activities
PMS activities in scope of this PMS plan are described in the following table. As part of the PMS, a proactive post-market clinical follow-up has been defined under the PMCF plan: [Doc+rev].
Here is a proposal that needs to be customized as needed.
Table 6: PMS activities
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PMS Activity |
Description and methods |
Outputs |
|---|---|---|
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Information concerning serious incidents |
Collection of data: The serious incidents resulting from complaints handling will be collected and analyzed by Basic UDI-DI/device model over several contiguous one-year periods. For every Basic UDI-DI, the incidents will be presented using the IMDRF Adverse Event Terminology by:
Reference procedure (if applicable): XXXX |
Assessment of data: Optional The analyzed data will be trended to detect any statistical increase and need of CAPA. The analyzed data are used to characterize the overall device safety. Any new risks will be identified, and any existing risks will be compared to the threshold values defined during the risk management activities. The analysis and results will be documented in the PMS Report / PSUR. |
|
Information from Trend Reporting |
Collection of data: The non-serious incidents resulting from complaints handling will be collected and analyzed by Basic UDI-DI/device model over several contiguous one-year periods. For every Basic UDI-DI, the incidents will be presented using the IMDRF Adverse Event Terminology by:
Reference procedure (if applicable): XXXX |
Assessment of data: The analyzed data will be trended to detect any statistical increase and need of CAPA. Any new risks will be identified and the analyzed data on existing risks will be compared to the threshold values defined during the risk management activities to verify the continuous suitability of B/R ratio. When a negative impact on B/R ratio is observed, the need of trend reporting per Article 88 of the MDR is evaluated. The analysis and results will be documented in the PMS Report / PSUR. |
|
Information from Field Safety Corrective Actions (FSCA) |
Collection of data: Any FSCA initiated, updated, closed during the PSUR period and in relation to the [device short name] will be documented including: type of actions, issuing date, scope, status, manufacturer reference number as well as brief description of actions, reason(s) for action and impacted regions. Reference procedure (if applicable): XXXX |
Assessment of data: The FSCA data will be compared to the information available in the last PSUR. The analysis and results will be documented in the PMS Report / PSUR. |
|
Preventive and / or Corrective Actions (CAPA) |
Collection of data: Any CAPA initiated, updated, closed during the PSUR period and in relation to the [device short name] will be documented including: type of actions, initiation date, scope, status of actions, root-cause, manufacturer reference number as well as CAPA description, and status of the CAPA (effective or not). Reference procedure (if applicable): XXXX |
Assessment of data: The CAPA data will be compared to the information available in the last PSUR. The analysis and results will be documented in the PMS Report / PSUR. |
|
General post-market clinical follow-up information |
||
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Feedbacks and complaints from users, distributors and importers |
Collection of data: All feedback from users, distributors and importers not reported in the complaint handling system, will be reviewed to determine if they meet the definition of incident under MDR and are related to [device short name]. Feedback that meets both criteria above will be classified by Device Problem according to IMDRF Adverse Event Terminology (Annex A) with the occurrence rate and the justification of data inclusion under this IMDRF code or data exclusion (when applicable). As a result, CAPA initiated following the feedback will be described. Reference procedure (if applicable): XXXX |
Assessment of data: The feedback from users, distributors and importers not reported in the complaints handling system will be assessed to determine if CAPAs are required based on the occurrence rate. The analysis and results will be documented and discussed in the PMS Report / PSUR. Note: though MDCG2020-21 considers this activity under PMCF, [manufacturer short name] will conduct this review during PMS activities. |
|
Scientific Literature Review of relevant specialist or technical literature |
Collection of data: A literature search will be implemented as part of PMCF activities to detect the published articles related to the [device short name] and bring clinical evidence to confirm safety and performance of the device. The detailed information is described in PMCF plan. Results of literature search implemented will be summarized to identify the key and other safety and performance parameters with the associated specifications. The data will be classified under articles on on-label or off-label /mis-use. Reference procedure (if applicable): XXXX |
Assessment of data: Any new risks will be identified and the analyzed data on existing risks will be compared to the threshold values defined during the risk management activities to verify the continuous suitability of B/R ratio. Data on safety and performance outcome parameters will be reviewed to confirm the alignment with acceptance criteria defined based on the state of the art (as discussed in the last clinical evaluation report). Off-label uses will be analyzed to determine the presence of systematic off-label / mis-uses. The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. |
|
Public Database |
Collection of data: A vigilance / recall search will be implemented as part of PMCF activities to detect any safety events reported for [device short name] and bring additional clinical evidence for the demonstration of safety and performance of the device. The detailed information is described in PMCF plan. Results of vigilance and recall search implemented will be summarized to identify the device-related and patient-related risks. Reference procedure (if applicable): XXXX |
Assessment of data: Any new risks will be identified and the analyzed data on existing risks will be compared to the threshold values defined during the risk management activities to verify the continuous suitability of B/R ratio. The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. |
