A Guide to IVDR Regulations

Regulation (EU) 2017/746 IVDR (In Vitro Diagnostic Regulation) is a European Union regulation that governs the use of in vitro diagnostic (IVD) medical devices, which are tools used to test samples like blood or tissue. Regulation (EU) 2017/746 was implemented on 26th May 2022.

The IVDR sets consistent standards for safety and quality for medical devices used in in vitro diagnostics across all countries where the regulation is enforced. In this article, we’ll explore IVDR regulations in more depth, including the background of IVDR and why it’s important.

Background of IVDR 

Medical devices play a crucial role in saving lives by offering healthcare solutions for diagnosing, preventing, monitoring, predicting, and treating diseases, as well as improving patient outcomes.

The IVDR  (EU) 2017/746 sets a regulatory framework for in vitro diagnostic devices, like HIV tests, pregnancy tests, and SARS-CoV-2 tests. In 2021, approximately 70% of clinical decisions were relying on these types of diagnostic tools.

Why Was IVDR Introduced?

The IVDR was established to enforce greater transparency in the manufacturing process of medical devices and diagnostic assays, ensuring higher standards of safety and reliability. All devices must be reviewed by a notified authority responsible for ensuring product quality and compliance with regulatory standards.

What are the Changes from IVDD?

IVDR replaced an older rule, Directive 98/79/EC (IVDD), which also covered IVDs. This regulation was introduced in April 2017, and is similar to the EU regulation on medical devices. However, there were also some changes.

Key changes from the IVDD to the IVDR include a revised device classification system, stricter oversight of manufacturers by Notified Bodies, the introduction of a "Person Responsible for Regulatory Compliance" (PRRC), mandatory UDI (Unique Device Identification) marking, the establishment of common specifications, Eudamed database registration, and enhanced post-market surveillance activities.

IVDR Classifications

One of the changes that have been made is the introduction of a risk-based classification system with four classes:

• Class A - low individual and public risk

• Class B - moderate individual risk and low public risk

• Class C - high individual risk and moderate public risk

• Class D - high individual risk and high public risk 

Only devices in the lowest risk category, Class A, are exempt from the requirement of oversight by a Notified Body under the IVDR.

Economic Operator Roles

If you are a manufacturer, authorised representative, importer, or distributor of IVDs in the EU, or a regulatory affairs or quality management professional working with IVDs, it is essential to understand how to ensure compliance. We outline the roles below:

Manufacturers

The manufacturer plays a key role in ensuring compliance with the EU MDR. Since both the device and the manufacturer must adhere to these regulations, the manufacturer bears the majority of the obligations that need to be fulfilled.

Authorised Representative

An authorised representative is any individual or legal entity based in the European Union who has received and agreed to a written authorisation from a manufacturer located outside the EU. This representative acts on the manufacturer’s behalf in carrying out specific tasks related to the manufacturer’s obligations under the Regulations (which describe the responsibilities of authorised representatives, and outline the tasks that a manufacturer can delegate to the authorised representative, along with the conditions that must be met for this delegation to occur). 

Importers

An importer is defined as any person established in the EU who places a device from a third country onto the EU market. The importer is responsible for ensuring that the devices they place on the market carry the CE marking, are labelled according to the Regulation, include all required information, and have a Unique Device Identifier (UDI) assigned, where applicable. MDR/IVDR Article 13 describes many of the general obligations of importers.

Distributors

A distributor is any individual or entity in the supply chain (apart from the manufacturer or importer) that makes a device available on the market up to the point of putting it into service.

Distributors must ensure, through representative sampling, that the devices they distribute comply with the obligations outlined in MDR/IVDR Article 14.

Guidance from the Medical Device Coordination Group

The Medical Device Coordination Group (MDCG) publishes guidance to provide clarity and support regarding IVDR. The members of the MDCG are experts appointed by the EU member states. Some examples of the topics covered include:

• Covid-19
• Borderline and classification
• Custom made devices
• New technologies including software as a medical device
• Notified bodies

EQA and IVDR

Within the IVDR regulation, Chapter 1, Section 1, Article 1 ‘Subject matter and scope’, point 3(d) states that the regulation does not apply to materials used for external quality testing schemes.

Their statement confirms that EQA materials are not required to meet IVDR regulations. Therefore, no action is needed from UK NEQAS or any of our EU participants regarding the continued provision and participation in UK NEQAS EQA schemes under the IVDR regulation.

EQA at UK NEQAS IIA

At UK NEQAS IIA, we provide external quality assessment services to laboratories globally, helping support accuracy and reliability. In addition to quality testing, we offer a variety of educational resources in our Digital Academy such as webinars, publications, and more to help laboratories stay informed and excel in their practices.