Active Implantable Medical Device Directive

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. 

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

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

Two directives related to medical devices are the Medical Devices Directive (MDD), enacted in 1993 (mandatory as of June 15,1998), and the Active Implanted Medical Devices Directive (AlMDD), effective since 1995. Safety is the primary concern of this system, and as in the United States, there are three classes of risk. These risks are based on what and for how long the device touches, and its effects. Safety issues include electrical, mechanical, thermal, radiation, and labeling. Voluntary standards that address these issues are formulated by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). 

AIMD Active Implantable Medical Devices Directive... 

Borderline cases are considered to be those cases where it is not clear from the outset whether a given product falls under Medical Device Directive 93/42/EEC (MDD), the Active Implantable Medical Device Directive 90/385/EEC (AIMDD),... 

In 2012, a European harmonized version of this standard was adopted by European Committee for Standardization as EN ISO 14971 2012. This version is harmonized with respect to the three European directives associated with MDs Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC. This was done to address the presumed compliance with the three directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard. 

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. 

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. 

European Council (1990) Directive 90/385/EEC of 20 June 1990 on active implantable medical devices. 

EMEA (2001) Guidelines relating to the application of the council directive 90/385/EEC on active implantable medical devices the council directive 93/42/EEC on medical devices, MEDDEV 2.1/3 rev 2 (July 2001). 

For the purpose of improving safety and efficacy, there are three Specific Product Safety Directives for active implantable medical devices, for other medical devices, and for in-vitro diagnostic medical devices. There is also a General Product Safety Directive, intended for "all medical devices that are supplied in the course of a commercial activity for use by consumers" to which none of the three Specific Product Safety Directives can be applied. 

European Parliament (2007) Medical devices directives Directive 2007/47/EC of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market... 

By way of evidence in snpport of this statement we would offer a EU commissioned report (IPTS 2000) which looked at the impact of the current Medical Device Directive on innovation with eHealth products (active implantable devices). The report stated, although many firms have taken time to adapt to the new system of accreditation, there is still the view that the new system is overly bureaucratic and therefore time and money consuming . 

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. 

---