In Vitro Medical Device Regulation enters into application

26/05/2022 News Europe , Policy 155 Views
In Vitro Medical Device Regulation enters into application

As of today (May 26), new rules on in vitro diagnostic medical devices (IVDR) such as HIV tests, pregnancy tests or COVID-19 tests, will be applicable in the EU. The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in medical science. By aligning market access requirements in the different EU Member States, it also safeguards fair market access for manufacturers.

Medical devices, including in vitro medical devices, have a fundamental role in saving lives by providing healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease.

In summary, the Regulation on in vitro diagnostic medical devices introduces three important advances:

  • Improves the quality, safety and reliability of in vitro diagnostic medical devices with a new risk-based device classification system, more detailed and stringent rules on the evaluation of device performance, and greater involvement of independent conformity assessment bodies (‘notified bodies’). New scientific bodies such as a panel of experts and EU reference laboratories can be involved in the assessment of the highest-risk devices.
  • Strengthens transparency and information for patients, so that vital information is easier to find. The European database of medical devices (Eudamed) will contain information about all in vitro diagnostic medical devices on the market, including economic operators and certificates issued by notified bodies. A unique device identifier will be mandatory for every product so that it can be found in Eudamed. For medium- and high-risk devices a summary of safety and performance will be made publicly available.
  • Enhances vigilance and market surveillance:Once devices are available on the market, manufacturers have to collect data about their performance and EU countries will closely coordinate their vigilance and market surveillance activities. 

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