How do I become a manufacturer of a medical device under the MDR?

To become a manufacturer of a medical device under the MDR (EU 2017/745), companies must complete a series of regulatory steps. The first step is to classify the product in accordance with Annex VIII of the MDR into one of the risk classes I, IIa, IIb, or III. This classification determines the scope of the regulatory requirements and whether a Notified Body must be involved in the conformity assessment procedure.The manufacturer must then demonstrate a quality management system (QMS), usually in accordance with ISO 13485, which covers all relevant processes such as development, manufacturing, market surveillance, and documentation requirements. At the same time, technical documentation is prepared, containing all evidence of the safety, performance, and clinical benefits of the product. This includes risk analyses, clinical evaluations (CER), instructions for use, and labeling.After successful completion of the conformity assessment procedure, the manufacturer issues an EU declaration of conformity and affixes the CE marking to the product. This marking confirms compliance with all legal requirements and is a prerequisite for placing the product on the market in the European Economic Area.In addition, manufacturers and products must be registered in the EUDAMED system. A responsible person in accordance with Article 15 MDR monitors compliance with all regulatory obligations. Even after market launch, the manufacturer remains obliged to operate an effective post-market surveillance system (PMS) and, if necessary, a post-market clinical follow-up (PMCF), and to regularly update the clinical evaluation in order to ensure safety on an ongoing basis.If you would like more information on the conformity assessment procedure, please download our free white paper “Overview of the requirements of the Medical Device Regulation”. Or book an initial consultation with Ms. Leistner.

How are medical devices approved under the MDR?

The MDR does not provide for a classic “approval procedure”, but rather a conformity assessment through which the manufacturer demonstrates that its products meets the general safety and performance requirements (GSPR) according to Annex I of the MDR.First, the product is classified (MDR, Annex VIII). This determines whether the assessment must be carried out independently (for Class I) or with a Notified Body (from Class Is, Ir, Im, IIa, IIb, or III).The following elements, among others, are examined as part of the assessment:Technical documentation (Annex II & III)Clinical evaluation in accordance with Annex XIVRisk management file in accordance with ISO 14971Quality management system (e.g. according to ISO 13485)The notified body reviews the documentation and conducts audits if necessary. If the assessment is successful, it issues an EU certificate of conformity. The manufacturer then draws up the EU declaration of conformity, affixes the CE marking, and is allowed to officially place the product on the market. From this point on, the manufacturer is obliged to continuously monitor the product (PMS, PMCF) and update the clinical evaluation if necessary.If you would like more information on the conformity assessment procedure, please download our free white paper “Overview of the conformity assessment procedures”. Or book an initial consultation with Ms. Leistner.

What does a complete technical documentation according to MDR look like?

The technical documentation is the central supporting document for a medical device manufacturer to prove that a product meets the general safety and performance requirements of the EU Medical Device Regulation (MDR EU 2017/745). It shows that the product is safe, performs as intended and offer the stated clinical benefits.According to Annex II of the MDR, complete technical documentation must be created for each product or product group, regardless of risk class. This documentation serves as the basis for both the conformity assessment procedure and the CE marking.The technical documentation should be clear, structured, comprehensible and, in accordance with Annex II of the MDR, should include the following content:Product description and specification with references to previous and similar generations of the productInformation to be provided by the manufacturerInformation on design and manufactureGeneral safety and performance requirementsBenefit-risk analysis and risk managementProduct verification and validationIn addition, the post-market surveillance (PMS) plan and the post-market clinical follow-up (PMCF) plan (MDCG 2020-7) must also be included.The technical documentation is a living document: it must be regularly reviewed and updated, especially when new clinical data, regulatory changes or product modifications become available. Complete and up-to-date documentation is therefore not only a prerequisite for CE marking, but also an expression of an effective quality management system and the manufacturer’s regulatory responsibility.If you would like more information on the conformity assessment procedure, please download our free white paper “Overview of the requirements of the Medical Device Regulation.” Or book an initial consultation with Ms. Leistner.

What is a clinical evaluation and why is it so important under the MDR?