|
Public Registry Data |
Collection of data: A clinical trial search will be implemented as part of PMCF activities to detect the unpublished articles related to the [device short name] and bring clinical evidence to confirm safety and performance of the device. The detailed information is described in PMCF plan. Results of clinical trial search implemented will be summarized to identify the key and other safety and performance parameters with the associated specifications. The data will be classified under articles on on-label or off-label /mis-use. Reference procedure (if applicable): XXXX |
Assessment of data: Any new risks will be identified and the analyzed data on existing risks will be compared to the threshold values defined during the risk management activities to verify the continuous suitability of B/R ratio. Data on safety and performance outcome parameters will be reviewed to confirm the alignment with acceptance criteria defined based on the state of the art (as discussed in the last clinical evaluation report). Off-label uses will be analyzed to determine the presence of systematic off-label / mis-uses. The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. |
|
Post-market clinical follow-up information on equivalent or similar devices |
||
|
Scientific Literature Review of relevant specialist or technical literature |
Collection of data: A literature search will be implemented as part of PMCF activities to detect the published articles related to similar/equivalent devices and bring clinical evidence to confirm safety and performance acceptance criteria to evaluate the safety and performance of [device short name]. The detailed information is described in PMCF plan. Reference procedure (if applicable): XXXX |
Assessment of data: Safety and performance data on similar/equivalent devices obtained for the data collection period will be reviewed in comparison to the safety and performance data obtained with [device short name] for the same period. The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. |
|
Public Database |
Collection of data: A vigilance / recall search will be implemented as part of PMCF activities to detect any safety events reported for similar/equivalent devices. The search will bring additional clinical evidence to confirm safety and performance acceptance criteria to evaluate the safety and performance of [device short name]. The detailed information is described in PMCF plan. Reference procedure (if applicable): XXXX |
Assessment of data: Safety events reported for similar/equivalent devices for the data collection period, will be reviewed in comparison to the safety event reported for [device short name] for the same period. The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. |
|
Public summary of safety and clinical performance Only applicable to class III and implantable devices |
Collection of data: A review of safety and performance data published in the PSUR(s) of similar/equivalent devices will be reviewed to confirm the acceptance criteria for the evaluation of safety and performance of [device short name]. The detailed information is described in PMCF plan. Reference procedure (if applicable): XXXX |
Assessment of data: For the data collection period, new or revised safety and performance data obtained from the SSCP(s) of similar/equivalent devices will be reviewed in comparison to the safety and performance data obtained with [device short name] for the same period. The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. |
|
Specific post-market clinical follow-up information |
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If no specific PMCF procedure is required, include a justification. Otherwise, remove the raw. XXXX |
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Patient survey |
Collection of data: Results of patient survey for the data collection period will be documented to demonstrate how the objectives of the specific PMCF procedure are achieved and any findings resulting from the PMCF activity. This includes:
Reference procedure (if applicable): XXXX |
Assessment of data: The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. Conclusions of PMCF evaluation report for the PMCF activities will be documented to ensure a comprehensive assessment of the specific procedure implemented. Especially, the conclusion will confirm and justify:
|
|
User survey |
Collection of data: Results of user survey for the data collection period will be documented to demonstrate how the objectives of the specific PMCF procedure, are achieved and any findings resulting from the PMCF activity. This includes:
Reference procedure (if applicable): XXXX |
Assessment of data: The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. Conclusions of PMCF evaluation report for the PMCF activities will be documented to ensure a comprehensive assessment of the specific procedure implemented. Especially, the conclusion will confirm and justify:
|
|
Device registry |
Collection of data: Results of device registry consultation for the data collection period will be documented to demonstrate how the objectives of the specific PMCF procedure, are achieved and any findings resulting from the PMCF activity. This includes:
Reference procedure (if applicable): XXXX |
Assessment of data: The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. Conclusions of PMCF evaluation report for the PMCF activities will be documented to ensure a comprehensive assessment of the specific procedure implemented. Especially, the conclusion will confirm and justify:
|
|
PMCF investigation |
Collection of data: Results of PMCF investigation for the data collection period will be documented to demonstrate how the objectives of the specific PMCF procedure, are achieved and any findings resulting from the PMCF activity. This includes:
Reference procedure (if applicable): XXXX |
Assessment of data: The analysis and results will be documented in the PMCF evaluation report and the findings will be discussed in the PMS Report / PSUR. Conclusions of PMCF evaluation report for the PMCF activities will be documented to ensure a comprehensive assessment of the specific procedure implemented. specially, the conclusion will confirm and justify:
|
Remove the non-applicable specific procedures and methods of PMCF.
