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EU-Richtlinie (IVD)

neoLab - IVD-Verordnung

 EU regulation concerning  zu IN-VITRO DIAGNOSTICS

In-vitro diagnostics (IVD) have been regulated by the European guideline 98/79/EG (IVDD) since the year 1998. The new IVD regulation was published on 05.05.2017 and replaces the previous IVDD since 26.05.2017. neoLab Migge GmbH will present to you the most important changes below.

 


What are in-vitro diagnostics?

In-vitro diagnostics are medical products, typically laboratory devices, that are intended by the manufacturer for special diagnostics of samples from the human body. 

What must be considered?

The aim of the new IVDR is to revise the previous IVDD. The IVDR is considered a regulatory basis for the market intro-
duction of in-vitro diagnostics (IVD) and their accessories. 

Which deadlines are in place?

A transitional period for approved in-vitro diagnostics is in place until May 26th, 2022. Manufacturers may request an extension of this deadline by 2 years.

What are IVD products

In-vitro diagnostics are medical products that serve for in-vitro analysis of samples stemming from the human body. This includes i.e. blood, tissue, saliva and urine samples. IVD enables information concerning:

  • + physiological or pathogenic processes or conditions
  • + congenital bodily or mental impairments
  • + predisposition for a specific health condition or a specific disease
  • + to determine the harmlessness and tolerability for potential recipients
  • + the expected effect of a treatment or the predicted reactions
  • + the determination or supervision of therapeutic measures Sample containers are considered IVD.

IVDR and the most important changes

The aim of the new IVDR is to remedy the weaknesses of the previous IVDD (98/79/EG) which have arisen over time. The IVDR thereby acts as regulatory basis for bringing in-vitro diagnostics (IVD) into circulation, their introduction to the market, and their implementation. The EU regulation is legally binding in all EU- and EFTA member states since 26.05.2017.

An overview over the most important changes to the IVDR:

Expansion of the product scope
The previous scope according to IVDD has been expanded significantly. Genetic testing, IVD for diagnostic purposes and other tests supplying information regarding a specific disease of the patient or the effect of a treatment are considered IVD. Among other things products with a high risk, which are produced and used within a single healthcare facility are considered IVD.

Risk-based classification system
The IVDR requires clinical studies regarding performance and proof, that the safety of the products is appropriate. Additionally the manufacturers of a continuous assessment of the potential safety risks must collect and store clinical data.


Requirements for clinical assessments
The IVDR requires clinical studies regarding performance and proof, that the safety of the products is appropriate. Additionally the manufacturers of a continuous assessment of the potential safety risks must collect and store clinical data.

 

Requirements for documentation
The technical documentation is listed in a clear, organized, easily searchable clear manner. These concern themselves with product descriptions, specifications, including the variants and accessories, and the technical documentation of the supervision upon bringing the IVD into circulation.

 

Monitoring through designated entities
With the exception of IVD class A involvement of designated entities is required. The verification of the IVD according to IVDD previously amounted to approx. 15% of all IVD distributed on the market. With the IVDR taking effect the involvement of designated entities is increased to at least 70%. Additionally stricter requirements are introduced for the naming and supervision of the designated entities.

 

Allocation of unique product numbers
By means of a system for product recognition through unique product numbers (UDI-System – Unique Device Identification system) the traceability of products after bringing them into circulation shall be increased notably. This leads to improved reporting in case of incidents, focused safety correction measures and better supervision through the responsible entities.


Designation of a  “qualified person“
Through the designation of at least one “qualified Person“ the compliance to the regulations and requirements for the manufacturers of medical products shall be guaranteed. The organization must prove, that the person is appropriately qualified for the demanded tasks.

No grandfathering of approved IVD
The IVD distributed on the market and certified by IVDD do not receive grandfathering and require a certification according to IVDR. A legal transitional period up to 26.05.2022 was defined, in which the certification must be successful.

 


Transitional periods for manufacturers

A transitional period until May 26th, 2022 is in place for already approved in-vitro diagnostics (IVD) in order to adapt products to the new requirements of the IVDR. Products from manufacturers, which have already been certified by a designated entity (present and valid certificate according to IVDD as well as no major product changes), may be marketed for another 2 years before proving this certification according to IVDR.


Additional information concerning the EU guideline (IVD)

The new EU regulation concerning in-vitro diagnostics @TÜV-Süd - Here for the overview.pdf >>

Official MDR-Webseit of the EU - Link >>

ebsite: TÜV SÜD - What should I keep in mind concerning the topic IVD? - Link >>