In vitro diagnostics (IVD)

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.

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:

b) Definition of the FDA

The FDA’s definition is similar:

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:

• Overview of the approval of IVDs (in vitro diagnostics)
• Classification of in vitro diagnostics
• Classification of IVD software
• 7 steps to a medical device
• Harmonized standards for the verification of general safety and performance requirements

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

• the intended purpose of the device,
• the development process,
• the risk management,
• the verification and validation,
• the performance evaluation of IVDs, which may require sample size planning and the anonymization and pseudonymization of personal data,
• usability, including instructions for use, and other labeling,
• electrical safety and electromagnetic compatibility (as formulated in IEC 61010-2-101).

d) Further requirements

In addition, manufacturers must ensure that, for example

• they have implemented a quality management system in accordance with ISO 13485,
• have a responsible person (PRRC),
• assign a Unique Device Identification (UDI) for their devices,
• register themselves and their devices in the EUDAMED,
• validate their production processes,
• carry out the necessary post-market surveillance activities and implement vigilance processes.

3. Particular requirements for specific IVDs

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

• Devices for self-testing and near-patient tests
• Companion Diagnostics (CDx)
• In-house IVD (formerly Laboratory Developed Tests, LDTs)
• Sampling kits

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

• Software as medical device
• Qualification and classification of IVD software
• IVD software manufacturers take note
• Regulatory requirements for medical devices with machine learning
• Parameterization of software
• Decision support systems as medical devices