2 Scope
Applicable to CE-marked products.
3 Related Documents
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 Determination of the intended use of the product
6.2 Classification according to the intended use of the product in accordance with the requirements of the MDD 93/42/EEC, amended by 2007/47/EC Appendix IX, applying the intra-product sub-procedure.
6.3 When the product is a new type of medical device or Class III device, implantable or long-term traumatic Class IIa and IIb medical devices
Mechanisms shall be clinically evaluated according to the requirements of MDD 93/42/EEC, amended by 2007/47/EC Appendix, and the requirements of ISO14155.
6.4 For medical devices that do not fall under 6.3 and are already in common 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 The hazards identified in the clinical risk analysis should be addressed and the views expressed in the written report supported.
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6.5.3 Documentation may also use unpublished scientific data, such as results of small-scale trials including in vitro and animal testing, technical
technical standards compliance information, etc. Documents and records of market information may also be part of the documentation.
6.5.4 Opinions of qualified physicians or specialists in the relevant field may also be used to demonstrate the safety and performance of the device, and the written opinions of such specialists
should be signed and dated by the author.
6.6 Requirements for Clinical Assessment Reports Involving Serious Hazards.
6.6.1 Clinical assessments involving serious hazards shall be reported in writing unless otherwise documented.
6.6.2 The report shall be prepared by a person qualified in the relevant field.
6.6.3 The report shall be accompanied by scientific literature and shall list the publications to which it is applied, with copies.
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.
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6.6.6 The report shall 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 shall clearly evaluate the equivalence of the literature to the product evaluated.
6.6.8 The report should confirm that the performance described in the clinical risk analysis is consistent with the performance of the product and that it will fulfill its intended purpose.
6.6.9 The report shall include the hazards identified, the risks, and the safety measures for the patient, medical personnel, 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 shall give a theoretically based extrapolated view.
6.6.12 The report shall include a bibliography of the literature it cites.
6.6.13 Statements dealing with the use of the product, instructions, precautions, efficacy, and side effects shall be
consistent with the instructions for use of the product.
6.6.14 Laboratory test results, proof of biocompatibility in accordance with the relevant technical standards are also included in the report.
6.7 Final report of the clinical evaluation
The documentation 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 content relevant to the clinical investigation,
in particular:
● Normal use, intended purpose, indications and precautions.
● Product performance
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 the information gathered from all clinical assessments.
● 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.