The clinical evaluation is a central component of the approval process for medical devices under the EU Medical Device Regulation (MDR EU 2017/745).The MDR defines clinical evaluation as follows:“Clinical evaluation” means a systematic and planned process for the continuous generation, collection, analysis, and assessment of clinical data on a product, which verifies the safety and performance, including the clinical benefits, of the product when used as intended by the manufacturer. (MDR Article 2, sentence 44)The aim is to provide evidence of the safety, performance and clinical benefit of a medical device throughout its entire product life cycle.Every manufacturer, regardless of the risk class, is obliged to carry out a clinical evaluation. This forms the basis for CE marking and is therefore a prerequisite for the lawful marketing of a medical device in the European Union.The clinical evaluation is carried out in several steps: First, relevant clinical data is collected from scientific literature, clinical trials, experience reports or market observations. This data is critically evaluated and summarized in a Clinical Evaluation Report (CER). The aim is to objectively demonstrate that the product performs as intended and that the known and potential risks are acceptable.The clinical evaluation does not end after market launch: Through post-market clinical follow-up (PMCF) activities, manufacturers must collect and evaluate new clinical findings to confirm the ongoing safety and performance of their product.The clinical evaluation is therefore not only a regulatory requirement, but also an essential tool for quality assurance and patient safety – it strengthens confidence in modern, evidence-based medical devices.Would you like to learn more about clinical evaluation? Then feel free to download our free white paper to Creating a Clinical Evaluation in Accordance with the Medical Device Regulation (MDR). Other free offerings from us include the monthly “Clinical Development” consultation hour and the mini-course “Clinical Evaluation”.

How do I prepare a clinical evaluation for my medical device?

Clinical Evaluation is a systematic and traceable process that manufacturers use to demonstrate that their medical device is safe and performs as intended. The evaluation is prepared in accordance with the requirements of the MDR (EU 2017/745) and the MED-DEV 2.7/1 Rev. 4 guidelines, which serve as a practical reference framework for structure and content.The process begins with the preparation of a Clinical Evaluation Plan (CEP). This plan defines the objective, methodology, evaluation criteria, and handling of clinical data. It also specifies which data sources will be considered – for example, clinical trials, scientific literature, market observations or data on equivalent products.The next step is to systematically collect, analyze and evaluate this clinical data. It is important to critically assess the quality, significance and relevance of the data with regard to the product in question. The results are then incorporated into the Clinical Evaluation Report (CER). This report documents the entire evaluation process, summarizes the conclusions, and proves that safety, performance and clinical benefit have been demonstrated.At the same time, the manufacturer must ensure that the evaluation is closely linked to risk management and technical documentation. Changes to the product, new clinical findings or feedback from market surveillance (PMS) may require an update of the clinical evaluation.A carefully prepared clinical evaluation is not only a regulatory requirement, but also a key tool for product safety, transparency and continuous improvement. It builds trust among notified bodies, users and ultimately patients who depend on the safety and effectiveness of the product.Would you like to learn more about clinical evaluation? Then feel free to download our free white paper to Creating a Clinical Evaluation in Accordance with the Medical Device Regulation (MDR). Other free offerings from us include the monthly “Clinical Development” consultation hour and the mini-course “Clinical Evaluation”.

What types of clinical data can be used for the clinical evaluation?

Clinical data forms the basis of every clinical evaluation under the Medical Device Regulation (MDR EU 2017/745). It serves to objectively demonstrate the safety, performance and clinical benefits of a medical device. Different types of clinical data can be used for this purpose, depending on the product, risk class and available evidence.The MDR fundamentally distinguishes between proprietary clinical data and data from external sources. Proprietary clinical data comes from clinical trials conducted by the manufacturer or from market surveillance (e.g., post-market clinical follow-up, PMCF). External data can be obtained from scientific literature, for example.It is important that all relevant data is taken into account. The quality of the data must be critically evaluated with regard to study design, sample size, clinical endpoints, and possible biases. Only high-quality data is suitable for quantitatively assessing safety and performance. However, even data of lower quality can provide information about possible risks and should therefore not be ignored.In addition, manufacturers should always take a risk-based approach: the higher the potential risks of the product, the stronger the clinical evidence must be. Products in higher risk classes therefore often require their own clinical trials, while valid literature and market data may be sufficient for lower classes.Read our blog post “Why indications and target groups determine the requirements for clinical data” to find out what needs to be considered when planning clinical evaluation and testing. Or take a look at the Deficiency-Checklist to see what requirements for clinical data have been set in real conformity assessment procedures.

What is a CEP (Clinical Evaluation Plan)?

The Clinical Evaluation Plan (CEP) is the central planning document for clinical evaluation in accordance with the Medical Device Regulation (MDR EU 2017/745). It defines the strategy, methodology and objectives of the clinical evaluation and forms the basis for the subsequent Clinical Evaluation Report (CER). The CEP ensures that the entire evaluation process is transparent, scientifically sound and compliant with regulations.In the CEP, the manufacturer first defines the intended purpose of the product, its clinical performance and safety objectives and the criteria for evaluating its clinical benefits. It also specifies the data sources to be used for the clinical evaluation, such as clinical studies, scientific literature, market observation data or information on similar products.In addition, the CEP describes the evaluation methodology, including the criteria for the selection, quality, and weighting of clinical data. It specifies how risks, side effects and performance parameters are analyzed and how these results are linked to the requirements of the MDR. The CEP thus serves as a common thread for the clinical evaluation and as a binding basis for subsequent documentation in the CER.A well-structured Clinical Evaluation Plan helps to increase the transparency and traceability of the clinical evaluation and to avoid typical objections by notified bodies. It is also closely linked to risk management, technical documentation and post-market surveillance (PMS).The CEP should be structured and content-wise based on the recommendations of MDCG-2020-13. This guideline from the Medical Device Coordination Group describes in detail how the notified bodies review clinical evaluations and which aspects need to be considered in terms of planning, methodology and documentation.Would you like to learn more about clinical evaluation? Then feel free to download the free white paper Guide to Creating a Clinical Evaluation in Accordance with the Medical Device Regulation (MDR) or take part in our mini-course “Clinical Evaluation”. Or book an initial consultation with Ms. Leistner.

