Post Market Surveillance
Post Market Surveillance for medical devices is a collection of processes and activities EU MDR & US FDA uses to monitor the safety and effectiveness once they are on the market. Post market surveillance system helps in actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime. Results of PMS helps continuously update the risk file and takes necessary CAPA controls on time.
To comply with the European Union new Medical Device Regulation manufacturers must conduct PMS as outlined in NEW MDR Article 83. The above regulators insist on Post Market Surveillance to makes every effort to assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once medical devices are widely used by health care providers and patients, new issues occasionally arise. These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance. Clinical outcome facilitates the development of new devices or new uses for existing devices.
Post Market Surveillance Report (PMCR)
All class 1 medical device manufacturers including class Is, Im & Ir are required to summarize the results and conclusions of the data gathered during the conduct of surveillance as per PMS plan. The summery of conclusion of data with description of corrective and preventive action if necessary taken collectively called Post Market Surveillance Report (PMSR).
Post Market Surveillance Plan (PMS)
The manufactures should NOT consider post market surveillance plan for product family, it should consider to have a PMS plan that is specific to Intended use, construction, risk class and site of action and also the possible outcome.
Continuous evaluation and improvement of the process is at the very heart of this change, the MDR introduces more clear and prescriptive measures based on device risk level.
PMS requirements are very similar for both MDR and IVDR and are mentioned in 7th chapter. Chapter 7 points out to specific Annexes describing more in detail the provisions relating to this topic.
Contents of Post Market Surveillance Plan (PMS)
Annex III, describes what information shall be included and specifies that this post market surveillance Plan shall be part of the device Technical Documentation. The important pointers are the following..
- Information concerning serious incidents, including information from Periodic Safety Update Reports (PSUR), and Field Safety Corrective Actions (FSCAs)
- All records related to non-serious incidents and undesirable side-effects if any
- Important technical literature and or databases
- Feedbacks and complaints provided by users and those from supply chain
- Similar Medical Devices information
- Proactive and systematic process to collect information concerning to device in question.
- Appropriate methods to assess the collected data
- Procedure for continuous reassessment of the benefit-risk analysis and of the Risk Management
- Appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field
- Procedure to communicate with Competent Authorities, Notified Bodies or any other regulatory bodies
- Procedure to identify and initiate Corrective Actions
As for the Post-market Surveillance Report, the Periodic Safety Update Report shall present Results and conclusion of data gathered from the Post-market Surveillance Plan, includes rationale and description of CAPA taken.
Post Market Clinical Follow Up
When conducting Post Market Clinical Follow Up, the manufacturer shall proactively collect and evaluate clinical data obtained with the aim of confirming the safety and performance throughout the expected lifetime of the device for ensuring the continued acceptability /suitability of identified risks (residual risk) and of detecting any emerging new risks on the basis of factual evidence collected.
If a Medical Device has gained CE Marking based on clinical evidence from a substantially equivalent and similar device, it is a must to conduct PMCF Plan.
If the manufacturer has provided long-term clinical data on the actual device to demonstrate safety, performance, intended use, and stability, a post-market clinical follow-up study may not be necessary.
This page provides important information to be followed by the Organization for conducting Post-market clinical follow-up studies as per MEDDEV 2.12/2 rev 4 as part of maintaining Notified Body CE Certificate.
A Clinical follow-up study is carried out in cases any residual risks are identified or not clear on long term clinical performance that may impact the benefit/risk ratio.
In order to provide evidence of the long term safety and performance of the device, data received via PMS and PMCF are considered most useful for updating the CER throughout the life cycle.
PMCF is a must where there is very limited clinical data for a legacy device and becomes vital where long term data gaps or unanswered questions related to the usage of the device and certain indications, or novel features of a new device exists.
Post Market Clinical Follow Up Plan (PMCF Plan)
As per the new Medical Device Regulation (EU MDR), the Plan shall be a continuous process that updates the Clinical Evaluation Summary Reports and shall be addressed in the manufacturer’s PMS Plan. A PMCF study plan is executed considering the following points
- PMCF study plan must be designed with the aim to confirm the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks based on factual evidence.
- PMCF plan must contain the period of study, plan number, PMCF procedure, date of planning, device information, and also confirm or disprove the acceptability of the previously identified risks, discover new risk and evaluate clinical safety and performance.
- The PMCF plan should describe the appropriate methodology selected for the study
- PMCF plan should contain inclusion and exclusion criteria
- PMCF plan should describe the process of clinical data analysis and interpretation of the results.
- Special control measures needed to be considered and adopted during the study must be identified in the plan
- PMCF plan should be filled with the respective details with authorization of the personnel prepared by, reviewed by and approved
A PMCF study Plan will help manufacturers and Notified Bodies in the following manner:
- Demonstrate, for its intended use, clinical safety and performance of a device through its lifetime and
- Device’s performance to a broad spectrum of physicians and patients.
- The Plan should have adequate interim follow-up periods for early detection of problems as well as long-term follow-up.
- The procedure, plans, and relevant records should be controlled and submitted to NB.
