Risk Management Plan Form

Risk Management Plan

For

[Device Name]

Manufacturer Name: [Manufacturer name]

Document Number: RMP-ZZZZ(-XXX)

Revision: Y

Introduction

Risk management policy

Implementing a risk management process in accordance with EN ISO 14971:2019 ensures a systematic and structured approach to identifying, estimating, evaluating, and controlling risks associated with a medical device. This process is applied throughout the entire device lifecycle, from design and development to obsolescence, enabling the continuous identification of potential hazards and hazardous situations, the implementation of risk control measures, and the verification of their effectiveness.

Executive management plays a critical role in supporting risk management activities by allocating sufficient resources necessary for the effective implementation of the risk management process. Through this commitment, top leadership defines the criteria for risk acceptability, as outlined in this risk management plan. These criteria are derived from applicable national and international standards and take into account the generally acknowledged state of the art, as well as other relevant industry information.

The methodologies used in risk assessment are primarily based on EN ISO 14971, as well as other relevant standards such as EN ISO 10993-1 (biocompatibility), EN 62304 (software lifecycle processes), EN 62366-1 (usability engineering), and ISO/TR 24971 (guidance on risk management application). This list should be reviewed and adjusted as necessary to align with the specific nature of the medical device and applicable regulatory requirements.

Reference documents

Adjust the list of standards, procedures and records as necessary.

Table 1: Reference documents

Document No.	Document Title
	Risk Analysis
	Risk Management Report
	Usability Engineering File
	Device History File
	Device Master Record
	Technical Documentation
	Risk Management Procedure
	Design and Development Procedure
	Post-Market Surveillance Procedure
	Usability Procedure
	Clinical Evaluation Procedure
EN ISO 14971:2019	Medical devices – Application of risk management to medical devices
ISO/TR 24971: 2020	Medical devices – Guidance on the application of ISO 14971
EN 62366-1:2015	Medical Devices Part 1: Application for Usability Engineering to Medical Devices
EN ISO 10993-1:2020	Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
MDR	Medical Devices Regulation (EU 2017/745)

Process overview

The risk management procedures shall be applied in the manner depicted below (adopted from EN ISO 14971):

Figure 1: Representation of the risk management process

Scope of risk assessment

This risk management plan defines the process implemented by [Company Name] (hereafter named [Company short name]) to systematically identify both known and unforeseen hazards, evaluate associated risks, estimate their severity and probability, implement risk control measures, and monitor post-production activities.

The hazards identified through this process are related to the intended use of [Device Name] (hereafter name [Device short name]) across its entire product lifecycle, such as product design, manufacturing, or operational hazards.

This risk management plan and all related risk management activities are conducted in accordance with the risk management procedure (see Section 1.2).

This risk management plan does not cover project-related risks or business operational risks, such as project timelines or financial risks.

Product references

Table 2: Device Models

Manufacturer Name:		[Company short name]
Device Family Name:		[Device short Name]
Model Number	Description	Basic UDI-DI

Device description

Include the description as reported in the IFU or TD File

Device intended use

Include the intended use, indication for use, contra-indications, complications as reported in the IFU.

Responsibilities

The following individuals are involved in the risk management process of [Device short name]:

Table 3: Individual Responsibilities

Roles/Representatives	Individual Names	Functions/Responsibilities
Top Management Team (1)		Supports the risk management process by providing resources for the completion of these activities.
Engineers (2)		Provide technical expertise.
Operations (3)		Provide manufacturing expertise.
Supply Chain (4)		Provide expertise with the controls of supply chain.
Marketing (5)		Provide customer-related requirements.
Regulatory Affairs (6)		Assure compliance with standards and regulatory requirements.
Quality Assurance (7)		Responsible for the definition, implementation and control of risk management activities according to the applicable quality system procedures. Responsible for the implementation of post-market surveillance activities.
Validation (8)		Provide expertise in validation of manufacturing processes and methods.
Medical or Clinical Expert (9)		Ensure the review and approval of benefit – risk analysis.
XXX

To be customized as needed.

