Directive 98/79 / EC
 Directive 98/79 / EC |
|
|---|---|
| Title: | Directive 98/79 / EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices |
| Designation: (not official) |
IVD guideline |
| Scope: | EEA |
| Basis: | EC Treaty , in particular Article 100a |
| Procedure overview: |
European Commission European Parliament IPEX Wiki |
|
To be implemented in national law by: |
December 7, 1999 |
| Implemented by: | Medical Devices Act (Germany) |
| Replaced by: | Regulation (EU) 2017/746 |
| Expiry: | May 26, 2022 |
| Reference: | OJ L 331 of 7.12.1998, pp. 1-37 |
| Full text |
Consolidated version (not official) basic version |
| The regulation must have been implemented in national law. | |
| Please note the information on the current version of legal acts of the European Union ! | |
Council Directive 98/79 / EC of October 27, 1998 on in vitro diagnostic medical devices is an EC directive and is referred to as the IVD directive for short in Germany and Austria. Internationally, the directive is referred to as the In-Vitro Diagnostic Directive (IVDD) or Directive 98/79 / EC.
It is the essential regulatory instrument for the performance of in vitro diagnostics in the European Economic Area .
It was repealed by Regulation (EU) 2017/746 of April 5, 2017.
Definitions
In vitro diagnostic device
As in-vitro diagnostic device as defined in Directive each "medical device" holds, the a reagent , reagent, calibrators, control material, kit, instrument, apparatus, device or system - alone or in conjunction with each other - after the specified by the manufacturer Intended In -vitro testing of samples obtained from the human body, including blood and tissue donations, is used and is used solely or mainly to provide information:
- about physiological or pathological conditions or
- about congenital abnormalities or
- to check the safety and compatibility of the potential recipients or
- to monitor therapeutic measures.
Sample containers
Sample containers are considered to be in vitro diagnostics. Sample containers are evacuated as well as other medical products that are specially manufactured by their manufacturer to receive samples from the human body immediately after they have been taken and to store them for in vitro diagnosis.
Laboratory equipment
Products for general laboratory use are not regarded as in-vitro diagnostics, unless, due to their characteristics, they are to be used specifically for in-vitro tests in accordance with the intended purpose specified by the manufacturer.
equipment
An accessory (for an in-vitro diagnostic device) is any item that is not itself an in-vitro diagnostic device, but is to be used together with a product according to the purpose specified by its manufacturer so that it can be used in accordance with its intended purpose .
For the purposes of this definition, invasive products intended for taking samples as well as products which come into direct contact with the human body for the purpose of sampling are not considered accessories for in-vitro diagnostics in the sense of Directive 93/42 / EEC.
Calibration and control material
For the purposes of this guideline, calibration and control material is any substance, any material and any object that is intended by its manufacturer to compare measurement data or to check the performance characteristics of a product with regard to the application for which it is intended.
Product for personal use
A "product for personal use" is any product that can be used by laypeople in the home environment according to the intended purpose specified by the manufacturer. Accordingly, the primary group of users of in-vitro diagnostics is to be assigned to the relevant specialist personnel.
Product for performance evaluation purposes
A “product for performance evaluation purposes” is a product that is intended by the manufacturer to undergo one or more performance evaluation tests in laboratories for medical analysis or in some other appropriate environment outside of its own premises.
Legal implementation
Like all European directives , the primary aim of the directive is to enable the free exchange of goods. This can be seen from Article 2, which requires: "The Member States shall take all necessary measures to ensure that the products may only be placed on the market and / or put into operation if they meet the requirements if they are properly delivered, installed, maintained and used for the intended purpose of this Directive. This includes the obligation of Member States to monitor the safety and quality of these products. This article also applies to products that are provided for performance evaluation purposes. "
The other articles deal with the administrative implementation and refer to further legal links.
The IVD guideline is implemented in national law through corresponding national laws, in Germany and Austria through the Medical Devices Act (law on medical devices), even if in vitro diagnostics are by definition not medical devices. The Switzerland refers Remedies Act also (HMG) to this Directive.
Classification of in vitro diagnostics
A number of risk products are explicitly listed in Annex II of the directive, for which a special conformity assessment procedure is required. Accordingly, in-vitro diagnostics are divided into the following classes:
- List A according to Annex II
- List B according to Annex II
- Products for personal use
- General in vitro diagnostics
The classification is based on the principle of exclusion. The general class therefore includes all IVDs that are neither included in List A nor in List B and are not intended for personal use by laypeople.
List A
List A includes the following reagents and reagent products, including the corresponding calibration and control materials, in accordance with Annex II of the Directive:
- for the determination of the following blood groups : AB0 system , rhesus (C, c, D, E, e), Kell system .
- for the detection, confirmation and quantitative determination of markers of HIV infections (HIV 1 and 2), HTLV-I and II as well as hepatitis B, C and D in samples of human origin.
List B
According to Annex II of the Directive, List B includes the following reagents and reagent products, including the corresponding calibration and control materials for the following purposes:
- Determination of the following blood groups: Duffy system , Kidd system .
- Determination of irregular anti-erythrocyte antibodies .
- Detection and quantitative determination of rubella or toxoplasmosis .
- Evidence of hereditary disease: phenylketonuria .
- Detection of the following infections in humans: cytomegalovirus , chlamydia .
- Determination of the following HLA tissue types : DR, A, B.
- Detection of the tumor marker PSA .
- Specific estimation of the risk of Down syndrome (including software for calculation).
- Products for personal use for blood sugar determination .
Products for personal use
Products for personal use are intended for use by laypeople in the home environment (with the exception of products for measuring blood sugar, these are to be assigned to List B). Typical products in this class are:
General class
All other in vitro diagnostic medical devices are to be assigned to the general class. The manufacturer can carry out the conformity assessment for these products on his own responsibility without the obligatory involvement of a notified body .
Web links
Individual evidence
- ↑ Regulation (EU) 2017/746. Retrieved February 27, 2020 .
