T-015-003 Clinical Evaluation Report_YYYY_nnn

Table of contents

• Scope
• Summary
• Scope of the Clinical Evaluation
  • Manufacturer contact details
  • Medical device description and specification
  • Clinical Benefits, Outcome Parameters
  • Claims foreseen by the manufacturer
  • Physical and chemical description
  • Incorporation of medicinal substances, tissues or blood products
  • Mechanical and physicochemical characteristics
  • Other characteristics
  • Device pictures, drawings and/or schemes
  • Technologies used
  • Intended application of device
  • Applicable standards
  • Available options
  • Clinical Safety, Methods for Analysis
  • Benefits and risks. Acceptability of Benefit-Risk-Ratio and undesirable side-effects
  • Risk Analysis and minimization and management of side effects and other risks
• Type of evaluation of the device
• Clinical Background, Current Knowledge, State of the Art
  • Clinical Background & Current Knowledge
  • Literature Search strategy
• Device equivalence
• Data generated and held by the manufacturer
  • Technical and pre-clinical data generated and held by us
  • Clinical data generated and held by us
• Clinical Data
  • Clinical Data From Literature
  • Appraisal of clinical data
  • Clinical Data from Clinical Study Databases
  • Clinical Data From Adverse Event Databases
  • Analysis of the Clinical Data
• Post-Market Activities
• GAP analysis
• Conclusions
• Date of the Next Clinical Evaluation
• Qualification of the Responsible Evaluators
• References
• Dates and signatures
• Record signature meaning
• Template signature meaning

Scope

The Clinical Evaluation Report states the clinical benefits and safety characteristics of the device, based on clinical data. It is the output of the T-015-001 Clinical Evaluation Plan.

This clinical evaluation report serves as evidence of conformance with certain General Safety and Performance Requirements pursuant to EU Regulation 2017/745 (MDR), Annex I.

Specifically, the following requirements were evaluated as part of this report:

• Chapter 1 (General Requirements), sections 1 and 8
• Chapter 2.8 (Software Devices), section 17
• Chapter 3 (product information), section 23.4

Summary

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Executive summary. This section should summarize the benefit/risk profile in the intended target groups and medical indications, and the demonstration of acceptability based on the state of the art in the medical fields concerned.

Scope of the Clinical Evaluation

Manufacturer contact details

	Manufacturer data
Legal manufacturer name
Address
SRN
Person responsible for regulatory compliance
E-mail
Phone
Fax

Medical device description and specification

	Product information
Product or trade name
Model and type
Product version
General description of the device
Intended purpose
Intended users
Basic UDI-DI
Intended patient population
Medical condition(s)
Indications
Contraindications
Warnings
List and description of any variants and/or configurations coverred by this plan
List of any accessories covered by this plan
Certificate number (if available)
EMDN code(s)
Class
Classification rule

Clinical Benefits, Outcome Parameters

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If our website claims that our device cures back pain in 50% of patients after 14 days, here's the place to list that claim and show explain how we'll prove it.

Claims that have not been stated so far (e.g., in the IFU) are described below and sorted according to their meaning for performance and safety. In this clinical evaluation, it was determined that the claims are sufficiently supported by clinical data.

Performance-related product claims:

• Claim 1, e.g., diagnosis for better treatment decision (performance)
• Claim 2, e.g., xy % accuracy, xy % sensitivity, xy % specificity

Claims foreseen by the manufacturer

Clinical performance claims

• Similar performance in comparison with similar devices analyses in preclinical data.
• Design based on harmonised standards.
• Absence of known adverse events.
• Acceptable benefit/risk ratio.
• Clinical performance confirmation by clinical data (included PMCF).

Clinical safety claims

• Clinical safety validated by similar devices.
• Design based on harmonised standards.
• Absence of known adverse events.
• Acceptable benefit/risk ratio.
• Clinical safety confirmation by clinical data (included PMCF).

Physical and chemical description

Incorporation of medicinal substances, tissues or blood products

Mechanical and physicochemical characteristics

Other characteristics

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Such as sterile, non-sterile, radioactive, etc.

Device pictures, drawings and/or schemes

Technologies used

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Whether the device is based on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology. Description of innovative aspects of the device.

Intended application of device

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Indicate if single use/reusable, invasive/non-invasive, implantable, duration of use or contact with the body, organs or body fluids, maximum number of repeat applications.