The involvement of the various roles described above in the risk management process is summarized in the table below:

Table 4: Accountability and support

Document	Risk management process	(1)	(2)	(3)	(4)	(5)	(6)	(7)	(8)	(9)
Risk management plan	Commitment for resources and personal qualifications
	Policy for establishing criteria for risk acceptability
	Intended use and identification of characteristics related to the safety of the medical device
Risk analysis	Identification of hazards and hazardous situations
	Estimation/Evaluation of risk(s)
	Risk control option analysis
	Implementation of risk control measures
	Verification activities
	Residual risk estimation and evaluation
	B/R analysis of individual risk(s)
	Risk(s) arising from risk control measures
	Completeness of risk control
Risk management report	Overall residual risk evaluation
	Overall B/R evaluation
	Risk management review
	Production and post-production activities

A: Accountability / S: Support

Product lifecycle

The lifecycle of [Device short name] extends from development through obsolescence. Risk management activities are conducted at each stage to ensure systematic identification, evaluation, control, and monitoring of risks.

During development and transfer to manufacturing, risk management activities are performed in accordance with the design and development procedure and the risk management procedure (see Section 1.2).

During production and post-production, risk management activities are conducted in accordance with the risk management procedure and the post-market surveillance procedure (see Section 1.2).

All risk management activities are documented in the risk management file to ensure traceability and compliance with EN ISO 14971:2019.

The risk management process applies to all stages of the device lifecycle, including but not limited to:

• Design & development
• Manufacturing (including key manufacturing stages such as XXXX – specify critical steps relevant to the device)
• Storage & transportation
• Installation
• Clinical use
• Servicing
• Disposal

Adapt the device lifecycle as necessary.

Qualitative and quantitative characteristics related to safety

Qualitative and quantitative safety characteristics relevant to risk management are evaluated using data sources described in Section 5.1 and the guiding questions from Annex A of ISO/TR 24971:2020, as detailed in Section 5.2.

Risks identified from the assessment of these safety characteristics are mitigated as far as possible through risk analysis, evaluation, and control processes in accordance with EN ISO 14971:2019.

The risk management team systematically identifies known and foreseeable hazards associated with [Device short name], considering:

• Intended use
• Reasonably foreseeable misuse
• Safety characteristics under both normal operating conditions and fault conditions

Source of safety characteristics

A systematic review has been conducted to identify all regulatory sources relevant to safety characteristics that must be considered during the risk management process. Traceability between these sources and the risk analysis document will be maintained through iteration references (e.g., #A, #B, etc.).

To ensure comprehensive hazard identification and analysis of reasonably foreseeable sequences or combinations of events that may lead to a hazardous situation, the following sources will be evaluated:

• From Post-Market Surveillance database publicly available: (#A)
  • US MAUDE database
  • EUDAMED
  • TPLC US database
  • XXX
• Literature Search database (#B)
  • PubMed
  • XXX
• Applicable standards including:
  • XXX (#C)
  • XXX (#D)
  • XXX (#E)
  • XXX (#F)
  • XXX (#G)
  • XXX (#H)

Safety characteristics from Annex A ISO/TR 24971

A systematic review of all questions from Annex A of ISO/TR 24971:2020 has been conducted to assess their applicability to [Device short name]. Each applicable question is then analyzed during the risk assessment to determine the hazards and hazardous situations relevant to the device.

To ensure traceability, the safety characteristics considered in the risk management plan will be linked to the risk analysis document through iteration references (e.g., #1, #2, etc.) as detailed in the following table.

