LEVERAGE OUR EXPERTISE IN EUROPEAN CLINICAL AND BIOLOGICAL REQUIREMENTS FOR FASTER MARKET APPROVALS
According to MDD 93/42/EEC Annex I “Essential Requirements” clause 6a and Annex X a clinical evaluation must be performed to demonstrate that unexpected side effects do not constitute an unacceptable risk when weighed against the intended performances.
According to MDD Annex X “As a general rule, confirmation of conformity ….. and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio …. must be based on clinical data.”
The new guideline MEDDEV 2.7/1 rev4 (June 2016) provides a description for clinical data generated and held by the manufacturer (section 8.1) or detected by literature search (Appendix A4).
The major difference from the former version of the MEDDEV is that now the number of the “equivalent devices” is limited to one instead of an unlimited number. Also, the revision of the clinical evaluation must be reviewed and determined each year for high risk medical devices and 2-5 years to the other medical devices depending on the risk potential.
Based on all summarized data the UL experts will come to a conclusion if these clinical data are sufficient to show the acceptability of the Benefits vs. Risk profile. If the experts deemed that the clinical data are not significant to show the clinical property regarding the intended use, the indications, the contraindications and side-effects, then at a minimum, a post market follow up study (PMCF) must be performed to investigate long-term effects which are not sufficiently described in the already available clinical data.
If the clinical data, held by the manufacturer as well as found during literature search, are not applicable for the medical device under consideration, because there is no equivalent device identifiable or the medical device is brand new innovative, a clinical trial, in accordance with ISO 14155 must be performed.
UL Experts will support the manufacturer by performing a clinical evaluation according to MEDDEV 2.7/1 rev4 by writing the clinical evaluation or providing a template which fulfil all requirements of the MEDDEV 2.7/1 rev4. For this the UL Team needs the Instructions for use with all information about the indented use, the indications, contraindications, side effects, warnings, the risk management, the biocompatibility evaluation, mechanical evaluations if applicable and already performed clinical data held by the manufacturer. Based on this UL will write a Clinical Evaluation Plan in which the procedure and the medical device data are described. Afterwards the Clinical Evaluation report will be performed in which the relevant clinical data are identified, appraised and analyzed. Finally the experts will perform a conclusion in which they determine if the planned market introduction can be supported without restrictions or if a post market follow up study or even a clinical trial according to ISO 14155 must be performed.
According to the MDD 93/42/EEC Annex I “Essential requirements” Clause 7 and national regulations every medical device manufacturer has to demonstrate that their medical devices will not cause potential biological risks. This applies to medical devices that have direct or indirect contact to the patient’s human body. The standard EN ISO 10993-1 “Evaluation and testing within a risk management process” and the U.S. FDA Guidance “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” (June 2016) give a pathway to achieve this requirements within a risk management process, as part of the overall evaluation and development of each device. UL Medical Solutions will help you to find a reasonable strategy to verify the biocompatibility for your medical device to fulfil the both or either requirement of the EN ISO 10993-1 and FDA guidance as needed. In comparison with the harmonized international standard EN ISO 10993-1 and the FDA Guidance, the FDA requests additional investigations, e.g. material-mediated pyrogenicity.
To avoid unwelcome surprises with the final product to be used for the biological investigations, the material selection should begin during the development process. The selection of material(s) to be used in device manufacture and its biocompatibility evaluation should initially take into account the likelihood of direct or indirect tissue contact and any available information about the materials of manufacture, for example, chemical formulation for each component material, including adhesives, known and suspected impurities, and constituents associated with processing. The device in its final finished form, and possible leachable chemicals or degradation products should be considered for their relevance to the overall biocompatibility evaluation of the device.
The manufacturer should use materials which are well-known to be appropriate for the intended use and assumed to be biocompatible. Depending on the material, the manufacturing process and the intended use, some of the required investigations can be met through literature search and animal testing can be limited.
Based on the results of all performed tests UL experts will write a summarized assessment “Declaration of Compliance” which demonstrates the biocompatibility of the medical device in question. For this statement the UL Team needs information about the intended use, the kind and duration of body contact and the already performed investigations.
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