In vitro diagnostic medical devices or in vitro diagnostics (IVDs) are a subgroup of medical devices. IVDs obtain medical information from human samples. Their clinical benefit lies in providing precise, accurate, and correct information to support or to make a diagnosis.

Content

This page gives you a quick overview of the regulatory requirements for in vitro diagnostics:

  1. Definition of an in vitro diagnostic medical device
  2. Regulatory requirements for IVDs
  3. Particular requirements for specific IVDs
  4. Support for IVD manufacturers and laboratories

1. Definition IVD

a) Definition in Europe

The EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) defines what an in vitro diagnostic medical device is:

Definition: In vitro diagnostic medical device

means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

  • concerning a physiological or pathological process or state;
  • concerning congenital physical or mental impairments;
  • concerning the predisposition to a medical condition or a disease;
  • to determine the safety and compatibility with potential recipients;
  • to predict treatment response or reactions;
  • to define or monitoring therapeutic measures.

specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

Source: IVDR, Article 2

b) Definition of the FDA

The FDA’s definition is similar:

Definition:  In vitro diagnostic product

In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

Source: 21 CFR 809.3 (a)

2. Regulatory requirements for IVDs

a) Regulatory frameworks

In Europe, manufacturers, importers, and distributors of in vitro diagnostics must comply with the IVDR. You should be aware of the differences between the IVDR and IVDD.

Depending on the product type, other EU regulations, common specifications, or EU directives (e.g., the Machinery Directive) may be relevant for an IVD.

The FDA has its requirements for placing IVDs on the market.

b) Approval

The following articles provide the necessary expert knowledge for the approval of in vitro diagnostics:

c) Requirements to be verified

To be allowed to place IVDs on the market in Europe and other markets, these devices must meet requirements. These include the General Safety and Performance Requirements set out in Annex I of the IVDR, as well as requirements relating to

d) Further requirements

In addition, manufacturers must ensure that, for example

3. Particular requirements for specific IVDs

Specific IVDs must meet particular requirements. These articles provide an overview:

If the devices contain software or qualify as IVD software, the following articles are helpful:

4. Support for IVD manufacturers and medical laboratories

a) Free support offers

Do you still have questions about in vitro diagnostics and the regulatory requirements? You can get answers in our free micro-consulting.

Download the free starter kit, which will give you an overview of the regulatory landscape and show you the steps to get your IVD “approved.” It also contains the IVDR checklist in PDF and DOCX format!

b) Videos and e-learning

The video training courses at the Medical Device University show you how to create your technical documentation and your QM system lean, fast, and IVDR-compliant. Over 100 templates and sample documents are available for you to download.

This will enable you to create the prerequisites for approving your devices quickly and safely and launching them on the market.

c) Seminars

Some of our seminars are aimed specifically at IVD manufacturers and laboratories.

d) Product tests

The experts at the Johner Institute will help you test your devices:

e) Consulting and support

The Johner Institute experts will help you develop your devices in compliance with regulatory requirements and bring them to market. We can either assist you or take on some of the work.

Benefit from the regulatory affairs experts to help you

Contact us now to clarify together how you can quickly and efficiently meet the regulatory requirements of the IVDR and get your devices safely to the market.

Contact us


Harmonized standards: Evidence for medical device manufacturers

Most manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…

Details

Approval of IVDs (in vitro diagnostic medical devices) in the EU

In vitro diagnostic medical devices (IVDs) are medical devices used to analyze samples derived from the human body. Typically, these products are reagents, kits, instruments, and devices. Software can also be considered as an IVD regarding its intended purpose. When “approving IVDs,” manufacturers must comply with many regulations, laws, and standards. 1. Significant steps for…

Details

Classification of in-vitro diagnostic medical devices: how to avoid a too-high classification

The classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To ensure that your IVD product is not unnecessarily allocated to a high-risk class, this article provides an overview of 1. What qualifies a product as an IVD?…

Details

General laboratory equipment: What manufacturers and laboratories need to know to avoid problems and unnecessary expense

One assumption persists: General laboratory equipment such as PCR cyclers, NGS devices, fragment analyzers, centrifuges, pipetting robots, and extraction kits must bear a CE-IVD marking. Is this correct? There is often a lack of clarity about Hence, there are uncertainties, in order not to make themselves liable to prosecution. This article provides clarity and gives…

Details

Regulation (EU) 2017/746: In vitro Diagnostic Medical Device Regulation (IVDR) – February 2024

The European In Vitro Diagnostic Medical Device Regulation (IVDR) must be followed by manufacturers who wish to place in vitro diagnostic medical devices on the market in the EU. The Regulation (EU) 2017/746 In vitro Diagnostic Medical Device Regulation (IVDR) regulates the entire life cycle of in vitro diagnostic medical devices (IVDs) in the European market. The IVDR came…

Details

Transitional provisions of the IVDR

In December 2021, the EU extended the transitional periods of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) (Regulation 2022/112). In March 2023, the European Commission decided to abolish the “sell-off period” for IVDs that comply with Directive 98/79/EC (IVDD) (Regulation 2023/607). In January 2024, the European Commission published a proposal to amend the IVDR, which further extends…

Details

Laboratory products for “Research Use Only” (RUO) – often a dangerous claim

Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge…

Details