Table 5: Annex A ISO/TR 24971

§	Questions		Applicability
A.2.1	What is the intended use and how is the medical device to be used?
		diagnosis, prevention, monitoring, treatment or alleviation of disease,
		diagnosis, monitoring, treatment or alleviation of or compensation for injury or handicap,
		investigation, replacement, modification or support of anatomy, or a physiological process, or
		control of conception?
		what are the indications for use (e.g. patient population, user profile, use environment)?
		what are the contra-indications?
		does the medical device sustain or support life?
		is special intervention necessary in the case of failure of the medical device?
		can essential performance be impacted in the event of a security breach (performance degradation or loss of availability)?
		can unauthorized access, unauthorized activities, or loss of data affect the medical device safety?
A.2.2	Is the medical device intended to be implanted?
A.2.3	Is the medical device intended to be in contact with the patient or other persons?
		nature of the intended contact (i.e. surface contact, invasive contact, or implantation)
		period of contact
		frequency of contact
A.2.4	What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?
		compatibility with relevant substances;
		compatibility with tissues or body fluids;
		whether characteristics relevant to safety are known;
		is the medical device manufactured utilizing materials of animal origin?
A.2.5	Is energy delivered to or extracted from the patient?
		the type of energy transferred;
		its control, quality, quantity, intensity and duration;
		whether energy levels are higher than those currently used for similar medical devices.
A.2.6	Are substances delivered to or extracted from the patient?
		whether the substance is delivered or extracted;
		whether it is a single substance or range of substances;
		the maximum and minimum transfer rates and control thereof.
A.2.7	Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation?
		the type of process and substance(s) processed (e.g. autotransfusion, dialysis, blood component or cell therapy processing).
A.2.8	Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?
		whether the medical device is intended for single use or re-use packaging;
		shelf-life issues;
		limitation on the number of re-use cycles;
		method of product sterilization;
		the impact of other sterilization methods not intended by the manufacturer.
A.2.9	Is the medical device intended to be routinely cleaned and disinfected by the user?
		types of cleaning or disinfecting agents to be used;
		limitations on the number of cleaning cycles;
		design of the medical device to influence the effectiveness of routine cleaning and disinfection;
		effect of cleaning and disinfecting agents on the safety and performance of the medical device.
A.2.10	Does the medical device modify the patient environment?
		temperature;
		humidity;
		atmospheric gas composition;
		pressure;
		light.
A.2.11	Are measurements taken?
A.2.12	Is the medical device interpretative?
		conclusions are presented by the medical device from input or acquired data
A.2.13	Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?
		Any other medical devices, medicines or other medical technologies involved
		Potential problems associated with such interactions (such as the medical device impacting essential performance of other medical devices via unauthorized access to the medical device)
		Patient compliance with the therapy
A.2.14	Are there unwanted outputs of energy or substances?
		Energy-related factors: noise, vibration, heat, radiation (including ionizing, non-ionizing, ultraviolet/visible/infrared radiation), contact temperatures, leakage currents, electric/magnetic fields.
		Substance-related factors: substances used in manufacturing, cleaning, testing having unwanted physiological effects if they remain in the product.
		Other: discharge of chemicals, waste products, and body fluids.
A.2.15	Is the medical device susceptible to environmental influences?
		operational environment
		transport environment
		storage environment
		light, radiation
		temperature
		humidity, dampness
		vibrations
		spillage, fluids
		power supply
		variations in the power supply
		cooling agent supply
		electromagnetic interference
A.2.16	Does the medical device influence the environment?
		the effects on power and cooling supplies;
		emission of toxic materials;
		the generation of electromagnetic disturbance.
A.2.17	Does the medical device need consumables or accessories?
		essential consumables
		specifications of accessories
		restrictions placed upon users in their selection of accessory
		Availability of spare parts or accessory
A.2.18	Is maintenance or calibration necessary?
		whether maintenance or calibration are to be carried out by the user or by a specialist;
		are special substances or equipment necessary for proper maintenance or calibration?
		how to determine when maintenance or calibration is needed?
		How to verify that calibration is (still) acceptable?
A.2.19	Does the medical device contain software?
A.2.20	Does the medical device allow access to information?
		accessible Ethernet ports, USB ports, serial ports, and removable hard drives.
A.2.21	Does the medical device store data critical to patient care?
		possibility of the data being modified or corrupted, unauthorized access to the data, and the consequences for the patients
A.2.22	Does the medical device have a restricted shelf-life?
		the medical device can deteriorate over time
		storage conditions impact
		primary packaging importance
		communication of the expiry date (by labelling/indicator)
		possible use after the expiry date
		disposal of expired medical devices
A.2.23	Are there any delayed or long-term use effects?
		ergonomic and cumulative effects. Examples could include pumps for saline that corrode over time, mechanical fatigue, loosening of straps and attachments, vibration effects, labels that wear or fall off, long-term material degradation
A.2.24	To what mechanical forces will the medical device be subjected?