Applicable standards

Available options

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Description of available therapeutic/ management/ diagnostic options, historical context and developments, summary of advantages and disadvantages of the different options.

Clinical Safety, Methods for Analysis

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Describe our safety parameters, i.e., which things should our product fulfil so that we consider it safe? And our methods, i.e., how will we prove that our product fulfils those safety parameters? A method could be a literature search for past studies, but we could additionally do a Post-Market Clinical Follow-Up to double-check whether that's actually true for our device.

The methods used to evidence the medical device clinical safety are based on preclinical and clinical data analysis, and the acceptability of the benefit/risk ratio derived from this analysis.

We have a risk management plan in place (GP-013 Risk management) to perform the risk assessment and create the required T-013-003 Risk management report according to the EN ISO 14971:2019 to evaluate all the known and foreseeable risks related to the product.

Safety-related product claims:

• Claim 1, e.g., temporary worsening
• Claim 2, e.g., placebo effect

Benefits and risks. Acceptability of Benefit-Risk-Ratio and undesirable side-effects

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To consider:

• Benefit/risk profiles and limitations in relation to the different clinical forms, stages, and severities of the medical conditions and in relation to different target populations. Description of the benefits and risks (nature, extent, probability, duration, frequency).

• Types of users. Diverging opinions of professionals as to the use of the different medical options. Unmet medical needs.

• After we've defined our benefits and safety parameters, which combination of those is acceptable to us?

• In the case of most software devices (and apps), we'll probably have subtle benefits (e.g., better disease management, early detection of relapses) while low safety concerns (e.g., disease progression unlikely, not killing anyone). Thus, we must define criteria under which the benefit-risk profile is acceptable.

Risk Analysis and minimization and management of side effects and other risks

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Copy-paste our Risk Management Report summary here. This is to prove that our medical device is safe.

Type of evaluation of the device

The preclinical and clinical evaluation is based on the analysis of scientific literature currently available and the state of the art itself, and also the demonstration of equivalence of the device.

Clinical Background, Current Knowledge, State of the Art

Clinical Background & Current Knowledge

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Describe the clinical context of the disease we're treating. How are patients currently treated? Which symptoms do they have, which diagnostic modalities are being used to establish a diagnosis, which treatment options exist? What are the benefits and drawbacks of current treatment options?

We can start with a definition of the disease and describe details about epidemiology, aetiology, pathophysiology, investigation and diagnosis.

Include a section with the similar devices found in the market and their characteristics (the table below can be used as a guideline).

Similar devices

	Device under evaluation	Similar Device 1	Similar Device 2	Similar Device 3
Name
Website
Origin
System
Founding year
Mission
Value proposition
Conditions
1nd USP
2nd USP
3rd USP
Keywords
Product
What services they offer
CE mark
Classification under MDR
Product features
System components
Hardware requirement

Literature Search strategy

A thorough, non-biased, objective and systematic literature assessment of the current state of the art and scientific publications has been performed with the objective to identify possible adverse effects of similar devices and to justify the need for the device PRODUCT to be placed on the market. The literature search strategy is based on two scope areas: preclinical and clinical data evaluation.

Data sources

The evaluation of data is based on a critical and analytical assessment of the available literature. The different sources utilized are:

The preclinical data evaluation is carried out through:

• Applicable and/or harmonized standards, according to the Technical File.
• National and international institutions and medical devices regulatory bodies webs:
  • The Spanish Agency for Medicines and Medical Devices (AEMPS): https://www.aemps.gob.es/
  • The International Medical Device Regulators Forum (IMDRF): http://imdrf.org/safety/safety.asp
  • MedTech Europe: https://www.medtecheurope.org/
  • The European Commission:
    • https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
    • https://ec.europa.eu/info/policies/public-health_en
  • The US Food and Drug Administration (FDA): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  • The Cybersecurity and Infrastructure Security Agency (CISA): https://www.cisa.gov/cybersecurity
  • The European Union Agency for Cybersecurity (ENISA): https://www.enisa.europa.eu/
  • The Notified Body Operations Group (NBOG): https://www.nbog.eu/
• Other manufacturers’ similar devices websites.
• State of the art publications in renowned journal databases.
• Information generated by the manufacturer.

