Clinical Assessment Program Compilation
Review
Approval
File No. WL-C-004D Start Date 2010.02.10 Page 1 *** 2 pages
1 Purpose
According to the MDD 93/42/EEC, amended by 2007/47/EC Appendix X of the requirements, a clinical evaluation of the product based on the intended use of the product, the intended use of the product, the intended use of the product, the intended use of the product, the clinical evaluation of the product.
2 Scope
Applies to CE-marked products.
3 Relevant files
3.1 MDD 93/42/EEC
3.2 2007/47/EC
4 Definitions
None
5 Responsibilities
R&D is responsible for the collection of clinical information and the clinical evaluation of the product.
6 Operations
6.1 Determine the intended use of the product
6.2 According to the intended use of the product according to the requirements of the MDD 93/42/EEC, amended by 2007/47/EC Appendix IX, the applicable products are categorized by sub-internal programs.
6.3 When the product belongs to a new type of medical device or Class III device, implantable or long-term traumatic Class IIa and IIb medical devices
devices, should be in accordance with the requirements of MDD 93/42/EEC, amended by 2007/47/EC Appendix, and the requirements of the ISO14155 clinical assessment.
6.4 For medical devices that do not fall under 6.3 and are already in general use on the market, a literature search should be conducted to compile the "scientific literature" on the device in accordance with the requirements of MDD 93/42/EEC, amended by Appendix X of 2007/47/EC.
6.5 Requirements for the compilation of scientific literature
6.5.1 should address the hazards identified in the clinical risk analysis and support the views of the written report.
6.5.2 When citing published literature, such literature shall be published in recognized scientific and technical publications, and factors affecting the scientific
validity of the literature include:
● Whether the literature reflects the recognized state-of-the-art
● Whether the authors have backgrounds relevant to the medical device and the medical process
● Impartiality
p> 6.5.3 Unpublished scientific information may also be used in the documentation, such as the results of small-scale trials, including in vitro and animal testing, and technical standards compliance data
Files and records of market information may also be part of the documentation.
6.5.4 Opinions of qualified physicians or specialists in the field may also be used to demonstrate the safety and efficacy of the device, and the written opinions of such specialists
should be signed and dated by the author.
6.6 Requirements for Clinical Evaluation Reports Involving Serious Hazards.
6.6.1 Clinical assessments involving serious harm should be reported in writing unless otherwise documented.
6.6.2 The report should be prepared by a person qualified in the relevant field.
6.6.3 The report should be accompanied by scientific literature and should list the publications to which it applies, with photocopies.
6.6.4 The report shall be directed to the product being demonstrated.
6.6.5 The report should be accompanied by a discussion of the scientific literature with pros and cons.
Clinical Evaluation Program Document No. WL-C-004D
Start Date 2010.02.10
Page ***2 Page 2
6.6.6 The report should include a description of the product, its intended use, its intended purpose, instructions for use of the product, and precautions.
6.6.7 The report should clearly evaluate the equivalence of the literature to the product being evaluated.
6.6.8 The report should confirm that the efficacy described in the clinical risk analysis is consistent with the efficacy of the product and that the intended purpose is achieved.
6.6.9 The report shall include the identified hazards, risks, and safety measures for patients, healthcare workers, or third parties.
6.6.10 The report shall include an assessment of the risk-benefit, which shall demonstrate that the benefits of the product outweigh the disadvantages when used.
6.6.11 The report should give a theoretically based extrapolated view.
6.6.12 The report should include a bibliography of the literature it cites.
6.6.13 The pronouncements dealing with the use of the product, instructions, precautions, efficacy, and side effects should be
consistent with the instructions for use of the product.
6.6.14 Laboratory test results, proof of biocompatibility with the relevant technical standards are also included in the report.
6.7 Final report of the clinical evaluation
The dossier of the clinical evaluation shall include:
6.7.1 The identification of the product, a brief description of the product, which shall adequately address the elements relevant to the clinical investigation,
and in particular:
● Methods of normal use, intended purpose, indications and precautions.
● Efficacy of the product
6.7.2 Purpose of the clinical evaluation.
6.7.3 Methods used for clinical evaluation.
6.7.4 Conclusions
● The results of the evaluation of all the information collected for the clinical assessment.
● Results of the assessment of clinical suitability.
