As a medical device manufacturer, you are required to actively monitor the market and develop defined Post-Market Surveillance (PMS) strategies for each product or product family. This enables you to identify and address underestimated complications and issues that were not apparent prior to launch, as well as unforeseen uses of your product throughout the product lifecycle.Post-market surveillance activities can include: handling complaints; vigilance; interviewing patients, users, distributors and transporters; evaluating feedback from the hotline, social media forums to app store reviews; researching surveillance agency databases on incidents and recalls on similar products in the market; and product-specific Post-Market Clinical Follow-up (PMCF) activities. In this context, any activity that is not incident-related counts as active.Through a jointly developed strategy, you can efficiently incorporate this data into your clinical evaluation and save a lot of time and high personnel costs during the (annual) update.Work with us to develop a PMS strategy that is practical, efficient, and MDR-compliant – for greater safety and less effort.
Definition of post-market surveillance (PMS)
Post-Market Surveillance (PMS) refers to a systematic process by the manufacturer for post-market surveillance. How and why PMS is needed is explained in Chapter 7 "Post-market surveillance, vigilance and market surveillance" of the MDR (EU Regulation 2017/745). ISO 13485:2016 and ISO 14971:2022 also require post-market surveillance.Our services in detail
Protecting performance and minimizing risk with smart PMS strategiesUnder the MDR, post-market surveillance (PMS) is mandatory for medical devices and plays a key role in evaluating safety, performance, and clinical benefit throughout the entire product lifecycle. We support you with tailored PMS strategies that go beyond compliance and help you uncover valuable efficiency potential.Always up to date without the extra workload:
Our Live PMS Ticker keeps you informed of national and global regulatory updates in real time. You stay compliant and can respond proactively to any change that affects your PMS system.Digital solutions for intelligent PMS workflows:
We help you select and implement digital tools that streamline and automate your PMS processes - saving time and resources long term.Empowering your team with hands-on knowledge:
We train your staff on PMS requirements under the MDR and show how to manage feedback, complaints, and literature searches efficiently and systematically.Expand internationally without starting from scratch:
We adapt your existing PMS setup for international markets, ensuring consistency and reducing duplication of effort.Custom PMS strategies for your specific portfolio:
We design PMS approaches that fit your product structure and internal processes. The result: meaningful data with manageable effort.Detect trends before they escalate:
We analyze your PMS data systematically to identify patterns early and derive targeted actions – keeping you ahead of the curve.Documents that support both compliance and decision-making:
We develop PMS plans, reports, and PMPF documentation that meet all IVDR requirements while supporting your internal quality and business decisions.Confident communication with authorities and notified bodies:
We assist you during audits and regulatory interactions with clear, compliant documentation and expert guidance throughout the process.
Get in touch with us – together, we’ll determine how we can support you reliably and thoroughly.
Our Live PMS Ticker keeps you informed of national and global regulatory updates in real time. You stay compliant and can respond proactively to any change that affects your PMS system.Digital solutions for intelligent PMS workflows:
We help you select and implement digital tools that streamline and automate your PMS processes - saving time and resources long term.Empowering your team with hands-on knowledge:
We train your staff on PMS requirements under the MDR and show how to manage feedback, complaints, and literature searches efficiently and systematically.Expand internationally without starting from scratch:
We adapt your existing PMS setup for international markets, ensuring consistency and reducing duplication of effort.Custom PMS strategies for your specific portfolio:
We design PMS approaches that fit your product structure and internal processes. The result: meaningful data with manageable effort.Detect trends before they escalate:
We analyze your PMS data systematically to identify patterns early and derive targeted actions – keeping you ahead of the curve.Documents that support both compliance and decision-making:
We develop PMS plans, reports, and PMPF documentation that meet all IVDR requirements while supporting your internal quality and business decisions.Confident communication with authorities and notified bodies:
We assist you during audits and regulatory interactions with clear, compliant documentation and expert guidance throughout the process.
Get in touch with us – together, we’ll determine how we can support you reliably and thoroughly.
Save your time and money with smart updates
Adapting a clinical evaluation from MDD to MDR usually involves lot of efforts. Once a good MDR-compliant foundation has been created and the associated PMCF measures have been optimally defined, the updates can be created much faster and thus more cost-effectively.