Clinical data:

• Renowned journal databases to support scientific validity:
  • PubMed: https://pubmed.ncbi.nlm.nih.gov/
  • Wiley Online Library: https://onlinelibrary.wiley.com/
  • Springer Link: https://link.springer.com/
  • Science Direct: https://www.sciencedirect.com/
  • Google Scholar: https://scholar.google.es/
• Clinical trials registry platforms to identify relevant investigational studies:
  • The WHO International Clinical Trials Registry Platform: https://www.who.int/clinical-trials-registry-platform/the-ictrp-search-portal
  • Clinical Trials: https://clinicaltrials.gov/

Search filters

When using the search tool of specific websites or when searching in journal databases, at least the first NUMBER results are considered for their further evaluation. If the same scientific publication appears under different search characteristics, the repeated source is ignored and the following source is analysed instead. The scientific and clinical publications are already sorted out by relevance. Moreover, a time filter (last XX years) is applied in order to ensure that the most recent information is evaluated. Relevant citations referenced in the scientific and clinical literature already selected from the previous sources might also be considered for evaluation.

Research questions and keywords

The technical documentation of PRODUCT as well as the state of the art is used to develop the clinical research questions and keywords. The method PICO is chosen to help breaking down into four components the research questions. These identify the key problem of the patient, what treatment or tests are available for the patient, what alternative treatment or tests are being considered (if any) and what is the desired outcome to promote or avoid.

• P = Patient Population: it describes the most important characteristics of the patient. This may include the primary problem, disease, or co-existing conditions.
• I = Intervention, prognostic factor or exposure: it describes the main intervention, prognostic factor, or exposure.
• C = Comparator: it describes the main alternative to compare with the intervention. This can be different devices, tests or placebo. Sometimes the clinical question may not always have a specific comparison.
• O = Outcomes: it describes performance and safety a) What intervention wants to accomplish, measure, improve or affect. This can be to relieve or eliminate the symptoms or reduce the number of adverse events. b) Currently known risks or evidence on safety of the intervention or comparators.

Database search steps

The defined research keywords are used and the search filters are applied in the clinical data sources as it follows:

Step 1: Use PICO to formulate the search strategy.

• PICO search terms

  		Selectet terms
  # 1	Patient population	XXX AND (XXX OR XXX OR XXX)
  # 2	Intervention	(XXX AND (XXX OR XXX OR XXX)) OR (XXX AND (XXX OR XXX OR XXX))
  # 3	Comparator	“XXX” OR “XXX” OR “XXX”
  # 4	Outcomes	“XXX” OR “XXX” OR “XXX” OR “XXX” OR “XXX” OR “XXX”

• PICO search strategy

Description

Patient population AND Intervention AND Comparator AND Outcomes (Performance OR Safety)

Scheme

# 1 AND # 2 AND # 3 AND # 4

Search

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Describe de combination of terms used for the search

Step 2: Search parameters

• Type of trials: randomized controlled trials, meta-analysis and clinical trials.
• Publication time: last XX years.
• Species: humans.
• Number of publications: first NUMBER results of the first page.

Additionally it is required to look at search details to look for contraindications and adverse events reported, meaning that "contraindication" OR "adverse event" should be considered in the search parameters established.

Description

• Patient population AND Intervention AND Comparator AND Outcomes (Performance OR Safety)
• # 1 AND # 2 AND # 3 AND # 4
• Filters: type of trials, publication time and species.

Complete search strategy

(XXX AND (XXX OR XXX OR XXX)) AND ((XXX AND (XXX OR XXX OR XXX)) OR (XXX AND (XXX OR XXX OR XXX))) AND (“XXX” OR “XXX” OR “XXX”) AND (“XXX” OR “XXX” OR “XXX” OR “XXX” OR “XXX” OR “XXX”)

Filters: clinical trials, randomized controlled trials and meta-analysis, last XX years and humans.