Circumstances under which PMCF study to be initiated
- High product-related risk
- High-risk implant/drug-device combination
- Pediatric use high-risk devices
- The worst case use scenario [ Severity/Treatment / hard to reach areas]
- Unanswered questions of long-term safety and performance
Post Market Clinical Follow up Methodology
The most common methodologies adopted for PMCF studies are the following
- Extended follow up of patients enrolled in premarket investigations
- A new clinical investigation
- A review data derived from the device registry.
- Review of relevant retrospective data from patients previously exposed to the device
Periodic Safety Update Report
The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. PSUR is for devices that are low to high-risk, such as Class IIa, IIb, and III. Post-Market Surveillance provides input to Periodic Safety Reports (Results and conclusions of PMS data, vigilance reporting and current status of these devices on the European Market).
The new Medical Device Regulation (MDR) has greatly expanded the standards for tracking medical devices after they have been released to the market and are being used by consumers or patients. The manufacturer must incorporate and track a surveillance device as part of Harmonized Standard EN ISO 13485:2016, according to MDR/IVDR Chapter VII.
- Post market data collected.
- Methods for analyzing the collected data
- Actions taken to counter the data
- Actions taken such as CAPA, Vigilance, Recall etc.;
- Analysis and Conclusion of Data
The above are collected and documented as per PMS Plan mentioned in article 84 and article 79 in MDR & IVDR respectively. MDR / IVDR class 1 device permitted to keep Post Market Surveillance Report (PMSR) and Class 11a, Class 11b & Class 111 products Periodic Safety Update Report (PSUR)
Content of Periodic Safety Update Report (PSUR)
The contents of this report are outlined in Article 86 of the MDR listed below.
- Summary of the PMS and covering findings of Post Market Clinical Follow Up (PMCF)
- Data analysis and Conclusions / Result
- CAPAs taken against actions.
- Result of Risk Analysis / Residual Risks
- Sales volume, Geographical Location, User group
Periodic Safety Update Report (PSUR) Timeline
||NB Conformity Assessment Review
||Every 24 months
|Class 11b (Non Implant)
||NB Conformity Assessment Review
|Class 11b (Implant)
||EUDAMAD / NB Conformity Assessment Review
||EUDAMAD / NB Conformity Assessment Review
|IVD Class A,B
|IVD Class C
||NB Conformity Assessment Review
|IVD Class D
||EUDAMAD / NB Conformity Assessment Review
Role of I3CGlobal in writing and documenting PSUR
- Development of Procedures and necessary templates.
- Review of PMS data and conclusion derived by the manufacturer as per PMS plan. Unsatisfied reports; we will provide expert help to solve the issue.
- Review of PMCF conclusion by the manufacturer. Incase of deficiency we provide expert help to solve the issue.
- We also help in rewriting PMS and PMCF if required.
- Review of risk-benefit ratio, residual risk, correlate with PMS and CAPA and design changes.
- Special emphasis on review of custom made devices.
- Check details in PSUR against estimate evaluation of the size and other characteristics of the population using the device.
- Modification in PSUR based on rationale and description of any preventive and corrective actions taken against each risk and CAPA.
PSUR Case Study Presentation
Need help with Periodic Safety Update Report documentation including Data Analysis & Writing. Contact via below email.
(Clinical Evaluation Report Writer, Consulting, Document & CER Writing Services with PMS, PMCF, PSUR)
Worried or confused about MDR Article 61 or MEDDEV 2.7/1 Revision 4 Clinical Evaluation Report?
No worries. We review your current clinical evaluation report, CER writing process from top to bottom by our expert writers.
If so, is it really necessary for the makeover to Article 61 we send you a formal offer for your approval.
Before we send the offer we take you to the cockpit and explain what we do and what you must do in due course.
Important things about CER Writing:
- Avaliablity of equivalent device 25% fees discount
- Drug Device combination products 40% additional fees
- Active Implantable Device 40% additional fees
- Additional Fess for paid scientific Literatures. The fees may vary between 150-350 USD
- Complete activities done in cloud. Consultants/Clinical writers travel to client located limited to emergency only.
- The above fees is for each clinical significance (Clinical Indication) of the medical device.
- We practice to complete a Class IIb CER writing for a single clinical indication in less than 120 days.
How many scientific Literatures must be added to the CER documenatation?
Depends on the device; 10 - 15 numbers of articles discussing Intended use, patient population, user environment, Contraindication, Warning, Material suitability, Device Safety & Residual Risks.
Is it necessary to attach the full text of the selected article? Does this violate copyright laws?
Yes, the full text of the selected articles must be attached in the CER documentation. Since, we are not modifying the content of the article, it does not violate copyright law.
Do we need to have an information scientist / Doctor assist in developing the search strategy?
Yes, expert in the field can do indepth literature search using relevant key words and analysis the data. Consultants and medical writers with previous experience also suggested.
What are keywords / Key phrases/ Key Sentences? How should I derive that?
Keywords are defined as words which searchers enter the search engine. Key words are selected form various factors mainly from indication of use, device material characteristics, safety aspects, usage significance, State of art Technology used and residual risks etc.
