In vitro diagnostics
In vitro diagnostic (IVD ) is a term for medical products for medical laboratory testing of samples originating from the body. These are outside the body (in vitro is Latin for ' in glass ') examined ( diagnosed Greek διάγνωσις, Diagnosis ' distinction, decision ' from διά, diá, ' by - ' and γνώσις, gnosis, ' knowledge, judgment ').
Definition
A comprehensive definition is: In vitro diagnostic ( IVD) is any medical device which is a reagent, reagent product, calibrators, control material, kit, instrument, apparatus, equipment or system - individually or in combination - to after the laid down by the manufacturer to be is in vitro investigation of originating from the body specimens, including blood and tissue donations, 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.
Specimen receptacles are considered to be in vitro diagnostic medical devices. Specimen receptacles `are those devices that are manufactured by its manufacturer specially designed to collect derived from the human body samples immediately after collection and kept in the purpose of in vitro diagnostic use.
Products for general laboratory use are not in vitro diagnostic medical devices unless they are to be used because of their characteristics according to their specified by the manufacturer to be specifically for in vitro studies. The responsibility for their intended purpose and thus for deciding whether a product is an in vitro diagnostic use, incurred by the manufacturer.
Legal regulations
The marketing of in vitro diagnostic medical devices within the European Union through the so-called IVD Directive 98/79/EC ( IVDD also - in vitro diagnostic directive called ) regulated, which in Germany and Austria by the National Medical Device Act, Switzerland is implemented by the Therapeutic Products Act. For so -called in- house products, this Directive but appropriate rules of national law does not apply (Article 1, Section 5 of Directive 98/79/EC ), very well.
With the exception of products for performance evaluation, special, IvD from in-house production as well as products for the clinical trial all in vitro diagnostic medical devices should be provided in their marketing with a CE mark.
Regulations on the marketing and commissioning of the above-mentioned products, such as custom or products from in-house production can be found in § 12 MPG.
For custom- eg is the conformity assessment procedure pursuant to § 7 para 5 MPV prescribed. After that, the manufacturer must draw up a declaration pursuant to Section 2.1 of Annex VIII of Directive 93/42/EEC ( for example, includes data identifying the product as well as an assurance that the product meets the requirements set out in Annex I to Directive Essential Requirements ) and according to point 3.1 of Annex VIII of Directive 93/42/EEC to create the documentation ( description of design, manufacture, actual performances of the product, etc.).
In - house production found for the commissioning of IVD from the ( simplified ) according to regulations. § 5 § 6 MPV (as applicable ) shall apply ( § 12 paragraph 1 sentence 3 MPG). This privilege does not apply to IVD (or generally products ) that are to be produced and used in professional and commercial context for the purpose of medical analysis and diagnosis without being placed on the market. Only if a laboratory IVD manufactures for the exclusive use in their own facility and no resale of the products or results produced using the IVD itself prepared are (eg the dissemination of research results of a routine laboratory to a private practitioner ), can to a CE marking shall be waived. This does not relieve the manufacturer of not carrying out the conformity assessment procedure or by the creation of technical documentation for each product. For devices in List A and B of the IVD Directive notified body must also be integrated with products from in-house production.
Admission
The development and approval of in vitro diagnostic medical devices is possible in about four to six years. Compared to drug development, this is about half the time. This amounts to € 5 to 15 million are mentioned as investments. The tests with the final approval are not nearly as expensive as in drug development or in vivo diagnostics. For example, side effects and toxicity in vitro methods that are based on the analysis of sampled body fluids, not to analyze.