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. 

Figure 9.1 Summary of key elements of the Essential Requirements from the medical device directives 90/385/EEC, 93/ 42/EEC and 98/79/EC.

The Commission provides a list of over 230 standards that may be used to establish conformance with the essential requirements of the medical device directives. 

The range of devices regulated under the general medical device directive, 93/42/EEC, can vary from the simple devices that pose little or no risk to patient or user health to those that are life-critical. It is neither economically feasible, nor justifiable in practice. 

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

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

London, 29th-30th Nov. 1999, paper 9 MEDICAL DEVICE DIRECTIVES, AS SUCCESSFUL AS EXPECTED ... 

The basic structure, concepts and terminology of the three Directives on AlMDs, MDs and 1 VDs are identical the differences that exist among them arise out of the different nature of these products. The following discussion will therefore focus on the medical devices directive (MDD), since this is the central Directive and covers most products. Short sections follow on AlMDs and IVDs. Detailed analysis of the relevant provisions would fill a large book what is intended here is to highlight the important aspects which should be considered. 

Other obligations apply to distributors of consumer products. The GPS obligations apply in the absence of other specific rules of Community law governing the safety of such products. It is clear that the obligations under the medical device Directives cover most, if not all, producers obligations which arise under the GPS Directive as set out above. Manufacturers are... 

From a classification point of view, ocular endotamponades are classical medical devices. Their application inside the human eye requires, besides ultra-purity, special controls during the manufacturing as well as for the release of finished products. They must be non-toxic and sterile and have to meet the general requirements of the European Medical Device Directive (MDD). 

In Europe, prior to the CE mark, medical devices were registered in individual countries, each having a set of specific registration requirements. In June 1993, the Council of European Communities issued the medical device directive (MDD), which has been transposed into national laws throughout the EC. The purpose of adoption of the MDD was to allow the health care industry to benefit from the advantages of a single European market and allow products to circulate freely in the EC without additional technical constraints issued by the various member states. 

Note Annex III, Section 3 of the Enropean Union s Medical Device Directive holds the key area that maps CE onto compnter validation requirements. 

The Medical Device Directive 93/42 defines medical devices and products, which combine a drug with a device. For regulatory purposes, the latter are subdivided and dealt with as follows ... 

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

The medical device and pharmaceutical industries have traditionally been separate businesses. The medical device industry generally develops products in line with the EC Medical Device Directive and the guidances issued by the CDRH office of the FDA, whilst the pharmaceutical industry looks to the relevant regulatory guidance available, including that from the FDA Center for Drug Evaluation and Research... 

An example of how the Medical Device Directive (MDD) and Medicinal Product Directive (MPD) are applied is outlined below for injection products [1,14] ... 

The precise definition of a medical device varies depending on the regulatory framework under consideration and even interpretation by individual countries. Examples include the European Commission s Medical Device Directive (MDD) and that of the US Food and Drug Administration. Whilst in principle each country can... 

At this point it is worth mentioning how the ALARP approach to risk acceptability changes markedly when it comes to medical devices. For example. International Standard ISO 14971 [10] affords manufacturers the ability to justify risks on an ALARP basis. The European Commission Medical Device Directive (MDD) [11] cites ISO 14971 as a Harmonised Standard however the directive contains a number of Essential Requirements on risk acceptability which appear to conflict with ISO 14971. 

Note that the international version of the standard and that used to achieve compliance with the EC Medical Device Directive vary slightly and in particular in the approach to risk acceptability aiteria (see Sect 3.3). 

A number of regulators including those enforcing the European Medical Device Directive now prefer manufacturers to demonstrate conformity through compliance... 

Many industries including nuclear engineering, aviation and the military have come to realise that human-system interaction can have a major impact on safety. In these domains regulatory processes have been put in place to mandate usability evaluation. Both the US FDA rules and Europe s Medical Device Directive require manufacturers to undertake usability studies (see Sect. 4.2.7). Even for products outside of medical device regulation, the contribution of usability issues to patient... 

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). 

The procedures for conformity assessment are chosen from the various modules and in accordance with the criteria set out in the primary directives. Departure from the procedures is allowed only when the specific circumstances of a directive so warrant. Quality is shown in some of the modules, but a common mistake for some ISO 9000 quality-certified companies is to assume that they can select a module that utilizes ISO 9000 when this is not possible unless the primary directive allows it. There is no mention of ISO 9000 quality in the LVD, EMC, and Machinery directives (see Product Quality versus Factory Quality in Chapter 5). ISO 9000 quality may be necessary for some products (i.e., medical products) under the Medical Device Directive (MDD). 

AIMD Active Implantable Medical Devices Directive... 

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