		under the control of the user
		controlled by interaction with other persons
		not under the control of the user
A.2.25	What determines the lifetime of the medical device?
		battery depletion
		deterioration of materials/failure of components due to ageing, wear, fatigue or repeated use
A.2.26	Is the medical device intended for single use?
		the medical device self-destruct
		it is obvious that the medical device has been used.
A.2.27	Is safe decommissioning or disposal of the medical device necessary?
		waste products generated during the disposal of the medical device itself
		does the medical device contain hazardous material (e.g. toxic chemical or biological agent)?
		is the material recyclable?
		proper sanitization (removal) of all sensitive data on the medical device
		proper handing and security of the decommissioning data
A.2.28	Does installation or use of the medical device require special training or special skills?
		the complexity and novelty of the medical device and the knowledge, skills and ability of the persons installing, maintaining or using the medical device. This can include training, education, competence assessment, certification or qualification.
A.2.29	How will information for safety be provided?
		whether information will be provided directly to the end user by the manufacturer or will it involve the participation of third parties such as installers, care providers, health care professionals or pharmacists and whether this will have implications for training;
		commissioning and handing over to the end user and whether it is likely/possible that installation can be carried out by people without the necessary skills;
		based on the type and expected life of the medical device, whether re-training or re-certification of operators or service personnel would be required.
A.2.30	Will new manufacturing processes need to be established or introduced?
		application of new or innovative technology
		changes in the scale production
A.2.31	Is successful application of the medical device dependent on the usability of the user interface?
A.2.31.1	Can the user interface design features contribute to use error?
		Factors that should be considered include: control and indicators, symbols used, ergonomic features, physical design and layout, hierarchy of operation, menus for software-driven medical devices, visibility of warnings, audibility of alarms, standardization of colour coding etc.
A.2.31.2	Is the medical device used in an environment where distractions can cause use error?
		Factors that should be considered include:
		the consequences of use error,
		whether the distractions are commonplace,
		whether the user can be disturbed by an infrequent distraction,
		whether repetitive stress can reduce the user’s awareness or attention.
A.2.31.3	Does the medical device have connecting parts or accessories?
		Factors that should be considered include: the possibility of wrong connection, similarity to other products’ connections, connection force, feedback on connection integrity, and over- and under-tightening.
A.2.31.4	Does the medical device have a control interface?
A.2.31.5	Does the medical device display information?
A.2.31.6	Is the medical device controlled by a menu?
A.2.31.7	Is the successful use of the medical device dependent on a user’s knowledge, skills and abilities?
		Factors that should be considered include:
		the user, their mental and physical abilities, skill and training,
		the use environment, ergonomic aspects, installation requirements
		the capability of intended users to control or influence the use of the medical device
		the personal characteristics of intended users that can affect their ability to successfully interact with the medical device.
A.2.31.8	Will the medical device be used by persons with specific needs?
		users with special characteristics, such as disabled persons, the elderly and children, who might need assistance by another person to enable the use of a medical device;
		users having wide-ranging skill levels and differing cultural backgrounds and expectations that could lead to differences in what is considered appropriate application of the medical device.
A.2.31.9	Can the user interface be used to initiate unauthorized actions?
		whether the user interface allows the user to enter an operation mode with restricted access (e.g. for maintenance or special use), which increases the possibility of use error and thereby the associated risks, and whether the user becomes aware of having entered such operation mode.
A.2.32	Does the medical device include an alarm system?
		the application of new or innovative technology and changes in the scale of production. This can also involve changes in contract manufacturing, suppliers and vendors.
A.2.33	In what way(s) might the medical device be misused (deliberately or not)?
		Factors that should be considered include:
		incorrect use of connectors
		disabling safety features or alarms
		neglect of manufacturer’s recommended maintenance
		unauthorized access to the medical device or to medical device functions
A.2.33	Is the medical device intended to be mobile or portable?
		need for grips, handles, wheels or brakes, and the need for mechanical stability and durability.
A.2.34	Does the use of the medical device depend on essential performance?
		e.g., output of life supporting medical devices or the operation of an alarm.
A.2.35	Does the medical device have a degree of autonomy?
		awareness of the user when the medical device with a degree of autonomy generates an error, alarm or failure;
		awareness of the user when intervention in an autonomously performed action is required;
		the ability of the user to intervene in or to abort an action that is performed autonomously; and
		the ability of the user to select and perform proper corrective actions.
A.2.36	Does the medical device produce an output that is used as an input in determining clinical action?
		whether incorrect or delayed outputs can result in direct or indirect risks to patients, e.g. an incorrect diagnosis resulting in delayed or omitted therapy for a patient.

