Active Implantable Medical Device

Community-wide regulation of medical devices commenced with the introduction of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Two further base directives followed that cover all other medical devices The Medical Devices Directive 93/42/EEC and The In Vitro Diagnostics Directive 98/79/EC. All three base directives are similar in content and structure. However, it should be noted that, in addition to dealing with the particular subject matter, the Medical Devices Directive and the In Vitro Diagnostics Directive also contained amendments to the previous device directives. The Medical Devices Directive amended articles in the Active Implantable Medical Devices Directive, while the In Vitro Diagnostics Directive amended articles in the Medical Devices Directive. 

The subcategories, active implantable medical devices and in vitro medicai devices are further defined as ... 

As a general rule, clinical data are required as evidence to support conformity with the requirements of the Active Implantable Medical Devices (AIMD) and the Medical Device (MD) directives with regards to safety and effectiveness under the normal conditions of use, evaluation of undesirable side effects, and the acceptability of the benefit/risk ratio. Risk analysis should be used to establish key objectives that need to be addressed by clinical data, or alternatively to justify why clinical data are not required (mainly for Class I devices). The risk analysis process should help the manufacturer to identify known (or reasonably foreseeable) hazards associated with the use of the device, and decide how best to investigate and estimate the risks associated with each hazard. The clinical data should then be used to establish the safety and effectiveness of the device under the intended use conditions, and to demonstrate that any of the residual risks are acceptable, when weighed against the benefits derived from use of the device. 

Active Implantable Medical Devices Directive 90/385 EEC Article 8 (Competent Authority Vigilance procedure), Annex II 3.1 (manufacturer s vigilance and reporting duties)... 

Directive 90/385/EEC on active implantable medical devices ( AlMDs ) came into force on 1 January 1993 and is mandatory from 1 January 1995. This covers all powered implants or partial implants that are left in the human body, such as a heart pacemaker. 

Katsarava et al. (4) prepared biodegradable hydrogels, (III), consisting of epoxy-containing poly(ester amides), which were used as implantable medical devices for delivery of biologically active agents. 

Before implantation several in vitro tests were performed. For evaluation of a possible toxic reaction, we investigated the material and the whole devices in vitro with cell culture methods. Direct contact and extraction tests with a mouse fibroblasts cell line (L 929) and a neuroblastoma cell line (neuro-2-a) were performed according to the international standard ISO 10993 ( Biological Evaluation of Medical Devices ). The materials and devices showed no toxicity, i.e. no significant differences in membrane integrity of the cell membranes, mitochondrial activity and DNA synthesis rate. The neuro-2-a cell line is so sensitive that even small changes in process technology are detectable. The flexible polyimide structures proved to be non toxic. 

Medical devices are used for a variety of functions in humans. This review elaborates on the types of tests used to evaluate biocompatibility of the interactions between man-made medical devices and host tissues and organs. The outcome of the response depends on the site of implantation, the species of the host, the genetic makeup of the host, the sterility of the implant, and the effect the device has on biological processes. Biological processes involved in host tissue responses to implantable medical devices reflect activation of a series of cascades that require blood proteins or other components found in the blood. 

Active implantable medical device directive (AIMD) 90/385/EC... 

The main requirement imposed on all polymer biomaterials applied in medicine is a combination of their desired physicochemical and physicomechanical characteristics with biocompatibility. Depending on particular applications, the biocompatibility of polymers can include various requirements, which can sometimes be contradictory to each other. Thns, in the case of artificial vessels, drainages, intraocular lenses, biosensors, or catheters, the interaction of the polymer with a biological medium should be minimized for the rehable operation of the corresponding device after implantation. In contrast, in the majority of orthopedic applications, the active interaction and fusion of an implant with a tissne is required. General requirements imposed on all medical polymers consist in non-toxicity and stability. 

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