IVDR AWARENESS

As of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD).

As of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD).
April 6, 2021

As of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD). Implementing IVDR will be much easier with a good action plan in place. Asphalion can aid you to ease this transition with diverse services tailored to meet your needs.

With the new classification rules introduced by the IVDR, it is quite likely that your device is classified as a Class B, C or D device. If such is the case, you will soon need to contact a Notified Body (NB) in order to obtain a CE certificate for your device, as you will no longer be allowed to place it on the market without the assessment of a NB. However, if your device has a valid certificate under the IVDD, you can still place it on the market until May 2024. Nevertheless, the QMS and post-market surveillance activities as laid down in IVDR will have to be met by 2022, and you should consider that after May 2024 it will be necessary to have certified your device under IVDR.

Search News & Events

  • Filter by category

Share

Related news and events

Medical Device Regulation extended

Following informal contacts with the European Parliament, it is expected that the European
Parliament will vote on the text of the Commission proposal without amendments as its
position at first reading during the plenary session of 13-16 February 2023, through an
urgency procedure and subject to legal-linguistic revision of the text.

Publicación de la AEMPS de nuevas instrucciones para la realización de investigaciones clínicas con productos sanitarios en España

El real decreto sobre productos sanitarios en desarrollo, que sustituirá a los actuales reales decretos de productos sanitarios (Real Decreto 1591/2009) y de productos sanitarios implantables activos (Real Decreto 1616/2009), introduce modificaciones en la legislación nacional de productos sanitarios, con el objetivo de hacer posible la aplicación del Reglamento y desarrollar aquellos aspectos que el mismo deja al desarrollo de la legislación nacional.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting