Medizinproduktezulassung unter MDR - Klinische Daten, Risikomanagement, PMCF & Co.

FAQ

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 XIV
Risk management file in accordance with ISO 14971
Quality 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 product
Information to be provided by the manufacturer
Information on design and manufacture
General safety and performance requirements
Benefit-risk analysis and risk management
Product verification and validation

In 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.

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.

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.

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.

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.

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.

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