Medical Device Directive 93/42/EEC
The scope of 98/79/EC applies to IVD medical devices and accessories, which can include not just reagents and kits but also instruments and software. Article 1 of 98/79/EC gives the legal definitions which confirm that IVDs are a specific category of medical devices with particular differences and are therefore controlled under this separate Directive. The definitions mentioned in the In vitro diagnostics Medical Device Directive is stated as follow:
“Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.”
This directive 98/79/EC has to apply to the whole spectrum of IVDs, it does not define specific technical factors but instead identifies broad based essential safety requirements to be met by all devices.
The risk and intended use and properties associated with a device determines the classification, and therefore the level of control and review that’s necessary. The In Vitro Medical Device Directive groups devices into four categories.
- Other/General Device:
all devices except those mentioned in Annex II and self-testing devices;
Annex II is a chapter in the Directive and is sub-divided into two lists, List A and List B. All Annex II IVD’s require the involvement of a Notified Body before the product can be placed on the market
- Device for Self-Testing (not listed in Annex II):
a device intended by the manufacturer to be able to be used by a person in a home environment, excluding self-test devices covered in Annex II;
- Device of List B, Annex II:
This category includes reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self-testing for blood sugar;
- Device of List A, Annex II
The last category includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.
All IVD’s should have technical documentation in order provide the supporting evidence that the product complies with the Essential Requirements out of the IVD Directive 98/79/EC. An important aspect of this documentation will be the performance evaluation of the device, which demonstrates that the performance meets the claims and intended use specified by the manufacturer.
Conformity assessment routes and the role of the Notified Body
The IVD Directive 98/79/EC indicates different routes for manufacturers to comply with the requirements indicated in the IVD Directive 98/79/EC and applicable standards. The different conformity routes, as described in the New Approach Directive, are dependent on the classification of the device and therefore are linked to the perceived risk of that product.
For higher risk devices (mentioned in List A, List B and devices for Self-Testing) the manufacturer must gain independent certification by a Notified Body in order to complete the conformity route process, apply for CE Marking and be able to place the device on the European market.
For the very highest risk devices in List A, there are additional requirements to address this high risk. Each List A device must undergo a detailed review of the technical documentation called the EC Design Examination.
Example of List A Devices are reagent and reagent products, including calibrators and control materials for:
Determining blood groups
• Rhesus (C, c, D, E, e)
• Anti Kell “
The detection, confirmation and quantification of
• HIV 1 and 2
• HTLV I and II
• Hepatitis B, C and D
The non-EU manufacturer must appoint an official Authorized Representative which must be established in the European Union member states and is appointed by the manufacturer to act on manufacturer’s behalf in carrying out any tasks relating to the certified product.
As described in the CE marking Directives, the appointed Authorised Representative established in the European Union must be able to act on behalf of the manufacturer. The delegation of tasks from the manufacturer to the Authorized Representative must be explicit and should take place in writing, in particular to define and to refrain the contents of the tasks and the limits of the representative.
Labelling and CE Marking
A section mentioned in the Essential Requirements give a detailed explanation of the content and type of information that has to be provided to the user. The labelling includes both the labels and Instructions for Use of the device. This includes clearly identifying the legal manufacturer and the intended use of the IVD device.
There are national language requirements for labelling, which are mandatory for self-test IVDs where the user has to have instructions in their own language and the language where the IVD devise is put into use.
Post Market Surveillance
While Notified Bodies are involved in the pre-market approval process, the Competent Authorities (CA) concentrate on post market surveillance. Manufacturers are required to set up an ongoing systematic process to review experience gained for their device on the market and to have a vigilance procedure in order to immediately inform relevant competent authorities of incidents involving their device.
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