Let's find out together and without obligation how we can optimize your clinical evaluation and your post-market surveillance. We are happy to hear from you!
Our Offer:
We take full care of your clinical evaluation. We also remind you when an update is due, collect the relevant information and carry out the update.Your Advantages:
The forthcoming updates run via the PMCF measures that we have previously defined in a smart and efficient manner as part of your clinical evaluation. We keep your effort as low as possible and you always get your clinical evaluation from one source.Let's find out together and without obligation how we can optimize your clinical evaluation and your post-market surveillance. We are happy to hear from you!
PMS and its importance for your medical devices
The importance of PMS for your medical devices can be viewed from different perspectives:- Post-market surveillance is part of the quality management (particularly risk management) of medical devices in Europe.
- It is used to monitor the safety and performance of medical devices after they have been placed on the market.
- Information on the use of medical devices is collected and analyzed in order to identify risks or problems in the market at an early stage and to initiate measures.
- Post-market surveillance helps protect patients and users and helps to ensure that medical devices remain safe and effective.
Your PMS requirements - our solutions
Our team will work with you to develop your PMS strategy that meets your requirements and create all the basic documents such as the PMS process, PMS plans and reporting templates.Use our quick check to find out exactly what you need and how we can support you!Post-market surveillance (PMS) for medical devices under the MDR
Post-market surveillance (PMS) is now required under both MDR and IVDR. You probably already have hands-on experience with the challenges PMS under MDR or IVDR presents. You may already be familiar with one of the scenarios:
- PMS requires more resources than expected.
- Your team is not yet fit enough to deal with the challenges that the two regulations pose to them.
- There were minor or major nonconformities in your last audit.
We want to be part of the solution to your PMS challenges! Check out our following Quick Check to see what options we have for you!
Quick check
How you can profit from our PMS expertise
In our experience, PMS challenges you in six different ways. Assign yourself to a profile below and see what solution we can offer you. Does that sound interesting? Should we have a non-committal discussion about it?We look forward to hearing from you!
1. Kick Start
You need a reliable PMS foundation and a well-thought-out strategy.
Are you aware of PMS requirements and are at the beginning of your PMS implementation? Or do you want to start with basics and need PMS strategies for implementation? No problem, we can help you get started!Our approach:We don't turn your business upside down. Our goal is to develop a regulatory compliant and implementable strategy for your company. In order to be on the same wavelength, we need to get to know you and your product portfolio and record the current situation. In a collaborative workshop, we will create an individual draft strategy for you. Finally, we ( together ) implement your PMS with the developed strategy and measure its effectiveness.We get you safely to the finish line - Learn more now!
2. Fast Lane
You need to accelerate
Help, fast! You have a deviation in your PMS and now need a helping hand to quickly bring you back into compliance. Together, we'll get everything back on track!Our approach:When you need to act fast, experience matters! Our experts know how to resolve a non-conformance in a timely manner. We are aware that you are under pressure and that the clock is ticking. Together, we will quickly find the optimal solution to resolve your non-conformance. With us, you have a reliable partner at your side for difficult times.We are ready for your pit stop!
3. Power, Power, Power!
You are a tuning fan
You have an established PMS system, but you lack the power to complete all tasks properly and on time? Our team is here for you!Our approach:With too few resources, even the best PMS system cannot function properly. We provide you with the capacity you need at such times and help you meet all the requirements. Thanks to our years of practice, we quickly learn the business and reliably complete the tasks at hand.Looking for reinforcement for your race team? We look forward to getting to know you!
4. Saving Energy
You are committed to efficient processes
You need too much internal capacity (personnel, time, financial) with your established PMS system. We help you to make your processes more efficient.Our approach:For us, saving energy is more than just using software. We know that it is challenging to optimize resources while being as energy efficient as possible. We work with you as an objective partners to look at your PMS processes to improve your energy efficiency while complying with MDR regulations. Even small changes lead to big savings over time!Save your engine with our support!
5. Driver´s License
Your team needs a PMS update
You have internal capacities which need to be trained accordingly. No problem, our trainers are happy to share their expertise with you.Our approach:Within the framework of the Metecon Academy, we offer you customized training for the entire team. Together with you, we get an overview of the current know-how. Our trainers are not only experts in their field - we also care about your success! At the end of our workshops, we work together on a trial run on one of your products to ensure the effectiveness of the training content in practice.We will gladly provide you with further information!