Device equivalence

As described at the corresponding Device equivalence section of the GP-015 Clinical evaluation procedure, the equivalence table from the Guideline MDCG 2020-5 is used to identify the supporting data to demonstrate device equivalence. We place emphasis on the differences between PRODUCT and a marketed device rather than the similarities. In line with the MDR 2017/745 requirements, we consider the following characteristics to claim device equivalence:

1. Technical Characteristics (add a separate row for each of the assessed characteristics)	Device 1 (under clinical evaluation) Description of characteristics and reference to specifying documents	Device 2 (marketed device) Description of characteristics and reference to specifying documents	Identified differences or conclusion that there are no differences in the characteristic
Device is of similar design			1.1
Used under similar conditions of use			1.2
Similar specifications and properties including software algorithms			1.3
Uses similar deployment methods where relevant			1.4
Has similar principles of operation and critical performance requirements			1.5

Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR a description of the impact on safety and or clinical performance (use one row for each of the identified differences in characteristics, and add references to documentation as applicable)	Clinically significant difference Yes / No
1.1
1.2

2. Biological Characteristics (add a separate row for each of the assessed characteristics)	Device 1 (under clinical evaluation) Description of characteristics and reference to specifying documents	Device 2 (marketed device) Description of characteristics and reference to specifying documents	Identified differences or conclusion that there are no differences in the characteristic
Uses the same materials or substances in contact with the same human tissues or body fluids			(The characteristic must be the same for the demonstration of equivalence) 2.1

Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR a description of the impact on safety and or clinical performance (use one row for each of the identified differences in characteristics, and add references to documentation as applicable)	Clinically significant difference Yes / No
2.1

3. Clinical Characteristics (add a separate row for each of the assessed characteristics)	Device 1 (under clinical evaluation) Description of characteristics and reference to specifying documents	Device 2 (marketed device) Description of characteristics and reference to specifying documents	Identified differences or conclusion that there are no differences in the characteristic
Same clinical condition or purpose, including similar severity and stage of disease			3.1
Same site in the body			(The characteristic must be the same for the demonstration of equivalence) 3.2
Similar population, including as regards age, anatomy and physiology			3.3
Same kind of user			(The characteristic must be the same for the demonstration of equivalence) 3.4
Similar relevant critical performance in view of the expected clinical effect for a specific intended purpose			3.5

Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR a description of the impact on safety and or clinical performance (use one row for each of the identified differences in characteristics, and add references to documentation as applicable)	Clinically significant difference Yes / No
3.1
3.2

Summary

In the circumstance that more than one non-significant difference is identified, provide a jsutification whether the sum of differences may affect the safety and clinical performance of the device.

For every single characteristic incorporated in the table, scientific justification must be elaborated to show that there is no clinically significant difference in the safety and performance of PRODUCT. For the identification of characteristics that may affect safety and for the assessment of equivalence regarding safety, we implement a risk-based approach.

Both favorable and unfavorable data from PRODUCT as well as from the devices for which equivalence can be demonstrated must be identified. This data may come from:

• Scientific and clinical literature
• Common specifications
• Harmonized standards
• Other established technical specifications

All this data progresses to data appraisal and analysis in order to evaluate whether they are providing sufficient clinical evidence for the purpose of confirmation of conformity with the applicable GSPR.

Data generated and held by the manufacturer

Technical and pre-clinical data generated and held by us

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To include proof of concept studies, performance tests (verification and validation of the SW)...

Clinical data generated and held by us

The manufacturer has generated the following clinical data, which will be complemented with the data obtained from the activities of the Post-Market Clinical Follow-up (PMCF).

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To include here scientific papers, clinical investigations...

Clinical Data

Clinical Data From Literature

We have compiled all the clinical data from literature at the T-015-002 Pre-clinical and clinical evaluation record.

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Include literature summary here

Appraisal of clinical data

In accordance with the T-015-001 Clinical Evaluation Plan, the acceptance or rejection of each piece of information is determined through the application of the following weighted-based system:

Data characteristics	Methodological quality Q	Relevance, R	Contribution, C	Weighted value, W (W=Q+R+C)	Appraisal data	Notes
Very relevant information in relation with the product and its intended use	30	30	30	W ≥ 70	Accepted	Pivotal data
Relevant information in relation with the product and its intended use	20	20	20	30 < W < 70	Accepted	Other data
Little relevant information in relation with the product and its intended use	10	10	10	W ≤ 30	Rejected	No contribution, rejected

As it is described at the T-015-001 Clinical Evaluation Plan, preclinical data is accepted when it provides comparable technical information of equivalence/similar device on the market or information about similar accessories. On the other hand, preclinical data is rejected when the information is incomplete, insufficient, or irrelevant.