PMS activities as planned in Section 6, will be presented organized by Basic UDI-DI or device model.
PMS methods
The following table describes the PMS methods and procedures used for the PMS plan of [device short name].
Table 7: PMS methods and procedures
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Methods |
Description / related Procedure |
|---|---|
|
PMS system |
[Doc+rev.] indicate the QMS procedure |
|
Collection and Assessment of available information |
See Table above |
|
Indicators and Threshold for continuous reassessment of B/R ratio |
See Table above |
|
Investigation of complaints |
[Doc+rev.] indicate the QMS procedure |
|
Incidents subject to the trend report |
[Doc+rev.] indicate the QMS procedure |
|
Evaluation of statistically significant increase in the frequency or severity of incidents and observation period |
[Doc+rev.] indicate the QMS procedure |
|
Communication with NB |
[Doc+rev.] indicate the QMS procedure |
|
Communication with CA |
[Doc+rev.] indicate the QMS procedure |
|
Communication with EO |
[Doc+rev.] indicate the QMS procedure |
|
CAPA process |
[Doc+rev.] indicate the QMS procedure |
|
Change control process |
[Doc+rev.] indicate the QMS procedure |
|
Traceability during field corrective actions |
[Doc+rev.] indicate the QMS procedure |
PMS report / PSUR
The results of the implementation of PMS plan will be documented in a PMS Report for class I devices/ PSUR for class IIa, IIb and III devices. Data will be collected, trended, analyzed to determine the need of product improvement, update of risk management activities and/or CAPAs as well as communication with the regulatory authorities (e.g., competent authorities) or notified body.
The PMS information will also be reviewed and incorporated into the following documentation:
- Risk Management File as part of the production and post-production information, refer to [Doc+rev.]
- Clinical Evaluation Report (CER), as the PMCF and PSUR results will feed the CER, refer to [Doc+rev.]
- Technical Documentation for compliance to Annex III of the MDR, refer to [Doc+rev.]
- Design history file for any change implemented, refer to [Doc+rev.]
Other documents can also be considered such as biological evaluation report and usability engineering file.
A Periodic Safety Update Report (PSUR) / PMS report will be issued every year as the device is class III/IIb / or every two years as the device is class IIa device / or every three/four years as the device is class I and XXX include a justification for the frequency of class I
PMS schedule
The complete life-cycle of clinical/PMS activities is represented with the following pictures.
Note: SSCP is only applicable for class III and implantable devices.
Figure 3: Clinical/PMS life-cycle
The following schedule has been defined for the PMS activities of [device short name]:
- PMCF Evaluation Report: DD-Mon-YYYY The schedule of PMCF activities can be more detailed if necessary
- PSUR/PMS report:
- Collection period: from DD-Mon-YYYY to DD-Mon-YYYY
- Analysis: from DD-Mon-YYYY to DD-Mon-YYYY
- Submission to NB/in EUDAMED: DD-Mon-YYYY
Appendix I – Devices in scope of PMS plan
|
Basic UDI-DI / EUDAMED-DI |
Device trade name |
Device description |
UDI-DI |
EMDN code |
MDN / MDA code |
Class |
Lifetime |
Certificate number |
NB number |
|---|---|---|---|---|---|---|---|---|---|
|
Leading device |
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|
Other devices |
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