Identification of hazards and hazardous situations

Based on the safety characteristics identified in Sections 5.1 and 5.2, the known and foreseeable hazards associated with [Device short name] will be assessed based on:

• Intended use
• Reasonably foreseeable misuse
• Safety characteristics under both normal and fault conditions

For each identified hazard, the reasonably foreseeable sequences or combinations of events that could lead to a hazardous situation is analyzed. The resulting hazardous situations will be documented accordingly.

The identification of hazards and hazardous situations is systematically recorded in the risk analysis table (see Section 1.2).

Risk acceptability criteria

The risk analysis methodology applied to [Device short name] is based on Failure Modes and Effects Analysis (FMEA). Risk assessment is conducted using severity and likelihood criteria to determine the Risk Priority Number (RPN) ranking.

Definition

The following tables describe the criteria used to identify severity and likelihood of risks.

The definition can be customized as needed.

Table 6: Criteria of severity

Ranking		Definition	Associated harms
4	Critical	Death or loss of function or structure, long-term or irreversible injury	indicate all harms used in the risk analysis for the corresponding severity
3	Serious	Reversible, minor or short-term injury that can be treated via a second intervention.	indicate all harms used in the risk analysis for the corresponding severity
2	Moderate	Reversible, minor or short-term injury that can be treated without a second intervention.	indicate all harms used in the risk analysis for the corresponding severity
1	Minor	No patient injury but can result in discomfort or inconvenience.	indicate all harms used in the risk analysis for the corresponding severity

Table 7: Criteria of likelihood

Ranking		Definition	Likelihood
4	Frequent	Likely to happen, often, frequently Likely to happen several times during the lifetime of the medical device	P >10-4%
3	Occasional	Can happen, but not frequently Likely to occur a few times during the lifetime of the medical device	10-5% < P ≤ 10-4%
2	Remote	Unlikely to happen, rare, remote Not likely to occur during the lifetime of the medical device	10-6% < P ≤ 10-5%
1	Improbable	Extremely unlikely to occur. No known or recorded cases with the subject or similar devices.	P≤10-6%

Justification:

The justification for likelihood estimation should primarily be based on harmonized, national, or internal standards. If relevant standards provide likelihood estimates, these should be the primary reference. If no applicable standards exist, it is recommended to consult guidelines published by recognized professional associations. When neither standards nor guidelines are available, a literature search should be documented. The objective of the literature review is to determine the overall market size for the device type and estimate the likelihood of events based on reported incident frequencies, such as 10⁻⁴ for frequent events. Databases such as TPLC (Total Product Life Cycle) and EUDAMED should be analyzed when available to provide an overview of reported incidents. When no other sources are available, a scientific estimation by a clinician may be considered. This estimation should be supplemented by the manufacturer’s cumulative experience and historical data on the device, as well as expert knowledge related to the device category.