Scientific publications are accepted when the study design is adequate, and when they provide information that clarifies whether the use of PRODUCT is necessary, safe, and advantageous over other alternatives on the market. That is, when the intended use, the target patient population, or the target user group matches PRODUCT’s. On the other hand, scientific publications are rejected when their content do not discuss the topic of interest, when the conclusions are inconsistent or there are misinterpretations, when there is a lack of information on basic aspects, or when the information is inaccessible or repetitive.

Clinical Data from Clinical Study Databases

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To list all the clinical data we got from studies (clinical trials.gov, WHO).

Clinical Data From Adverse Event Databases

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To list all the clinical data we got from vigilance databases which matched our appraisal criteria (BfArM, MAUDE, FDA, Medical Device Recall, EUDAMED (when applicable)).

If the product has not been introduced to the market, we investigate the adverse events for equivalent device.

Analysis of the Clinical Data

According to the T-015-001 Clinical Evaluation Plan, we analyze the data accepted from the appraisal in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits and possible adverse events.

Requirement on safety

Tips to complete this section

To analyse:

• Whether there are special design features that pose special safety concerns (e.g. presence of medicinal, human or animal components) that where identified in the device risk management documentation and that required evaluation from a clinical perspective, and whether these have been adequately addressed.

• Whether the risks identified in the risk management documentation and literature have been adequately addressed. Whether all the hazards and other clinically relevant information (e.g. clinical precautions for reduction of risks, clinical management of risks) have been identified appropriately.

• Whether the safety characteristics and intended purpose of the device requires training of the end-user or other precautions, if users foreseen are adequate, if training requirements and other precautions are described in the IFU.

• Whether there is full consistency between current knowledge/ the state of the art, the available clinical data, the information materials supplied by the manufacturer, and the risk management documentation for the device.

We also consider in this section the cybersecurity of the product, if required.

More details in Appendix A7.1 of MEDDEV 2.7.1. rev.4.

Requirement on acceptable benefit/risk

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We must include in this section:

• A summary of the total experience with the device, including estimated numbers and characteristics of patients exposed to the device in clinical investigations, PMCF, from other user experience, and in the market; duration of follow-up.
• The nature, extent/severity, probability/frequency, duration of benefits to the patients and of undesirable side-effects and other risks.
• For each aspect of the intended purpose, whether the benefit/risk profile including its uncertainties or unanswered questions is compatible with a high level of protection of health and safety, corresponding justifications.
• An evaluation of the accetability of the benefits and risks for all medical conditions and target population covered by the intended purpose, and whether limitations need to be considered for some populations and/or medical conditions.

More details in Appendix A7.2 of MEDDEV 2.7.1. rev.4.

Requirement on performance

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In this section we must clarify if:

• The devices achieve their intended performances during normal conditions of use, analysed
• The intended performances are supported by sufficient clinical evidence.

According to the MDCG 2020-1, for medical device software (MDSW), we analyse the three key elements to consider when compiling clinical evidence:

• Valid clinical association: the extent to which the MDSW’s output, based on the inputs and algorithms selected, is associated with the targeted physiological state or clinical condition defined in the intended purpose. (Literature search, proof of concept, equivalence)
• Technical performance: ability to accurately, reliably and precisely generate the intended output, from the input data. (Verification and validation activities)
• Clinical performance: ability to yield clinically relevant output in accordance with the intended purpose. (Papers, equivalence, benefits)

Requirement on acceptability of undesirable side-effects

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In this section we must include:

• Whether the data available is of sufficient amount and quality for the detection of undesirable side-effects and their frequency, limitations of the data, description of gaps, uncertainties or unanswered questions, and assumptions.
• Whether the undesirable side-effects are acceptable and corresponding justifications.

More details in Appendix A7.4 of MEDDEV 2.7.1. rev.4.

Post-Market Activities

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In this chapter we summarise our PMS/ PMCF activities and we will refer to our documents and records related:

• GP-007 Post-market surveillance
• T-007-001 Post-market surveillance (PMS) plan
• T-007-002 Post-market clinical follow-up (PMCF) plan
• T-007-003 PSUR
• T-007-004 PMS evaluation report
• T-007-005 PMCF evaluation report

If this is our initial certification, the reports may be empty, but, at least, we will include here the kind of data we'll be tracking to make sure that our claims of clinical benefits and safety are actually true.

GAP analysis

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In this section we must analyse if, after all the assessed data, we have validated and evidenced the clinical safety and performance together with the benefit/risk ratio, or if there is any aspect that has not been covered.