What is a CER (Clinical Evaluation Report)?

The Clinical Evaluation Report (CER) is the central results document of the clinical evaluation according to the Medical Device Regulation (MDR EU 2017/745). It summarizes all findings from the evaluation of clinical data and proves that the medical device meets the essential safety and performance requirements of the MDR. The CER is therefore an essential part of the technical documentation and the basis for CE marking.In terms of content, the CER documents the entire evaluation process. Planning takes place in the Clinical Evaluation Plan (CEP), while the CER maps the collection and selection of clinical data through to its critical analysis and conclusion. All available data from clinical trials, scientific literature, market observations, or equivalent products are evaluated.The aim of the CER is to demonstrate in a comprehensible manner that the product is safe, effective, and clinically efficient when used as intended. Potential risks must also be evaluated in relation to the clinical benefits and proven to be acceptable.When preparing the CER, it is advisable to follow MDCG 2020-13, which specifies a standardized evaluation format and clear test criteria for clinical evaluations. Manufacturers who base their CER structure on these recommendations generally meet the expectations of notified bodies and minimize the risk of complaints.A CER is not a one-time document, but must be continuously updated, for example in the event of product changes, new clinical findings, or relevant results from post-market surveillance (PMS) and post-market clinical follow-up (PMCF) (MDCG 2020-7). This regular updating ensures that the assessment always reflects the current state of the art and clinical evidence.An up-to-date, high-quality CER is therefore a key prerequisite for the conformity assessment procedure, CE marking, and obtaining market approval in the EU.Would you like to learn more about clinical evaluation? Then feel free to download the free white paper Guide to Creating a Clinical Evaluation in Accordance with the Medical Device Regulation (MDR) or take part in our mini-course “Clinical Evaluation”. Or book an initial consultation with Ms. Leistner.

What is the significance of the state of the art in clinical evaluation?

The state of the art plays a central role in clinical evaluation, as it serves as a benchmark for assessing the safety, performance, and clinical benefits of a medical device. According to the EU Medical Device Regulation (MDR EU 2017/745), manufacturers must demonstrate that their product complies with the current state of the art, i.e., that it meets the applicable safety and performance requirements and is at least as safe and effective as comparable products on the market.The “state of the art” refers to the state of development of advanced procedures, processes and technologies that have proven to be scientifically sound, tested and accepted in practice. It is not defined by a single document, but is derived from a variety of information sources, including scientific literature, guidelines from professional associations, standards (e.g., ISO, EN) and recognized regulatory requirements.In clinical evaluation, the state of the art serves as a basis for comparison with the company’s own product: it helps to define relevant performance parameters, risk profiles, and clinical endpoints. This enables manufacturers to objectively assess whether their product corresponds to the current state of knowledge and development or even offers improvements.In addition, the state of the art forms the basis for risk assessment and the definition of clinical follow-up measures (PMCF).If you have questions about a clinical evaluation or have received feedback on a clinical evaluation from your notified body, please take a look at our Deficiency-Analysis. Or take a look at our Deficiency-Checklist, which compiles feedback on clinical evaluations from real conformity assessment procedures.

What role does risk management play in the clinical evaluation?

Risk management is closely linked to clinical evaluation under the EU Medical Device Regulation (MDR EU 2017/745) and forms its safety-related backbone. Both processes pursue the same goal: to ensure safety throughout the entire life cycle.According to ISO 14971, manufacturers must systematically identify, evaluate, control, and document all potential risks associated with the development, manufacture, and use of a product. This risk analysis provides an important basis for clinical evaluation – in particular for assessing whether the clinical benefits of the product outweigh the remaining risks.Clinical data is used in the clinical evaluation to confirm or, if necessary, correct these risk assessments. For example, unexpected side effects, new safety information from market surveillance, or results from post-market clinical follow-up (PMCF) activities (MDCG 2020-7) may give rise to a reassessment of the risks.The feedback between risk management and clinical evaluation is a continuous process: findings from clinical practice are continuously incorporated into the risk analysis, while risk management in turn influences the focus of the clinical evaluation. This close interlinking ensures that safety and performance data are always up to date and that regulatory requirements are met.Consistently implemented risk management ensures that potential hazards are identified early, minimized, and controlled by appropriate measures. It is therefore a basic requirement for demonstrating safety and for the CE marking of medical devices.If you have questions about a clinical evaluation or have received feedback on a clinical evaluation from your notified body, please take a look at our Deficiency-Analysis. Or take a look at our Deficiency-Checklist, which compiles feedback on clinical evaluations from real conformity assessment procedures.