● Evidence that the purpose of the clinical assessment has been achieved.
6.7.5 Other elements to be included
● Evidence that the product complies with mandatory regulatory requirements.
● Results of risk analysis, side effects and expected benefits.
What is a medical device clinical acceptance assessment report?A clinical assessment of a product according to the requirements of MDD 93/42/EEC, amended by 2007/47/EC Appendix X, based on the intended use of the product.
2 Scope
Applies to CE-marked products.
3 Relevant files
3.1 MDD 93/42/EEC
3.2 2007/47/EC
4 Definitions
None
5 Responsibilities
R&D is responsible for the collection of clinical information and the clinical evaluation of the product.
6 Assignment
6.1 Determine the intended use of the product
6.2 According to the intended use of the product according to the requirements of MDD 93/42/EEC, amended by 2007/47/EC Appendix IX, the applicable products are categorized by sub-internal program.
6.3 When the product belongs to a new type of medical device or Class III device, implantable or long-term traumatic Class IIa and IIb medical devices
devices, should be in accordance with the requirements of MDD 93/42/EEC, amended by 2007/47/EC Appendix, and the requirements of the ISO14155 clinical assessment.
6.4 For medical devices that do not fall under 6.3 and are already in general use on the market, a literature search should be conducted to compile the "scientific literature" on the device in accordance with the requirements of MDD 93/42/EEC, amended by Appendix X of 2007/47/EC.
6.5 Requirements for the compilation of scientific literature
6.5.1 should address the hazards identified in the clinical risk analysis and support the views of the written report.
6.5.2 When citing published literature, such literature shall be published in recognized scientific and technical publications, and factors affecting the scientific
validity of the literature include:
● Whether the literature reflects the recognized state-of-the-art
● Whether the authors have backgrounds relevant to the medical device and the medical process
● Impartiality
p> 6.5.3 Unpublished scientific information may also be used in the documentation, such as the results of small-scale trials, including in vitro and animal testing, and technical standards compliance data
Files and records of market information may also be part of the documentation.
6.5.4 Opinions of qualified physicians or specialists in the field may also be used to demonstrate the safety and efficacy of the device, and the written opinions of such specialists
should be signed and dated by the author.
6.6 Requirements for Clinical Evaluation Reports Involving Serious Hazards.
6.6.1 Clinical assessments involving serious harm should be reported in writing unless otherwise documented.
6.6.2 The report should be prepared by a person qualified in the relevant field.
6.6.3 The report should be accompanied by scientific literature and should list the publications to which it applies, with photocopies.
6.6.4 The report shall be directed to the product being demonstrated.
6.6.5 The report should be accompanied by a discussion of the scientific literature with pros and cons.
Clinical Evaluation Program Document No. WL-C-004D
Start Date 2010.02.10
Page ***2 Page 2
6.6.6 The report should include a description of the product, its intended use, its intended purpose, instructions for use of the product, and precautions.
6.6.7 The report should clearly evaluate the equivalence of the literature to the product being evaluated.
6.6.8 The report should confirm that the efficacy described in the clinical risk analysis is consistent with the efficacy of the product and that the intended purpose is achieved.
6.6.9 The report shall include the identified hazards, risks, and safety measures for patients, healthcare workers, or third parties.
6.6.10 The report shall include an assessment of the risk-benefit, which shall demonstrate that the benefits of the product outweigh the disadvantages when used.
6.6.11 The report should give a theoretically based extrapolated view.
6.6.12 The report should include a bibliography of the literature it cites.
6.6.13 The pronouncements dealing with the use of the product, instructions, precautions, efficacy, and side effects should be
consistent with the instructions for use of the product.
6.6.14 Laboratory test results, proof of biocompatibility with the relevant technical standards are also included in the report.
6.7 Final report of the clinical evaluation
The dossier of the clinical evaluation shall include:
6.7.1 The identification of the product, a brief description of the product, which shall adequately address the elements relevant to the clinical investigation,
and in particular:
● Normal method of use, intended purpose, indications and precautions.
● Efficacy of the product
6.7.2 Purpose of the clinical evaluation.
6.7.3 Methods used for clinical evaluation.
6.7.4 Conclusions
● The results of the evaluation of all the information collected for the clinical assessment.
