4 Principles for the valuation of the biological evaluation of materials and medical devices

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1 1 Purpose This checklist supplements the process description device certification and regulates the details and approach for the evaluation of the biological evaluation of medical devices in the context of the risk analysis. 1.1 Scope While checking the essential requirements according to Annex I of EC Medical Directive 93/42/EEC it has to be evaluated if in the determinations of points 7.1 and 7.2 the biological effects have been considered sufficiently. In the context of the evaluation of the device design of devices of risk class III or with evaluation samples of technical documentation of devices of risk class IIa and IIb the biological evaluation of medical devices has to be reviewed, if need be. The necessity is being determined in the context of the evaluation of the essential requirements. 2 Definitions and explanations see EN ISO Evidence The results of the evaluation have to be presented accordingly in the report. It can be referenced to the documented results in the checklist within the evaluation report, in case that the checklist is being use. 4 Principles for the valuation of the biological evaluation of materials and medical devices The following points have to be considered in the evaluation of the available technical documentation: 1. For the biological evaluation of a medical device all materials have to be considered that have contact with body tissue. Materials are all synthetic or natural polymers, metals, alloys, ceramics or other non viable substances including devitalizing tissues that are being used as medical device or part of such. 2. The type of the contact hast o be determined and correspond with the intended use of the medical device 3. The duration period of the contact has to be determined and correspond with the intended use of the medical device. 4. The frequency of the contact has to be determined and correspond with the intended use of the medical device. 5. The degree of the contact has to be determined and correspond with the intended use of the medical device 6. On base of points 1-5 the biological effects that have to be considered have to be determined. These depend on the type, degree, frequency and duration period of the body contact with the medical device or with parts thereof. 7. The appropriate test methods for the evaluation of the biological effects have to be determined. It has to be justified which evaluations result for the individual materials according to the principles for biological evaluation according to DIN EN ISO In case that the performance of evaluations of the biological effects that have to be considered need to be relinquished, it has to be justified comprehensible and documented with evidence why this is possible. (i.e. use of standardized materials for the intended use (implant steel according to ISO ) or analog conclusions). 9. The biological evaluation of materials and the dedicated effects have to be evaluated in the risk analysis and have to correspond to the records in the essential requirements Annex I 7.1 and With medical devices that do not fall under one of the categories named in DIN EN ISO , the evaluated should be performed according to the general principles that are contained in DIN EN ISO In case that medical devices fall under several categories, the evaluation provided for each concerned category should be considered. Attention: biocompatibility evaluation have to be done on the final product! Version: / 5

2 5 Responsibilities and authorities 5.1 Lead auditor The lead auditor is responsible for the evaluation and estimation of the QM system regarding the customer s system documentation, the referenced standards and regulations of the Directive 93/42/EEC, He carries responsibility for the work of the audit team and the compliance to the DQS processes. In case that the lead auditor is not the expert, he acknowledges the evaluation of the biological invenstigation by the expert without reservation. 5.2 Experts He is responsible for the technical evaluation and with regards to content of the product and procedure specific aspects of the QM system. Therefore the evaluation of the design documentation, particularly the biological evaluation of the medical devices in the context of the risk analysis falls to him. 6 Further applicable documents Assessor s guideline supplement Medical Device Directive 93/42/EEC DIN EN ISO revision december 2009 Biological evaluation of medical devices part 1: evaluation and testing identical with ISO : 2003 Version: / 5

3 Classification of the medical device by Biological effect Evaluation of the biological evaluation Type of body contact Category Contact Contact period A Short term ( 24 h) B longer (> 24 h bis 30 Tage) C permanent (> 30 Tage) Cytotoxicity Allergization Irritation or intracutaneous reactivity Systemic toxicity (acute) Subcutaneous and subcronical tixicity Genotoxicity Implantation Hemocompatibility Cronical toxicity Carcinogenicity Reproduction / developmental toxicity Biodegradation Remark / reference Body surface Contacting from the outside with the inside of the body Implantable medical device Skin B O O O C O O O Mucosa B O O O O O C O O O Injured or endangered B O O O surface C O O O O O O O B O O O O O Vascular circulatory system, indirectly C O O O O O O O O tissue/ bones/ B O O O O O O O Dentin C O O O O O O O O O O O Circulating B O O O O O O O O blood Tissue/bones Blood C O O O O O O O O O O B O O O O O O O C O O O O O O O O O O O O O B O O O O O O O O C O O O O O O O O O O Version: / 5

4 Requirement Are the materials with body contact clearly identified? Has the mode of body contact been assigned to the manterials? Has the time of body contact been determined? Reference, statement and if need be description of the non-conformity evaluation Do the statements to the above questions match with the intended use of the device? Are all evaluations to be thought of named? Is the evidence for the performance of the evaluations to be thought of available? Have the evaluation been performed by therefore qualified laboratories? (Is the laboratory / inspection site accredited or is other qualification evidence available?) Have standardized materials been used for the itended use? Have the applicable standards been named? Are the standards harmonized and mandated or rather are they equivalent to the accepted best available technology? Are the justifications for non-performance of an evaluation comprehensible and documented? Have the biological evaluation to be thought of been considered in the risk analysis? Have all evaluations been prepared/approved by qualified experts? Is there an overall evaluation available? Final evaluation Version: / 5

5 Has the biological evaluation been performed sufficiently comprehensible? (note short statement) date: auditor s / expert s signature Version: / 5