Are you looking for a different requirement?
What motivates us
The product is in the market, does the clinical evaluation have already been completed?
No, because as a manufacturer you must be prepared to guarantee the safety and performance of your product over the entire product life cycle. To determine suitable Post Market Clinical Follow-Up (PMCF) activities in the context of Post-Market Surveillance (PMS), there are various ways, such as the evaluation of specific questions with a large number of patients, long-term observations of patients or research on known risks from the literature. Based on this data, you can identify any problems with your product, eliminate them at an early stage, and thus continually adapt your follow-up products to meet the needs of their users.Post-Market Clinical Follow-Up (PMCF)
Possible PMCF measures include research in scientific literature and in encounter databases, as well as surveys of patients and users of the product. Post-Market Clinical Follow-Up (PMCF) studies are so-called market surveillance studies conducted for medical devices with a legal CE mark. The medical device must be used within its intended purpose, and the study design must not include additional procedures that are either invasive or stressful. The purpose of these studies is to generate further clinical data to be included in the clinical evaluation report. Since ISO 14155 makes no distinction between medical devices with and without CE marking, this standard applies equally to all studies/clinical trials.We bring structure to your internal processes of PMS and show you ways to efficiently incorporate this data into the Clinical Evaluation, gladly with our support. If the results show that you need to conduct a PMCF study, we plan this study efficiently and ensure that it runs smoothly. In particular, we are happy to assist you with the preparation of the PSUR or PMS report - we know that these are often challenging for manufacturers. Want to learn more?Our initial consultations are of-course free of charge!MDR: Product Lifecycle Reporting
The MDR defines new responsibilities for you as a medical device manufacturer such as a regular preparation of plans and reports. Some updates follow a fixed schedule, others need to be integrated in this cycle reasonably.The figure shows the plans and reports in a logical sequence. This makes it easier to identify interdependencies. The collection of clinical data must be planned already during product development. After approval you are in a continuous process of preparing plans and reports throughout the entire product lifecycle. To comply with all requirements and be able to provide all documents in a timely manner, the individual stages need to be aligned carefully.
![[CR #494746] @ MDR: Product Life Cycle Reporting[/CR]](/media_lib_files/1941_product_life_cycle_1200x1200_neu_2025-09-17_komp.png)
Explanation of the stages
+CEP - Clinical Evaluation Plan
The CEP defines the scope of the clinical evidence. It defines the aspects of the intended purpose (and thus intended clinical performance and clinical benefit) and residual risks. The parameters required to assess the benefit-risk ratio are identified and all marketing claims must also be substantiated by appropriate data. The strategy (route) of the clinical evaluation is determined taking into account these aspects and parameters, preclinical and clinical data already availabe, the risk class, and possible equivalent products. Finally, the search strategy is defined, including at least a literature search (planning of sources, search terms, selection and appraisal criteria) and, where necessary, a clinical study. The CEP is updated if the necessary scope or route changes.
+CDP - Clinical Development Plan
The CDP defines how you will generate the required clinical data. This may include exploratory studies, first-in-man studies, feasibility studies, and pilot studies up to proof-of-concept studies. An outlook on possible PMCF activities is also possible at this point. The CDP is updated when study objectives are changed or additional studies are added.
+CER - Clinical Evaluation Report
The CER presents the results of the evaluation of all clinical data. Data from the product or from proven equivalent products are collected, selected, evaluated, and analyzed. It is examined if and to what extent the requirements for performance/benefit and safety (risks and undesirable side effects) are met and the acceptability of the resulting benefit-risk ratio is assessed. The CER also identifies the need for the collection of futher clinical data as part of PMCF. It is continuously updated with PMCF data to asses continued conformity with the GSPRs.
+PMCF Plan - Post-market clinical follow-up Plan
PMCF is formally part of PMS and is intended to extend the clinical evidence on the product over its entire life cycle. PMCF also answers open questions that could previously only be estimated as part of the clinical evaluation (e.g. long-term behavior, monitoring of side effects and contraindications). The PMCF plan describes the methods and procedures for the proactive collection or generation of clinical data. The scope may vary depending on the PMCF activities required and a PMCF master plan may be created which refers to various other plans defining the individual activities. The PMCF plan is updated when necessary, such as when the need for a change is identified in the PMCF report or when the CER has identified changed or additional PMCF requirements.
