Medical Tests Under EU 2017/746 Numbered IVDR (In-Vitro Medical Devices Regulation)

In the regulation (EU) 2017/746 on in vitro diagnostic medical devices published by the European Parliament and the Council, the rules regarding the placing of in-vitro diagnostic medical devices for human use and their accessories on the market or into service in the European Union countries are explained. This regulation also applies to performance studies conducted in European Union countries for such in-vitro diagnostic medical devices and accessories.

This regulation also repeals the directive 98/79/EC and the Commission decision no 2010/227/EU.

The following are not covered by this Regulation:

• Products for general laboratory use or for research purposes only (unless such products, by their properties, are intended for use by their manufacturers specifically for in vitro diagnostic examination)
• Invasive sampling products applied directly to the human body to obtain a sample
• International certified reference materials
• Materials used for external quality assessment programs

Significant impacts of in-vitro medical devices regulation include greater transparency, expanded coverage, increased surveillance, higher traceability, stricter requirements and analytical performance and scientific validity.

In short, a device under IVDR EU 2017/746 can only be put on the market or put into service if it complies with this legal regulation if it is duly procured and properly installed, maintained and used in accordance with its intended use. Such a device must meet the general safety and performance requirements set out in the said regulatory annex.

IVDR classification also takes into account the public health risk. In general, the IVDR classification includes the following four risk classes based on both patient and community health risks:

• Class A: Low patient and public health risk
• Class B: Moderate patient risk or low community health risk
• Class C: High patient risk or moderate public health risk
• Class D: High patient risk and high public health risk

Our organization, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, also provides medical testing services within the scope of EU 2017/746 IVDR (in-vitro medical devices regulation) with its trained and expert staff and advanced technological equipment.