• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Español
  • English
  • Bloglovin
  • Email
  • Facebook
  • Instagram
  • LinkedIn
  • Twitter
  • YouTube
CDE Almería – Centro de Documentación Europea – Universidad de Almería

CDE Almería - Centro de Documentación Europea - Universidad de Almería

Centro de Documentación Europea de la Universidad de Almería

  • HOME
  • WHAT´S ON
    • EU BULLETINS
    • EU NEWS
    • Activities
    • EU Calls and Awards
    • Radio Program «Europe with You»
  • DOCUMENTATION
    • Bibliographic Collection
      • Almería EDC Digital Collection
      • UNIVERSITY OF ALMERIA LIBRARY
    • Documentation by topic
    • EU Media Collection
      • Web Space
      • MEDIATHEQUE REPOSITORY
  • Europe on the net
    • Institutions
    • EU Representation in Spain
    • European information network of Andalusia
    • EU official journal
  • ABOUT US
    • Presentation
    • People
    • Contact

Stronger rules for placing medical tests on the market

Inicio » EU News » Health » Diseases » Stronger rules for placing medical tests on the market

2022-05-30

As of tomorrow, new rules on in vitro diagnostic medical devices (IVDR) such as HIV tests, pregnancy tests or COVID-19 tests, will be applicable. 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.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “Diagnostic medical devices are key for lifesaving and innovative healthcare solutions. Today we are marking a big step forward for the patients and the diagnostics industry in the EU. The COVID-19 pandemic has underlined the importance of accurate and safe diagnostics, and having stronger rules in place is a key element in ensuring this is the case for EU patients.” 

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. 

Background

The Regulation on in vitro diagnostic medical devices replaces an earlier Directive and significantly reinforces the regulatory framework for medical tests. It is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices.

In January 2022, the European Parliament and the Council amended the transitional provisions of the Regulation on in vitro diagnostic medical devices for those devices already on the market. The amendment allows for a progressive roll-out of the Regulation with the length of the transition periods depending on the risk class of the device. However, the date of application of the Regulation on in vitro diagnostic medical devices remained unchanged.

The Regulation on in vitro diagnostic medical devices is complemented by the Regulation on medical devices, which has been applicable since 26 May 2021.   Examples of medical devices are contact lenses, x-ray machines, ventilators, pacemakers, software, breast implants, hip replacements and sticking plasters.

New agreement to recognise COVID-19 as an occupational disease

Source: European Commission 

Publicaciones relacionadas:

European Commission authorises first safe and effective vaccine against COVID-19 Indonesia is connected to the EU Digital COVID Certificate system Covid-19: EU recovery plan should prioritise climate investment Time to accelerate the transition to a low-carbon economy, says European civil society Commission lists key steps for effective vaccination strategies and vaccines deployment

“This is a space for debate. All comments, for or against publication, that are respectful and do not contain expressions that are discriminatory, defamatory or contrary to current legislation will be published”.

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Primary Sidebar

Publicaciones relacionadas

European Commission authorises first safe and effective vaccine against COVID-19 Indonesia is connected to the EU Digital COVID Certificate system Covid-19: EU recovery plan should prioritise climate investment Time to accelerate the transition to a low-carbon economy, says European civil society Commission lists key steps for effective vaccination strategies and vaccines deployment

Footer

Logotipo en negativo del Centro de Documentación Europea de Almería

CDE Almería
Edificio Parque Científico-Tecnológico (Pita)
Planta: 1ª, Despacho: 29
04120. Ctra. Sacramento s/n. Almería (Spain)
Teléfono: (+34) 950 015266

HOME
NEWS
DOCUMENTATION
EUROPE ON THE NET
ABOUT US

LEGAL NOTICE
PRIVACY POLICY
COOKIE POLICY
ACCESSIBILITY

SITEMAP
HELP CENTER

Copyright © 2022 CDE Almería · Creative Commons LicenseThis work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

<p>El Centro de Documentación Europea de la Universidad de Almería utiliza cookies propias y de terceros para facilitar al usuario la navegación en su página Web y el acceso a los distintos contenidos alojados en la misma. Asimismo, se utilizan cookies analíticas de terceros para medir la interacción de los usuarios con el sitio Web. Pinche el siguiente enlace si desea información sobre el uso de cookies y como deshabilitarlas. ajustes</p>

Politica de privacidad

El Centro de Documentación Europea de la Universidad de Almería utiliza cookies propias y de terceros para facilitar al usuario la navegación en su página Web y el acceso a los distintos contenidos alojados en la misma. Asimismo, se utilizan cookies analíticas de terceros para medir la interacción de los usuarios con el sitio Web. Pinche el siguiente enlace si desea información sobre el uso de cookies y como deshabilitarlas. <a href="/politica-de-cookies" rel="noopener" target="_blank">Más información</a>

Cookies estrictamente necesarias

Las cookies estrictamente necesarias tiene que activarse siempre para que podamos guardar tus preferencias de ajustes de cookies.

Básicamente la web no funcionara bien si no las activas.

Estas cookies son:

  • Comprobación de inicio de sesión.
  • Cookies de seguridad.
  • Aceptación/rechazo previo de cookies.

Si desactivas esta cookie no podremos guardar tus preferencias. Esto significa que cada vez que visites esta web tendrás que activar o desactivar las cookies de nuevo.

Cookies de terceros

Esta web utiliza Google Analytics, Google Tag Manager y Yandex Metrika para recopilar información anónima tal como el número de visitantes del sitio, o las páginas más populares.

Dejar estas cookies activas nos permite mejorar nuestra web.

¡Por favor, activa primero las cookies estrictamente necesarias para que podamos guardar tus preferencias!

Política de cookies

Pinche el siguiente enlace si desea información sobre el uso de cookies y como deshabilitarlas. Más información