Risk priority number

This section defines the criteria established by top management for determining the acceptability of risk. The assigned RPN is calculated as the product of severity and likelihood. Likelihood may be assessed as a combination of probability and detectability.

If detectability is considered, its methodology must be described in Section 6.1.

Risk estimation is conducted for each hazardous situation identified for [Device short name] and involves evaluating both risk severity and likelihood according to the definitions provided in Section 6.1. In cases where risk estimation cannot be precisely determined due to uncertainties in severity or occurrence, the most critical estimation will be applied based on the state of the art and available knowledge.

Note: Any residual risk will then be assessed in relation to the anticipated benefits, taking into account the inherent uncertainty in risk estimation.

Semi-quantitative risk evaluation matrix

The following matrix will be utilized to assess risk evaluation by determining the level of risk based on the assigned severity and likelihood values.

The color code/levels of risks in the following table needs to be adapted to the device

Table 8: Risk evaluation matrix

	Critical	Serious	Moderate	Minor
Frequent	Level 3	Level 3	Level 3	Level 1
Occasional	Level 3	Level 3	Level 2	Level 1
Remote	Level 3	Level 2	Level 1	Level 1
Improbable	Level 1	Level 1	Level 1	Level 1

The acceptability of risk is determined on a 3-level scale as described in the following table:

Table 9: Risk acceptability level

Level	Definition
1	Low risk, the benefit/risk profile is acceptable. The risk control measures must be implemented as far as possible.
2	Undesirable risk, the benefit/risk profile is uncertain and needs to be further analyzed to justify acceptability. The risk control measures must be implemented as far as possible
3	Intolerable risk, the benefit/risk profile is unacceptable. The risk control measures must be implemented as far as possible.

Justification:

Top management has approved the previous risk acceptability considering the state of the art and experience with the treatment and treatment options of the medical conditions involved with [Device short name].

For the risk acceptability matrix that can be justified based on factual evidence. The following table can be completed.

The risk evaluation matrix has been established based on the following justification:

Table 10: Justification of risk acceptability level

Level	Justification
1	possible justification: the risk level may be justified based on standards, professional guideline, similar devices/alternative treatments, position of clinicians to evaluate the acceptability
2	possible justification: the risk level may be justified based on standards, professional guideline, similar devices/alternative treatments, position of clinicians to evaluate the acceptability
3	possible justification: the risk level may be justified based on standards, professional guideline, similar devices/alternative treatments, position of clinicians to evaluate the acceptability

Risk control measures

Risk mitigation options

Risk mitigation will be achieved through risk control activities to reduce the likelihood and/or severity of harm to an acceptable level. If risks cannot be further reduced, justification must be provided. All risks, including those considered negligible, must be reduced as far as possible (AFAP) while ensuring that the benefit-risk balance remains favorable. Financial factors will not be an influencing element in the decision-making process for implementing these measures.

Risk controls will be implemented following a structured approach:

1. The primary approach to risk control is to prioritize inherently safe design and manufacturing, ensuring that the device is developed and produced in a way that minimizes potential hazards. This can be achieved through design enhancements such as integrating alarms, incorporating fail-safe mechanisms, or modifying the device structure to eliminate risks.
2. When additional risk reduction is necessary, appropriate protective measures will be applied both to the medical device itself and throughout the manufacturing process to strengthen safety. These measures may involve stringent quality control procedures and thorough training programs for production personnel.
3. As a final layer of risk control, safety-related information and user training will be provided to ensure that users understand potential hazards and how to manage them effectively. This includes the use of clear labeling, detailed instruction manuals, and explicit warnings. While this step is essential, it does not reduce the risk estimation but rather informs users of the residual risks and associated safety information (e.g., complications, contra-indications, warnings and precautions).