Why can't I simply search on a keyword in google string and see if I like and attach what I get?
Yes, it can be done, if it is relevant to the medical device under the scope.
What is the average length, in number of pages for CER, or what is the range in pages?
Generally, a good CER with all consolidated supporting documents will be around 300-600 pages, CER alone will be around 15 to 20 pages.
How CER is related to PMS & PMCF? How important is this in Report?
Post Market Surveillance provides the data post sales through various sources on the similar type of device and the device under the scope.
PMCF provide the data only on the device under scope.
Clinical evaluation is continuing process which requires updation depend on the risk classification of the device. While updating PMS and PMCF is one of the bases, if during process any incident observe with subjected device or any similar device related risk and literature steps taken to avoid such incident needs to be analyze and appraise using evaluation..
How Clinical Evaluation Report is related to Equivalent Device? How important is this in CER?
It is practically not possible to conduct investigation considering cost and legal requirements, but at the same time it is important that device should be clinically proven for safe and effective. If an equivalent US FDA or EU approved device in the market helps to proves device safety and effectiveness with respect to technical, clinical and biological parameters.
Equivalent device data are also appraised and analyzed and recorded give more value edition to CERs.
How can I get equivalent Device data? If so not avliable in public domain. What is the solution?
Published data such as IFU, Product Brochures and Specifications, CE Certificate, 510(k) details are easily available on public domains or manufacturer website. If the device has undergone any trial that can be found on https://clinicaltrials.gov/ website.
If no data of equivalent device, appropriate justification with the PMS covering PMCF obtained for the device under scope.
What are the most common deficiencies in reports that a Notified Body can found out in CER?
- Medical Device variants and construction features not covered in the Evaluation.
- Equivalent device data not sufficient or no justification provided
- No data covering state of art and current knowledge and technology
- No enough and robust justification for any deviation from Meddev 2.7.1/ Rev.4 concepts
How good the search obtained from EMBASE? Is MEDLINE, PUBMED or NCBI data is enough?
All sources of appropriate data are ok. Among these PUBMED provides the maximum literature search relevant to the medical device under the question.
Is it necessery to have a statistician appraise each article for statistical validity, or can I do this myself?
It can be done by the individual who is doing CER.
My device is already FDA 510k, can I send 510k letter instead of writing a new CER?
CER is a part of EU Medical Device Regulation(MDD) whereas 510k is that of the US FDA. Ideally, that is not acceptable, however data from 510(k) can be added in the CER.
Can I use videos to demonstrate and argue that device is safe and effective for the intended use?
No. They will not assure the safety and efficacy of the device for a large population. Only the data obtained from PMS and PMCF can assure that the device is safe for use, as per MEDDEV 2.7/1 guideline, literature evaluation is accepted by the notified body.
How Clinical Evaluation is related to Risk analysis as per EN ISO 14971?
The residual risk of the medical device is considered while conducting PMS and PMCF studies. In other way, it is directly related to risk analysis as with the help of clinical evaluation manufacturer should prove device safety and effectiveness which should develop literature to be analyze and appraised for residual risk identified after risk analysis. Warnings, indications, side effects, biocompatibility issues- the overall safety of the devices are assessed from the Risk analysis.
How Clinical Evaluation related with IFU / User Manual?
Contraindication and warning of the medical device mentioned in IFU or User Manual must be considered while performing data research. In other way around IFU or user manual must be modified based on the outcome of Evaluation.
Will a Notified Body would ever inform a company that CER is not adequate, and need data from clinical trial?
Yes. The Notified Body will inform if they require a clinical trial in the below situations. data are insufficient to prove the medical device safety and performance
- where the clinical evidences and clinical data not relevant and accurate to the device in question.
- If the device is new with respect to technology,
- If the device is new with respect to use, material of Construction and application
- No similar device is available in the market
- Multiple recalls on similar device is reported.
What will happen if a company does not update an existing CER during Surveillance audit?
The Notified Body may suspend the CE Certificate Valid if they failed to submit the Clinical Evaluation Report (CER) within the timeline allocated.
Reports to be submitted to the Notified Body? or only for class III devices?
All classes of Medical devices should submit Clinical Evaluation Report (CER) to Notified Body.
How long does a Notified Body takes generally to review the Clinical Evaluation Report CER?
Clinical Evaluation Report (CER) review is a part of Technical Documentation ( Technical File / Design Dossier).
The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated. Why
Clinical risks and residual risk from risk management should be considered for clinical evaluation to prove the safety and similarly any new risk or adverse effect is obtained in clinical evaluation it should be reflected in risk management considering the design or material change if required. They are updated regularly to prove the continuing clinical safety and performance of the device or for the need of modification /rejection of device from the market based on the adverse event or new risk observed.
External clinical experts - Who are they? What is there role?
External Clinical Experts are clinical professionals' expertise in the subject device, choose and trained by Notified body (NB) for the assessment of Clinical Evaluation and provide advices to NB with respect to the regulations, guidance, common specifications and harmonized standards.