In vitro diagnostic device

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In-vitro diagnostics ( IVD ) is a term for medical devices for medical laboratory testing of samples taken from the human body. These are examined (“diagnosed”, from ancient Greek διάγνωσις diágnosis , German 'distinction' , 'decision', from διά- diá- , German ' through- ' and γνώσις gnósis , German ) outside the body ( Latin in vitro , 'in the glass' ) 'Knowledge' , 'Judgment').


A comprehensive definition reads: In-vitro diagnostic device (IVD) is any medical device that is used as a reagent , reagent product, calibration material , control material, kit, instrument, apparatus, device or system - individually or in combination - according to the intended purpose specified by the manufacturer In vitro testing of samples obtained from the human body, including donated blood and tissue, is used and is used solely or primarily 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 are considered to be in vitro diagnostics. Sample containers are evacuated as well as other medical products that are specially manufactured by the manufacturer to receive samples from the human body immediately after they have been taken and to store them for in vitro diagnosis.

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. The manufacturer is responsible for determining the intended purpose and thus for deciding whether a product is an in vitro diagnostic device.

Legal regulations

Directive 98/79 / EC

The placing on the market of in-vitro diagnostics was regulated within the European Union by the so-called IVD directive 98/79 / EC (also called IVDD - In vitro diagnostic directive ), which in Germany and Austria by the national medical device law , in Switzerland is implemented by the Therapeutic Products Act. This directive does not apply to so-called in-house products (Article 1 (5) of Directive 98/79 / EC), but corresponding regulations from national laws do.

With the exception of products for performance evaluation, special, IVD from in-house production as well as products for the clinical trial must all in vitro diagnostic medical devices in their marketing with a CE mark be provided.

The assessment of in-vitro diagnostics according to Annex II of Directive 98/79 / EC (e.g. HIV tests) as well as in-vitro diagnostics for personal use must be carried out with the participation of notified bodies . All other in vitro diagnostics can be provided with the CE mark and brought onto the market at the manufacturer's own responsibility . The manufacturer alone is responsible for compliance with all legal requirements, reports the product to the competent authority, has the necessary technical documentation ready and provides the product with the CE mark .

Regulations for the placing on the market or the commissioning of the above Products such as B. Custom-made products or products made in-house can be found in Section 12 MPG.

For custom-made products, B. the conformity assessment procedure according to § 7 Abs. 5 MPV is prescribed. According to this, the manufacturer must issue a declaration in accordance with No. 2.1 of Annex VIII of Directive 93/42 / EEC (contains e.g. data for identifying the product as well as an assurance that the product complies with the basic requirements specified in Annex I of the directive) as well as the documentation according to No. 3.1 of Annex VIII of Directive 93/42 / EEC (description of design, manufacture, actual performance data of the product, etc.).

For the commissioning of IvD from in-house production, the (simplified) regulations according to Section 5 (6) MPV (if applicable) apply accordingly (Section 12 (1) sentence 3 MPG). This privilege does not apply to IvDs that are to be produced on an industrial scale for the purpose of medical analysis or diagnosis without being placed on the market. A CE marking can only be dispensed with if a laboratory produces IvD for exclusive use in its own facility and the in-vitro diagnostic device is not resold. However, this does not release the manufacturer from carrying out the conformity assessment procedure or from preparing the technical documentation for each product. For products in lists A and B of the IvD guideline, a notified body must also be involved for products from in-house manufacture.

New MDR / IVD regulation 2017

After several years of negotiations, the new EU regulation for in-vitro diagnostics officially entered into force on May 25, 2017. After a five-year transition period (until May 26, 2022), it will be mandatory for all manufacturers. As part of the new regulation, a new classification structure (assessment classes A – D) will be introduced, which is based on the intended use of the products. If the manufacturer specifies several purposes for a product and the product can therefore be assigned to more than one class, it is assigned to the highest of the classes. In general, the new regulation should lead to additional requirements for the approval of new and existing IVDs. This applies in particular to the significantly increased requirements in the context of technical documentation and clinical studies.


The development and approval of in vitro diagnostics is possible in around four to six years. Compared to drug development, this is about half the time. Investments of € 5 to 15 million are named. The tests with the final approval are nowhere near as time-consuming as those involved in drug development. For example, side effects and toxicity in in vitro methods based on the analysis of removed body fluids are not to be investigated.

See also

Web links

Individual evidence

  1. ^ Wilhelm Pape : Concise dictionary of the Greek language . Vol. 1: AK. 3rd edition. Vieweg & Sohn, Braunschweig 1914, p. 574 ( online at .).
  4. Epigenomics - on the move . ( Memento of the original from September 28, 2007 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Retrieved August 2, 2007. @1@ 2Template: Webachiv / IABot /