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EU In Vitro Diagnostic Medical Devices Regulation

In Vitro Diagnostics Medical Devices in the EU are regulated by the (IVDR) In vitro diagnostics Regulation which replaces the In vitro diagnostics medical device directive - 98/79/EC , coming into full application in May 2022. In Vitro Diagnostics Medical devices must comply with the MDR in order to obtain a CE marking certification and be sold on the EU market.

In Vitro Diagnostics Medical Device Regulation (IVDR)

  • Revised the laws governing IVD devices to ensure a robust, transparent, and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. The new regulation takes on a life-cycle approach to IVD device regulation.

  • Further involvement of Notified Bodies; with the new re-classification according to risk, it is estimated that at least 85% of IVD devices will need to undergo review by Notified Bodies instead of 15% of IVD devices under the IVDD.

  • For IVD devices to be certified, a Quality Management System (QMS) must be implemented. Many companies use the ISO13485 in their QMS implementation since it is the only QMS standard on the EU harmonized list.

  • In addition, a system for risk management must be established, documented, implemented, and maintained. The state-of-the-art standard for risk management systems is the EN ISO 14971.

  • The new regulation will also tighten requirements for clinical evidence and conformity assessment to strengthen pre-market approval of IVD devices. Clinical evidence for a device shall cover the elements of scientific validity, analytical performance, and clinical performance which demonstrates that the intended clinical benefit or benefits and safety will be achieved according to the state of the art in medicine and in conformity with the general safety and performance requirements.

  • Manufacturers of the IVD device will have to draw up and keep up to date technical documentations of the IVD device. All technical documents shall cover each part of a product’s lifecycle, including:

    • Design, manufacture, installation, preparation for use, verification before use, usage, maintenance, calibration, elimination, and post-market surveillance (PMS) plan.

    • Manufacturers must also have systems in place to cover their financial responsibility for harm caused by defective devices.

  • To improve the traceability of medical devices a unique device identification (UDI) shall also be implemented. This will enable more quick and efficient recall of IVD devices that has been discovered to have potential safety risks. In addition, information on devices and studies being made public such as on the European Database for Medical Devices (EUDAMED).

  • In the new life-cycle approach, there will be requirements relating to post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices.

Scope and definition of In Vitro Diagnostic Devices

  • ‘In vitro diagnostic medical device’ refers to any medical device which is a reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donation, derived from the human body, solely or principally for the purpose of providing information on one of more of the following:

    • Concerning a physiological or pathological process of state

    • Concerning congenital physical or mental impairments

    • Concerning the predisposition to a medical condition or disease

    • To determine the safety and compatibility with potential recipients

    • To predict treatment response or reactions

    • To define or monitor therapeutic measures

  • Companion diagnostics were included in the new scope of IVD devices, where it was not included previously under the IVDD.

In Vitro Diagnostics Medical Device risk classification

  • The new rule-based risk classification system is more flexible than the list-based system it replaces, allowing the IVDR to better keep pace with technological progress and the need to address emerging medical conditions.

  • The risk classification of a device is determined by its intended purpose and takes into consideration not only the risk to the individual but also the risk to public health.

  • The IVDR has laid out 7 rules to determine the risk classification of medical devices into the following 4 classes:

    • A: low individual risk and low public health risk

    • B: moderate individual risk and/or low public health risk

    • C: high individual risk and/or moderate public health risk

    • D: high individual risk and high public health risk.

  • Class A devices will be self-certified by their manufacturers unless they are sold as sterile. Devices in Classes B, C and D will require conformity assessment by a Notified Body.


[1] ec.europa


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