Once risk control measures have been implemented, a verification process will be carried out to evaluate their effectiveness. This process includes confirming both:

• the correct implementation of the risk control measures, and
• their ability to reduce risk effectively.

Implementation of risk control measures

The implementation of risk mitigation activities will be recorded in the risk analysis table (see Section 1.2), where each document serving as evidence of a risk mitigation activity will be identified. Risk control measures apply to the relevant design outputs generated throughout the product lifecycle, encompassing both the design and development process as well as the post-production phase.

Verification of effectiveness

The verification of effectiveness ensures that the implemented risk control measures have successfully reduced the likelihood and/or severity of risks.

The following methods may be used to verify the effectiveness of risk control measures:

• testing to confirm compliance with applicable harmonized or technical standards,
• testing to ensure the device meets established safety criteria,
• design verification and validation,
• process validation,
• clinical data assessment.

The verification of effectiveness will be documented in the risk analysis table (see Section 1.2).

Residual risk evaluation

After implementing the risk control measures, the likelihood and severity of risks will be reassessed, and the residual risk will be evaluated using the same criteria applied in the initial risk evaluation.

The reassessment and evaluation of residual risk will be documented in the risk analysis table (see Section 1.2).

Benefit-risk evaluation for individual risks

For each identified hazardous situation associated with the [Device short name], a benefit-risk analysis will be conducted using preclinical and clinical data to determine whether the benefits of [Device short name] outweigh each specific residual risk.

If there is insufficient evidence to conclude that the benefits outweigh these residual risks, [Device short name] will:

• be modified to meet the intended requirements,
• not be commercialized, or
• be withdrawn from commercialization.

Documentation of the benefit-risk evaluation for each risk will be included in the risk analysis table (see Section 1.2).

Additionally, [Company short name] evaluates the cumulative impact of all residual risks that may interact, comparing them against the overall benefits of the device.

Undesirable residual risks that may interact are grouped together, and the associated risks are deemed acceptable if:

• all risk control measures have been implemented, evaluated as effective, and further risk reduction is not feasible without compromising device performance or safety.
• the benefits of the device outweigh the combined residual risks for the intended patient population.
• the residual risks can be effectively communicated to and managed by the user, while remaining aligned with regulatory requirements and the state of the art.

Documentation of the benefit-risk evaluation for the cumulative impact of undesirable residual risks will be included in the risk management report (see Section 1.2).

Risks arising from risk control measures

For each risk control measure implemented, an evaluation will be conducted to determine whether it introduces new hazards or impacts existing risk estimations. Any newly identified risks will be assessed, estimated, and managed in accordance with the procedures outlined in this risk management plan.

The findings from this evaluation will be documented in the risk analysis table (see Section 1.2).

Completeness of risk control measures

All risk control activities will be systematically reviewed to ensure they effectively address all identified hazardous situations and that each risk control measure has been fully implemented.

The results of this review will be documented in the risk management report (see Section 1.2).

Overall residual risk

The interactions between risks have been evaluated in Section 7.3, and the groups of interacting risks have been deemed acceptable when compared to the benefits of using [Device short Name].

Additionally, to evaluate the acceptability of the overall residual risk:

• The risk shall be classified according to its maximum risk level, as defined in Table 8: Risk evaluation matrix.
• The benefit of using the device shall be classified as outlined in Table 11: Level of innovation below.

Table 11: Level of innovation

Level	Description	Definition
1	Breaking technology	Device that disrupts existing healthcare technologies with no available alternative.
2	Strong clinical impact	Device of significant interest to healthcare, particularly by demonstrating statistically significant improvements in clinical practice, patient outcomes, and/or providing a new diagnostic strategy in a clinical field.
3	Moderate clinical impact	Device of interest to healthcare, particularly by improving clinical practice, patient outcomes, and/or offering a diagnostic alternative.
4	Unchanged clinical impact	No benefits over existing alternatives.