We must also relate the analysis with the market experience, if the product was in the market before this report, or with the literature, SOTA and equivalence demonstration.

Additionally, we should complete this analysis with the PMCF activities planned to continue with the product/s follow up.

Conclusions

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To include all the conclusions extracted from the clinical evaluation, whether the clinical data shows that our goals (benefit/ performance and safety) are fulfilled.

Do not forget to include that the information provide to the users has been also validated (labelling, IFU)

Complete the table below with the conclusions obtained that validate that the GSPR detected have been considered and mitigated.

General requirements	Applicable? (YES/NO)	Related hazard or hazardous situation risks	Conclusion that validates risk management and mitigation
GSPR 1: The product shall achieve the intended performance and be suitable for its intended purpose. The product shall be safe and effective and shall not compromise the clinical condition or the safety of patients.
GSPR 2: Eliminate or reduce risks as far as possible without adversely affecting the benefit-risk ratio.
GSPR 3: Establish, implement, document and maintain a risk management system. Establish and document a risk management plan, identify and analyze the known and foreseeable hazards, estimate and evaluate the risks, eliminate or control the evaluated risks, and evaluate the impact of information from the production phase and post-market surveillance system and amend control measures if necessary.
GSPR 4: Manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. eliminate or reduce risks as far as possible through safe design and manufacture, take protection measures in relation to risks that cannot be eliminated, provide information for safety and, when appropriate, training to users. Inform users of any residual risks.
GSPR 5: Eliminate or reduce risks related to use error.
GSPR 6: The characteristics and performance shall not be adversely affected during the lifetime of the product.
GSPR 7: The characteristics and performance shall not be adversely affected during transport and storage.
GSPR 8: All known and foreseeable risks shall be acceptable when weighed against the evaluated benefits to the patient and/or user.
GSPR 9: For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood.
GSPR 10: Chemical, physical and biological properties.
GSPR 11: Infection and microbial contamination.
GSPR 12: Products incorporating a medicinal product absorbed by the human body.
GSPR 13: Products incorporating materials of biological origin.
GSPR 14: Construction of products and interaction with their environment.
GSPR 15: Products with a diagnostic or measuring function.
GSPR 16: Protection against radiation.
GSPR 17: Electronic programmable systems.
GSPR 18: Active products and products connected to them.
GSPR 19: Particular requirements for active implantable products.
GSPR 20: Protection against mechanical and thermal risks.
GSPR 21: Protection against risks posed by products supplying energy or substances.
GSPR 22: Protection against risks posed by medical products intended by the manufacturer for use by lay persons.
GSPR 23: General requirements regarding the information supplied by the manufacturer. Information on the label. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’). Information in the instructions for use.

Date of the Next Clinical Evaluation

Considering the device risk analysis as well as the establishment of the device within the current state of the art, a new preclinical and clinical evaluation of the available literature will be performed every year using the same weighted-based system. Occasionally, it will be actively updated when we receive new information from PMS and PMCF that has the potential to change the current evaluation of the benefit/risk profile and the clinical performance and clinical safety of PRODUCT.

Qualification of the Responsible Evaluators

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Describe following the scheme below the qualification of all the responsible evaluators that participate in this clinical evaluation performance.

Name 1

• Job position:
• Education:
• Experience with the product/process/technology:
• Training in risk management and other applicable:
• Valuation: QUALIFIED
• Date:
• Approved by: Name 2 (Job position) (Signature above)

The clinical team CVs are documented as independent files and saved in the corresponding evidences folder for the CER placed at INCLUDE FOLDER LINK. The CVs are updated and revalidated yearly and archived as: YYYY_MM_Name_Surname_CV.

Additionally, the T-015-007 Declaration of interest Clinical evaluation team of each evaluator is signed and placed at the INCLUDE FOLDER LINK.

References

Dates and signatures

Approval an acceptance of the present report by representing the manufacturer of the medical device/s covered by it:

Name	Position	Signature
Alfonso Medela	Technical Responsible

Record signature meaning

• Author: JD-004 Author name
• Review: JD-003 Reviewer name
• Approval: JD-005 Approver name

Template signature meaning

info

Delete this section when you create a new record from this template.

• Author: JD-004 María Diez
• Review: JD-005 Mr. Alfonso Medela
• Approval: JD-001 Ms. Andy Aguilar