How often do I need to update my clinical evaluation?

Clinical evaluation is not a one-time event, but a continuous process that accompanies the entire life cycle of a medical device. According to Article 61 of the MDR (EU 2017/745), the clinical evaluation must be regularly reviewed and updated to ensure that all findings on safety, performance, and clinical benefits are always in line with the current state of the art.The frequency of updates depends on the risk class and type of product. For Class IIb and III products and implantable medical devices, an annual update is mandatory. For products in lower risk classes (e.g., Class I or IIa), the interval may be longer, provided that there is no new safety-related data or changes to the product, its intended purpose, or the state of the art.MEDDEV 2.7/1 Rev. 4 describes:The clinical evaluation shall be actively updated:when the manufacturer receives new information from post-market surveillance (PMS) that has the potential to change the current evaluation;if no such information is received, then– at least annually if the product poses significant risks or is not yet well established; or– every 2 to 5 years if the product is not expected to pose significant risks and is well established – in this case, justification must be provided.Updates are particularly necessary when new clinical data from post-market clinical follow-up (PMCF) (MDCG 2020-7), vigilance reports, scientific publications, or technological developments become available. This information must be critically evaluated and, if necessary, integrated into the Clinical Evaluation Report (CER) and the risk management system. An update is also always necessary when the state of the art, the intended purpose, the design, or the clinical risk-benefit profile of the product changes.The aim is to continuously confirm the clinical evidence and ensure that the benefits outweigh the risks, even during ongoing operation. A well-documented update strategy strengthens traceability vis-à-vis notified bodies and regulatory authorities – and protects manufacturers from regulatory risks in the long term.Regular revisions ensure that clinical data, PMS and PMCF results, and new scientific findings are integrated. This keeps the clinical evaluation compliant, up-to-date, and robust, which is a key requirement for CE marking and long-term market access.If you have questions about a clinical evaluation or have received feedback on a clinical evaluation from your notified body, please take a look at our Deficiency-Analysis. Or take a look at our Deficiency-Checklist, which compiles feedback on clinical evaluations from real conformity assessment procedures.

What is PMCF (post-market clinical follow-up)?

Post-market clinical follow-up (PMCF) is a central component of the clinical evaluation process under the Medical Device Regulation (MDR, EU 2017/745). It describes the systematic collection and evaluation of clinical data after a medical device has been placed on the market in order to continuously confirm its safety, performance, and clinical benefits in practical use.PMCF is therefore not a one-time event, but an ongoing process that ensures that the product continues to meet the current state of the art and that no new risks or side effects arise. The aim is to identify possible long-term effects or application errors at an early stage and to incorporate them into the ongoing clinical evaluation (CER) and risk management system.PMCF activities are specified in a PMCF plan (see MDCG 2020-7), which is part of the technical documentation (Annex XIV, Part B MDR). This describes which data sources are used (e.g., registry data, literature searches, user surveys, or own clinical trials), how the data is evaluated, and which measures are derived from the results.The results of the PMCF are included in the PMCF report (see MDCG 2020-7) and form an important basis for the regular updating of the Clinical Evaluation Report (CER).A consistently implemented PMCF strengthens the evidence base of a medical device and is crucial for long-term compliance with the MDR.If you have questions about a clinical evaluation or have received feedback on a clinical evaluation from your notified body, please take a look at our Deficiency-Analysis. Or take a look at our Deficiency-Checklist, which compiles feedback on clinical evaluations from real conformity assessment procedures. Or book an initial consultation with Ms. Leistner.

What is PMS (post-market surveillance)? And how does it differ from PMCF?

Post-market surveillance (PMS) is a key element of the MDR (EU 2017/745) and describes the systematic collection, analysis, and evaluation of data on a medical device after it has been placed on the market. The aim of PMS is to continuously monitor the safety, performance, and quality of the product and to ensure that it continues to meet the essential requirements of the MDR.An effective PMS system enables the manufacturer to identify and evaluate trends, side effects, or risks at an early stage and, if necessary, to initiate corrective or preventive actions (CAPA). To this end, vigilance reports, user feedback, service reports, literature data, and results from PMCF activities, among other things, are evaluated.The difference between PMS and PMCF lies in the focus and depth of data collection: While PMS is a higher-level monitoring system that takes all data sources into account, PMCF is an integral part of PMS – but with a specific focus on clinical data. PMCF thus serves to actively confirm the clinical safety and performance of the product in practical use, while PMS collects, evaluates, and documents all product-related information.A structured PMS system is a prerequisite for regularly updating the clinical evaluation, risk management, and technical documentation.If you have questions regarding a Clinical Evaluation or have received feedback from your Notified Body, feel free to review our Deficiency-Analysis service.You may also consult our Deficiency-Cecklist, which compiles real feedback on Clinical Evaluations from conformity assessment procedures, or book an initial consultation with Ms. Leistner.