The following method will be applied to assess the acceptability of overall residual risks compared to the benefits provided by the device:

Table 12: Method of overall B/R evaluation

Max Risk Level	1	2	3
Benefits
1	B/R to be further analyzed by expert review and review of labeling	B/R to be further analyzed by expert review and review of labeling	Unacceptable, The device cannot be marketed or retained on the market
2	B/R to be further analyzed by expert review	B/R to be further analyzed by expert review	Unacceptable, The device cannot be marketed or retained on the market
3	Acceptable with Review of labeling	B/R to be further analyzed by expert review	Unacceptable, The device cannot be marketed or retained on the market
4	Acceptable with Review of labeling	Acceptable with Review of labeling	Unacceptable, The device cannot be marketed or retained on the market

If the evaluation concludes that the overall residual risk is unacceptable relative to the device’s benefits:

• [Company short name] will consider modifications to [Device short name] or its intended use, or
• [Company short name] will not commercialize or will withdraw [Device short name] from the market.

If the evaluation concludes that the overall residual risk is acceptable relative to the device’s benefits, [Company short name] may place or maintain [Device short name] on the market.

The findings of the overall residual risk evaluation will be documented in the risk management report (see Section 1.2).

Method of overall residual risk evaluation

Expert review

The comprehensive benefit-risk analysis will be based on the Clinical Evaluation Report (CER) for [Device short name], conducted by designated experts. Only individuals with the necessary experience and qualifications will assess whether the benefits of the device outweigh its risks.

The CER will determine the acceptability of the overall residual risk associated with the [Device short name] by comparing its clinical benefits against current standards, including similar devices and alternatives. This assessment will take into account:

• Pre-clinical data,
• Clinical investigation and Post-Market Clinical Follow-up (PMCF) data,
• Published literature,
• Clinical experience,
• Post-Market Surveillance (PMS) data.

Additionally, the CER will evaluate whether undesirable side effects are acceptable under normal conditions of use and confirm that residual risks remain compatible with a high level of health and safety protection.

A summary of the B/R analysis, as approved by designated experts, will be included in the Risk Management Report (see Section 1.2).

Review of labeling

In accordance with Annex I, Chapter I, Section 4 and Chapter II, Section 23.4(g) of the General Safety and Performance Requirements (GSPR) under MDR, [Company short name] will ensure that users are informed of any residual risks through the documentation provided with [Device short name]. Contraindications and undesirable side effects will be explicitly disclosed in this documentation.

The overall residual risk evaluation method includes a systematic review of the device labeling to verify:

• consistency of data,
• comprehensiveness of information,
• absence of contradictions.

This review will be documented in the risk management report (see Section 1.2).

Requirements for review of risk management activities

The risk management file of [Device short name] will be reviewed throughout the design control process, as outlined in the design control procedure (see Section 1.2).

During the post-marketing phase, the need to review the risk management activities will be evaluated as part of:

• the continuous post-market surveillance activities according to the methods for obtaining production and post-production information (see Section 9)
• change to [Device short name]’s design or manufacturing

Methods for obtaining production and post-production information

Post-marketing information will be collected through the following activities:

• production-related activities
  • nonconforming product management
  • supplier evaluation
  • supplier audits
  • corrective and preventive actions
• post-production activities
  • post-market surveillance
  • post-market clinical follow-up
  • customer complaints management
  • vigilance activities
  • servicing and maintenance
  • field safety corrective actions
  • customer feedback
  • regulatory surveillance and compliance monitoring
  • clinical evaluation report updates

To be customized as needed.

The collected post-marketing data will be periodically reviewed and may trigger updates to the risk management file for [Device short name] to ensure ongoing compliance and safety when:

• new risks are identified
• existing risks are impacted (change in likelihood or severity)
• continuous benefit-risk ration is affected