● Results of the assessment of clinical suitability.
● Evidence that the purpose of the clinical assessment has been achieved.
6.7.5 Other elements to be included
● Evidence that the product complies with mandatory regulatory requirements.
● Results of risk analysis, side effects and expected benefits.
What is included in a medical device clinical trial report?According to the "Medical Device Clinical Regulations" (Bureau Decree No. 5), the clinical report should include:
1, general clinical information (types of diseases, the total number of cases and the selection of cases)
2, the clinical trial methodology (including the setup of the control group, if necessary)
3, the statistical methods used and the evaluation method
4, the clinical evaluation criteria<
5. Results of the clinical trial
6. Adverse events and side effects found in the clinical trial and their treatment
7. Analysis of the effect of the clinical trial
8. Conclusion of the clinical trial
9. Indications, scope of application, contraindications and precautions
10. Existing problems and suggestions for improvement
11, responsible for clinical trials of the medical institutions of the clinical trial management department comments
Medical devices where clinicalUndertake clinical trials of medical devices in medical institutions, refers to the State Council Food and Drug Administration in conjunction with the State Council health administrative department recognized the clinical trial of drugs base.
The difference between clinical evaluation and clinical trials of medical devicesClinical evaluation can be based on a literature survey, such as citing the scientific literature to illustrate the effectiveness of a product's components or functions, without the need for clinical testing of their own products. It is less costly.
Clinical trials require specific clinical testing of samples of their own products, the cost is relatively high,
What is the class of clinically validated medical devices
Hello, most of the class II and class III medical devices are required to conduct clinical trials, so your question is too broad, in addition to the General Administration of Food and Drug Administration in our country can be exempted from the provisions of the Medical Device
In addition to the Food and Drug Administration can be exempted from clinical trials of medical devices, are required to clinical trials of the device.
What is the content of the medical device training?Training content:
1, medical device regulatory system;
2, medical device supervision and management of the main measures and important features;
3, the basics of medical device regulation (clinical validation work);
4, adverse reactions to medical devices and the registration program of the technical review of the key points;
5, biological solubility and tissue engineering and products;
5, biological solubility and tissue engineering and products;
5, the medical devices and the medical devices and the medical devices and the medical devices and the medical devices and the medical devices and the medical devices. and tissue engineering and products;
6, passive medical device products and medical device industry status and development trend;
7, electrical safety, X-ray machine;
8, radium therapy devices, respiratory, ultrasound diagnostic devices.
Preparing a clinical evaluation report for a Class II medical device requires comparisons with medical devices of the same species, where to get the information, what is the website?This is all to be produced after a long period of market research and literature search studies, and not just where you find points or others can provide help. Even if there is, but also will not provide you with, after all, is confidential material, and the product is different, the direction of the research objectives and goals are different
Class II medical devices can do clinical?Need, but if how to stipulate can also not do. Article 22 of the Measures for the Administration of Registration of Medical Devices for the record of the first class of medical devices, without clinical trials. Application for registration of Class II and Class III medical devices, clinical trials should be conducted.
One of the following circumstances, can be exempted from clinical trials:
(a) the mechanism of work is clear, the design is finalized, the production process is mature, has been listed in the same variety of medical devices for many years of clinical application and no record of serious adverse events, do not change the routine use;
(b) through the non-clinical evaluation can be proved that the medical device is safe and effective;
(C) through the clinical trials of the same variety of medical devices or clinical use of information obtained by analyzing and evaluating, can prove that the medical device is safe and effective.
Exempt from clinical trials of medical devices catalog by the State Food and Drug Administration to develop, adjust and publish. Not included in the directory of medical devices exempted from clinical trials, through the clinical trials of the same variety of medical devices or clinical use of information obtained by analyzing and evaluating, can prove that the medical device is safe and effective, the applicant can be declared for registration to explain, and submit relevant information.
What are the clinical trial management services for medical devices?Comprehensive medical device clinical trial management services include the following: 1, medical device clinical trial strategy and study design: evaluation of clinical pathways; preclinical assessment; study design and selection of topics 2, medical device clinical trial management: site and investigator selection; enrollment strategy; implementation of the clinical trial 3, post-market clinical trial support: post-market monitoring information analysis; compensation strategy and management; Medical Device Clinical Research and Design Changes