What should I do if I receive a Deficiency Report for the Clinical Evaluation?

A Deficiency Report is issued by a Notified Body or a Competent Authority when the submitted Clinical Evaluation Report (CER) or the related documentation is incomplete, unclear, or non-compliant with the Medical Device Regulation (MDR, EU 2017/745).The purpose of such a report is not to reject the product but to enable correction and resolution of identified deficiencies.The first step is a thorough analysis of the issues raised in the Deficiency Report.Common findings include insufficient clinical data, missing justifications for equivalence, inadequate risk assessments, or a lack of reference to the state of the art.It is essential to respond to each comment in a traceable, evidence-based, and timely manner.In practice, a structured action plan is recommended, typically including the following steps:Assessment of the identified deficiencies with respect to their relevance for safety and performance.Update of the Clinical Evaluation (e.g., through additional literature searches, new PMCF data, or refined rationales).Documentation of all changes and preparation of a clear response matrix addressing the Notified Body’s comments.Transparency and traceability are key—both in communication and documentation.Manufacturers should demonstrate that they understand the MDR requirements and are proactively working to establish a robust evidence base.If you have questions regarding a Clinical Evaluation or have received feedback from your Notified Body, feel free to review our Deficiency-Analysis service.You may also consult our Deficiency-Cecklist, which compiles real feedback on Clinical Evaluations from conformity assessment procedures, or book an initial consultation with Ms. Leistner.

Ask Dr. Zommer (😎)

Your MDR Question.
Answered Clearly.

Do you have a question about the MDR, Clinical Evaluation, PMS, PMCF, CER, deficiencies, or technical documentation?

Simply submit your question anonymously using the form below. Dr. Leistner will answer selected questions on this page with clear, practical, and scientifically sound explanations.

Your question will remain anonymous.

You only need to provide your email address if you would like to be notified when an answer has been published.

How "Ask Dr. Zommer" Works

1. Submit Your Question

Describe your question as clearly and specifically as possible. The more details you provide, the more helpful and relevant the answer can be.

2. Stay Anonymous

Your question will be published without your name or any personal information. Please do not include any confidential company, product, or patient information in your question.

3. Receive an Answer

Selected questions are answered regularly on this page. If you would like, we can notify you by email as soon as an answer to your question has been published.

Latest Answers to Your Questions

What Information Should Be Included in the “Quantitative Data” Section of the SSCP?

Hello Dr. Zommer Team,

I am currently preparing our SSCP and do not fully understand the section on “Quantitative Data.”

Answer:

Hello,

This is another interesting topic because it represents an important connection between different processes and documents within medical device documentation. Let’s go through the entire section step by step.

The passage in MDCG 2019-09 SSCP – Section 4.1 Quantitative Data begins with:

“The definition of risk includes the probability of occurrence of harm. Therefore the information in the SSCP on risks shall also include quantifications. This information can be sourced from the clinical evaluation report where an updated examination of qualitative and quantitative aspects of clinical safety is available, with clear reference to the determination of residual risks and side-effects.”

This passage explains that a SSCP (Summary of Safety and Clinical Performance) should include quantitative information because, by definition, the concept of risk includes the probability that harm may occur.

It also states that this information should be taken from the Clinical Evaluation Report (CER), which should contain both qualitative and quantitative assessments of clinical safety.

This is a very abstract and complex statement. Hidden within it is a reference to the benchmarking process in the CER. The Clinical Evaluation establishes quantitative acceptance criteria for safety. One example could be the complication rate of medical devices used during surgical procedures.

In another Dr. Zommer article, I discuss benchmarking in Clinical Evaluation in greater detail, so you may also want to take a look at that topic.

Let’s now examine the next section:

“It should also be clarified in the SSCP whether quantitative data on side effects or residual risks relate to clinical data that were obtained proactively, for example from a structured prospective follow-up study of the device itself, or if the expected frequencies come from a systematic review of the scientific literature. It should be disclosed in the SSCP if data from spontaneously reported incidents or serious incidents are used as one of the sources for estimating quantitative data on side-effects or residual risks, in which case significant under-reporting needs to be considered.”

The SSCP should explain the source of the quantitative data and whether the data were collected by the manufacturer through a clinical investigation or obtained from a literature review.

If the data are not collected proactively but instead originate from incident reports or other safety data sources, the possibility of underreporting must be considered.

Clinical study data are collected proactively and systematically because documentation is integrated into the study process and reporting requirements are mandatory for study participants and investigators.

Incident reporting, on the other hand, does not involve a systematic assessment after every use or application of a device to determine whether an issue occurred. Only reported incidents are captured.

