EU IVDR Requirements

I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis.

General Background

The In Vitro Diagnostic Regulation (IVDR) is a regulation of the European Union (EU) that sets out the rules for manufacturers of in vitro diagnostic medical devices (IVDs) to follow in order to place their products on the EU market.

More stringent regulations as per public safety and patient safety for IVD products, before being placed in market for human use. 

This documentation includes:

In terms of:

The 157-page regulation entered into force on May 25th 2017, replacing the EU’s directive on In Vitro Diagnostic Medical Devices (98/79/EC) in order to regulate the use, distribution, and handling of medical devices that provide information about human samples (for example blood and tissues) which can lead to possible concisions about physiological and pathological processes. The scope of IVD devices covered under the regulation is significantly expanded and many devices have been reclassified.

This documentation includes:

Transition arrangements may apply to certain manufacturers in accordance with Article 110 of EU IVDR:

Support & Training

Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.

Key considerations for manufacturers under the EU IVDR include:

Overall, compliance with the EU IVDR requires significant resources and expertise from manufacturers. It is important for manufacturers to start the compliance process early and to work closely with their notified body and other stakeholders to ensure a smooth transition to the new regulation.

Our Services


AKRA TEAM can provide manufacturers with the necessary training package for the organization´s specific EU IVDR competency needs.
Manufacturers can request trainings and workshops in selected topics and/or general EU IVDR training.

Process and Templates Development

Contact AKRA TEAM to provide the necessary EU IVDR compliant templates and/or finalized documentation. AKRA TEAM provides the right experts to create and maintain parts of your technical documentation such as the PERs and SSPs, as well as QMS documentation such as SOPs for Post Market Surveillance, Vigilance and Reporting, Complaint Handling, Risk Management and more, which are necessary for an EU IVDR compliant QMS.

Gap Assessment

AKRA TEAM provides services to evaluate and assess quality, completeness, and conformity of the relevant documents. Documentation will be compared against EU IVDR requirements or feedback from the notified bodies to ensure conformity of the product(s). A detailed gap assessment will be presented to the customer.


AKRA TEAM provides hands on implementation support. The Team´s consultation and guidance ranges from providing strategic regulatory guidance and explanation of pathways their consequences to onsite and/or virtual intensive and daily collaboration with the manufacturer´s relevant employees to achieve preset goals.

Continuous update of documentation

Once EU IVDR compliant documentation has been implemented and submitted to the Notified Body, it may require continuous update due to requirements such as for PMS or due to any other changes triggered by the regulators, the market, the data on the device or by the manufacturer itself. AKRA TEAM will ensure follow-up and can accompany manufacturers to maintain compliance.

Interested in our services?

Lorem ipsum dolor sit amet, consec tetur adipis cing elit. Ut elit tellus, luctus nec ullam corper mattis, pulvinar dapibus leo.

Scroll to Top
GDPR Cookie Consent with Real Cookie Banner