There are three EU directives for the safety of medical devices: the Medical Devices Directive, 93/42/EEC; the Active Implantable Medical Devices Directive, 90/385/EEC; and the In Vitro Diagnostics Medical Devices Directive, 98/79/EC. Their approach is different in that they cover different aspects of medical device use and therefore design.
The Medical Devices Directive, 93/42/EEC and its amendments, covers the majority of medical devices on the market. They are divided on the basis of risk into 3 main classes and a number of sub-classes. Class I devices are the lowest risk and, unless they are supplied sterilised or have a measuring function, are declared to be compliant by the manufacturer using the manufacturer͛s self-declaration route. Products which fall into the definition of Class II and III in the directive have higher risks associated with them and therefore the support of a Notified Body for the CE marking of the products is generally required.
Compliance with the requirements of the Active Implantable Medical Devices Directive, 90/385/EEC and its amendments may be achieved by following one of two routes: either the EC Declaration of Conformity, or the EC Type-Examination routes. In the case of the former the manufacturer must have a quality system that has been assessed and certified by an approved Notified Body. In the case of the latter route a Notified Body observes and certifies that a representative sample of the product envisaged satisfies the relevant provisions of the Directive.
The In Vitro Diagnostic Medical Devices Directive, 98/79/EC is intended to control the design and use of all types of products used in the analysis of human body samples. Compliance with the directive is by either manufacturer͛s self-certification or the intervention of an approved Notified Body. As with the other medical device directives the latter route is only used for high risk devices or products.
Eurolink (Europe)͛s Role: Eurolink (Europe) can provide consulting and practical services to help clients to meet the demands of the Medical Devices directives, including:
- Advising clients on the applicability of the various Medical Devices directives, including:
- Distinguishing between the three main classes of the Medical Devices Directive.
- Providing guidance on the appropriate routes to compliance under the Active Implantable Medical Devices Directive and In Vitro Diagnostics Directive (self declaration or use of a notified body)
- Advising clients with Class I medical devices on the steps to be taken in order to achieve self-certification
- Examining and approving clients͛ documentation to ensure that it meets the requirements of the regulations
- Registering Class I medical devices on behalf of clients
- Registering IVD products on behalf of clients
- Providing guidance on the requirements of planned changes to the directives
- Providing general Authorised Representative services