As a result, the number of documented incidents may be lower than the actual number of events that occurred. Therefore, rates and probabilities derived from such data have limitations and must be interpreted while considering the possibility of underreporting.

Practical Tip

Separate your quantitative data into Clinical study data and PMS data. The benchmarks for the clinical study data can be derived from the CER (see the corresponding Dr. Zommer article on benchmarking).

The PMS data and associated probabilities can be derived from your trend reporting according to Article 88, as this process specifically focuses on the occurrence frequencies observed during Post-Market Surveillance.

The guidance continues:

“A relation to time should also be included when presenting the quantitative data, for example during five or ten years of use from implantation, or adverse events per 100 patient-years for implantable devices with constant hazards, etc. The quantitative data and the relation to time should always be presented together.

To use tabulated lists for the presentation of side-effects and residual risks with quantitative data and a relation to time, may enhance the readability.”

To make meaningful statements about the probability of occurrence, the rates must always be linked to a specific time period.

Examples for devices used during surgical procedures could include:

Revision rate after 6 months
Complication rate within the first 3 months after surgery

This approach can be applied effectively to both clinical study data and PMS data.

The last part of the guidance states:

“In the part of the SSCP that is intended for patients, residual risks and side-effects should be explained and quantified in a way that patients and lay persons can understand. A statement should be included about how potential risks have been controlled or managed, and also a statement on what to do if the patient believes that he/she is experiencing side-effects related to the device or its use.”

This section is largely self-explanatory.

The objective is to ensure that patients and other laypersons can understand how the information is presented. They should also receive clear guidance on what actions to take if they believe they are experiencing side effects related to the medical device or its use.

Conclusion

A well-structured Clinical Evaluation and robust documentation of trend reporting in accordance with Article 88 are important prerequisites for fulfilling these SSCP requirements. The inclusion of a clear time reference for quantitative data and a patient-friendly presentation of the information are equally important.

I hope this helps clarify the topic and answers your question.

Why Do I Need Clinical Data for All Indications and Target Patient Populations?

Dear Dr. Zommer Team,

My consultant told me that I need clinical data for all indications and target patient populations. However, I cannot find any clear reference to this requirement in the MDR.

Answer:

Yes, that is actually correct. However, the MDR does not state this requirement explicitly, but rather implicitly, which is why it can easily be overlooked at first.

Let’s take a closer look together.

In Annex XIV, Part A of the MDR, it is required that the Clinical Evaluation Plan contains a: “precise specification of the intended target groups with clear indications and contraindications.”

At this point, the requirement is simply that the patient populations and indications are clearly defined.

The requirement for clinical data becomes apparent a few points later within the same section. It states that the plan must also include: “a non-exhaustive list and specification of parameters to be used to determine, based on the current state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device.”

If you are having difficulties with benchmarking, you may also want to look at the other Dr. Zommer questions. Benchmarking is discussed in a separate article as well.

This means that benchmarks must be established to validate the benefit-risk ratio. The MDR explicitly requires this to be done for the different indications. From this requirement, it can be concluded that clinical data should also be available for all indications in order to compare them against the defined benchmarks.

Although the target patient population is not explicitly mentioned here, the same conclusion can be drawn from this requirement. The benefit-risk ratio must be acceptable for the various intended purposes. This means that it must be demonstrated that the device is safe and performs as intended in all intended uses, and therefore also within every patient population. Since this demonstration can only be achieved through clinical data, clinical data should also be available for each patient population.

This interpretation is also reflected in MDCG 2020-13. The assessment template used for reviewing Clinical Evaluations explicitly asks in Section E whether clinical data exists for the intended patient population: “Who is the intended patient population? Does the clinical evidence support this?”

Further conclusions can be drawn from MDCG 2020-1, the guidance document on the Clinical Evaluation of software-based medical devices. Although the document focuses on software, the underlying principles can be applied to all medical devices.

In Section 4, within the discussion of Clinical Performance, the guidance directly asks whether all indications and target populations are supported by clinical data: “Does the data support the intended use, indications, target groups, clinical claims and contraindications?”

In the Background section, the following statement can also be found: “Each indication and claimed CLINICAL BENEFIT that is part of the intended purpose should be assessed individually and have the supporting CLINICAL EVIDENCE.”

This clearly demonstrates that each indication must be assessed individually. The same principle is reflected in the requirements for the Summary of Safety and Clinical Performance (SSCP).

MDCG 2019-09, which provides guidance on the SSCP, states the following in Section 5, “The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up”: “A description of the benefit-risk assessments related to safety and performance for each indication claimed by the manufacturer, including information to address benefit-risk issues of interest to specific patient populations, if applicable.”

At the latest, when preparing the SSCP, it becomes apparent that the clinical data should cover all indications and target patient populations.