+PMS Plan
In the PMS Plan, the manufacturer defines how the device is to be monitored after it has been placed on the market, including the data to be collected. In the device-specific planning of these activities, the characteristics and associated risks of the device and the findings from the CER must be taken into account. Furthermore, the methods used to evaluate the data and the evaluation criteria are defined. Data collection on the market must be carried out proactively. The PMS plan must be updated if there are new aspects to be considered (e.g. a new clinical benefit), if opportunities for improvement are identified, or if there is a change in the devices. It must also be updated when new data sets become available that should be included in PMS.
+PMS (including Vigilance) and PMCF Activities
When planning proactive PMS activities, it is important to consider which activities are to be carried out as PMCF activities, as not every proactive activity conducted as part of the PMS will meet the criteria for PMCF. Typical proactive PMS or PMCF datasets are searches of the scientific literature and published reports on the clinical experience of either your own device or equivalent devices. Information regarding similar devices is also collected as part of an adverse evet or FSCA database search. User surveys can be conducted as either a proactive PMS or a PMCF activity, depending on the survey objective.Reactive datasets (part of PMS) may include, for example, serious incidents, FSCAs, and trend reports. Information and events are evaluated as soon as they are received, and the corresponding follow-up measures are initiated immediately. In this context, vigilance describes the reporting of serious incidents and FSCAs to the authority. For this purpose, every manufacturer needs an appropriate system in which the evaluation and analysis of such events as well as their timely reporting is ensured. Reporting is carried out via EUDAMED.
+PMCF Report
The clinical data and, if applicable, interim results from PMCF activities are summarized and presented in the PMCF report. Data are checked for confirmation of clinical evaluation and the activities for their effectiveness. The PMCF report can also decide on follow-up actions. It is updated regularly, following the data collection periods as set in PMS.
+PMS Report and Periodic Safety Update Report (PSUR)
A PMS Report is created for Class I devices and includes a summary of the results from PMS data (including PMCF data) obtained during the data collection period. Based on these results, a conclusion is drawn, which is then input, for example, to the clinical evaluation. Additionally, CAPAs are outlined and justified. A PSUR is prepared for Class IIa, IIb, and III products and, like the PMS report, contains a summary of the results from market data obtained during the most recent data collection period. Based on these results, a conclusion is drawn which is input for the clinical evaluation, and CAPAs are presented and justified. In addition to the topics included in the PMS report, the PSUR also contains the conclusions from the benefit-risk assessment, the main findings from PMCF, and the volume of sales of the device, as well as further information, e.g. on the frequency of use.The purpose of both the PMS report and the PSUR is to gain insights into the safety and performance of the device on the market over its entire life cycle, which can be used for further product development and to ensure product safety at all times. The PMS report is prepared as required and should be updated shortly before each update to the clinical evaluation. The PSUR is updated regularly (also for legacy devices) as defined by the device’s risk class.
+SSCP - Summary of Safety and Clinical Performance
The SSCP report must be prepared for Class III and implantable devices. The purpose of the short report is to present the device in the context of its use, to explain residual risks and any undesirable effects, warnings, and precautions, and to present alternative options with regard to therapy and diagnosis. The SSCP will be referenced in the instructions for use or labeling and will be made available to the public via EUDAMED. It must be written in such a way that it can also be understood by laypersons, if they are the intended users. The SSCP is updated annually.
Successful adaptation to the MDR: Our whitepaper series for your medical devices
Have you already adjusted your technical documentation to comply with (EU) 2017/745 (MDR)? If not, it's time to take action and ensure that the technical documentation of your medical devices meets the requirements of the MDR. Only by doing so can you guarantee the safety, quality, and effectiveness. In our whitepaper series, you will find valuable best practices for adapting your existing products to the MDR. Start directly with Part 1: "Conversion of Your Existing Products" to secure market access for your products in the EU!
(Available only in German Language)Download our whitepaper for free now.
(Available only in German Language)Download our whitepaper for free now.