Practical Tip

Present your clinical data in a structured manner according to indications and target populations. This provides a clear overview and makes it immediately obvious that supporting evidence exists for all intended uses and patient groups.

What If There Is Not Enough Clinical Data?

If there is insufficient clinical data to demonstrate safety and performance for all indications and target populations, the corresponding claims must be restricted.

This requirement is stated very clearly in MDCG 2020-6 (Section 6.5 e). Although this guidance focuses on the clinical evidence requirements for legacy devices, the principle applies to all medical devices: “If there is not sufficient supportive clinical evidence with regard to the declared intended purpose including the indications and claims as appropriate, manufacturers shall narrow the intended purpose of the device under evaluation until it is supported by the available clinical evidence.”

In other words, if the available clinical evidence does not adequately support all intended indications, claims, or patient populations, the intended purpose must be narrowed until it is fully supported by the available clinical data.

I hope this answers your question and provides some guidance on how to interpret these requirements.

Why Do Similar Devices Need to Be Included in the Clinical Evaluation?

Dear Dr. Zommer Team,

I’m wondering why Similar Devices play such an important role in the Clinical Evaluation. We have our own clinical data and no equivalent devices, so why do we still need to identify Similar Devices? The MEDDEV and the MDR hardly mention Similar Devices at all.

Answer:

What Are Similar Devices and Why Are They Needed?

That is correct. In MEDDEV 2.7/1 Rev. 4, which is still partially relevant, the term “Similar Device” appears only twice, and the term is also not mentioned in Annex XIV of the MDR.

At first glance, there also seems to be no specific guidance on Similar Devices. Somewhat unexpectedly, however, relevant information can be found in MDCG 2020-5: Clinical Evaluation – Equivalence; A Guide for Manufacturers and Notified Bodies.

Definition: What Are Similar Devices?

This guidance also provides a definition of Similar Devices:

“The term ‘similar devices’ may be understood as devices belonging to the same generic device group. The MDR defines this49 as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics”

MDCG 2020-05

Section 5, Use of Similar Data, explains how data from Similar Devices can be used.

What Are Similar Devices Used For?

According to the guidance, data from Similar Devices is relevant for the following purposes:

Ensuring that the risk management system is comprehensive by identifying relevant hazards and clinical risks.
Understanding the state of the art, the natural course of disease and alternative available treatment options.
Helping to define the scope of the clinical evaluation, by identifying any design features in similar devices that pose special performance or safety concerns.
Provide input for clinical investigation design or post-market clinical follow-up design, and the post-market surveillance system.
Identification of relevant and specified clinical outcome parameters for the intended clinical benefits, based on the published clinical data pertaining to the similar device(s).
To define minimum requirements for a quantified clinical benefit that is considered clinically relevant, and/or to identify acceptable occurrence rates of risks and adverse events.

MDCG 2020-05

Although this guidance is not legally binding, many Notified Bodies treat it as an expected requirement.

What Information About Similar Devices Should Be Included?

Now that we understand what Similar Devices are and why they are used, it is equally important to understand what information should be documented about them.

The first indications can be found in MDCG 2020-13: Clinical Evaluation Assessment Report Template.

In Section C – Previous Generations of the Device and Similar Devices (if applicable), the guidance includes the following instruction:

“Verify that the manufacturer has provided:

..
an overview of identified similar devices available on the Union or international markets, where such devices exist, including length of time on the market, sales etc”

MDCG 2020-13

Initially, this requires a general overview of Similar Devices together with relevant market information.

Additional guidance can be found in MDCG 2020-7: Post-Market Clinical Follow-up (PMCF) Plan Template; A Guide for Manufacturers and Notified Bodies.

Although this document focuses on the PMCF Plan, it provides valuable insight into the information that Notified Bodies consider relevant regarding Similar Devices and which therefore should also be included in the Clinical Evaluation.

According to Section E, the following information should be provided for each Similar Device, preferably in tabular format:

The following items of each equivalent and/or similar devices would be at least provided, in a table format:

Product name of equivalent / similar device
Intended purpose
Intended users
Intended patient population
Medical condition
Indication
Reference to clinical data evaluation in the CER (date, version and location in the text)

MDCG 2020-7

How Is the Use of Similar Devices Implemented in Practice?

We now have the basic framework and understand both the required information and the role that Similar Devices play in the Clinical Evaluation.

As mentioned above, MDCG 2020-5 describes the purposes for which Similar Device data can be used. MDCG 2020-13 further explains how this can be implemented.

Connection to Risk Management

Section C of MDCG 2020-13, under Safety, states:

“ If relevant, briefly summarise any significant complaint, trends or vigilance issues associated with earlier device iterations, which may be equivalent or similar devices, and explain whether or not they have any impact on the clinical evaluation assessment.”

MDCG 2020-13

This directly relates to the first purpose described in Section 5 of MDCG 2020-5:

“Ensuring that the risk management system is comprehensive by identifying relevant hazards and clinical risks.”

Connection to the State of the Art

Similar Devices also play a role within the State of the Art section.

The guidance states:

“Briefly describe how benchmarks for safety and performance have been identified by the manufacturer in terms of the state of the art. Benchmarks will normally be based on aggregate data from several devices considered to have acceptable performance (e.g. systematic reviews or registry analysis); if individual devices are selected as benchmarks for safety and performance, a suitable rationale should be provided.”

MDCG 2020-13

This directly supports the final two purposes described in MDCG 2020-5:

Identification of relevant and specified clinical outcome parameters for the intended clinical benefits, based on the published clinical data pertaining to the similar device(s).
To define minimum requirements for a quantified clinical benefit that is considered clinically relevant, and/or to identify acceptable occurrence rates of risks and adverse events.

Practical Tip

This is how we implement Similar Device analysis in our Clinical Evaluations, and the approach has proven successful in numerous MDR conformity assessments for a wide variety of medical devices and Notified Bodies.

In addition to performing a structured State of the Art (SOTA) search, we also conduct a dedicated Similar Device search.

First, we introduce the identified Similar Devices within the Clinical Evaluation together with the information described above. We then search for each product’s trade name in two scientific literature databases.

The searches are performed without applying filters, ensuring that no potentially relevant data is excluded and that every possible residual risk can be identified.

We also search the same trade names in all relevant safety databases.

Ideally, this includes the safety databases of every country where the Similar Devices are marketed. Since the countries of sale are not always fully known, we alternatively search the safety databases of the countries in which the device under evaluation is marketed.

All identified incidents, field safety corrective actions, recalls, and other relevant safety information are incorporated into our safety analysis and compared against the risk management documentation and the Instructions for Use (IFU).

I hope this provides a helpful initial overview.

Otherwise, I would be delighted to welcome you to the next Q&A Session on 7 September, where I can explain the topic in more detail.

What are Benchmark Values?

Dear Dr. Zommer Team,

I received the following deficiency and I’m not quite sure how to address it:

“No benchmark values for the missing outcome parameters have been identified for either of the listed indications.”

How should I approach this?

Answer:

What Are Threshold Values and Benchmarks?

There are several terms used for this concept, such as benchmarks or acceptance criteria. Some readers may also be familiar with the concept of threshold values from technical validation.

In general, the purpose is to define the criteria that must be met to demonstrate the safety and performance of a medical device.

In the context of a Clinical Evaluation, this specifically means defining the clinical safety and performance values that the device is expected to achieve. These target values should be derived from the State of the Art (SOTA) section of the Clinical Evaluation.

An Example: Bone Implants

There are also several terms used for the measurement itself, including Clinical Outcome Parameter, Clinical Endpoint, and their respective translations.

Typical clinical endpoints for implants include:

Complication rates
Revision rates
Mobility scores used to evaluate the performance of a medical device

If we use complication rate as an example, a threshold value could be:

Complication rate below 3% after 6 months

It is important to remember that threshold values must always consist of a measurable clinical parameter combined with a specific numerical value.

Regulatory Requirements for Benchmarking

A useful starting point is Annex XIV of the MDR, which outlines the required contents of the Clinical Evaluation Plan (CEP).

The Clinical Evaluation Plan must include, among other things:

Specification of the methods to be applied for examining the qualitative and quantitative aspects of clinical safety, with clear reference to the determination of residual risks and side effects.
A non-exhaustive list and specification of the parameters used to determine, based on the current state of medical knowledge, the acceptability of the benefit-risk ratio for the various indications and intended purposes of the device.

From the perspective of the Clinical Evaluation, these are highly demanding requirements for the CEP.

The concept of benchmarking is embedded within the requirements concerning:

the methods applied to assess the quantitative aspects of clinical safety, and
the parameters used to determine the benefit-risk ratio.

A more explicit reference can be found in MDCG 2020-13 – Clinical Evaluation Assessment Report Template:

This guidance clearly states that benchmark values must be derived from the State of the Art (SOTA). Ideally, these benchmarks should be based on aggregated data from several Similar Devices, rather than relying on a single device whenever possible.

Ask Dr. Zommer (😎)

Your MDR Question.
Answered Clearly.

How "Ask Dr. Zommer" Works

1. Submit Your Question

2. Stay Anonymous

3. Receive an Answer

Latest Answers to Your Questions

Contact

Business services

Information

Ask Dr. Zommer (😎)

Your MDR Question. Answered Clearly.

How "Ask Dr. Zommer" Works

1. Submit Your Question

2. Stay Anonymous

3. Receive an Answer

Latest Answers to Your Questions

Contact

Business services

Information

Our free Newsletter

Our free Newsletter

Jetzt neu im MEC // ABC Onlineshop

Your MDR Question.
Answered Clearly.