In Vitro Diagnostic Medical Devices
(IVD MD)

Since December 7, 2003, in vitro diagnostic medical devices (IVD medical devices) have been regulated under Directive 98/79/EC for access to the European market. However, Regulation (EU) 2017/746, also known as the IVDR, introduced major changes for manufacturers, distributors, and other stakeholders in the IVD market. The IVDR became mandatory on May 26, 2022. As a result, manufacturers must now meet stricter requirements for IVD medical device certification, conformity assessment, compliance, and market placement in the European Union.

Regulatory changes for IVD medical devices

The regulatory changes for in vitro diagnostic medical devices (IVDMDs) have a major impact on manufacturers. In addition, they create new obligations for economic operators, IVDR notified bodies, Member States, and the European Commission.

These changes are set out in Regulation (EU) 2017/746. The Regulation was published in 2017 and became mandatory on May 26, 2022, for placing in vitro diagnostic medical devices on the European Union market.

The recent IVDR extension 2024/1860 also affects the transition timeline for certain devices. As a result, manufacturers must follow the current IVDR requirements carefully.

Impact on manufacturers

Nearly 80% of IVDMD manufacturers will need an IVDR notified body for IVDR certification and CE marking. This is a major increase compared with the previous directive for in vitro diagnostics.

Therefore, manufacturers and economic operators must understand the certification process. They must also know their regulatory obligations and the role of IVDR training.

Wider definition under the IVDR

One of the most important changes is the wider definition of in vitro diagnostic medical devices under Article 2 of Regulation (EU) 2017/746.

The definition now includes:

– software devices
– predisposition to a medical condition or disease
– prediction of treatment response

Definition under Article 2

An in vitro diagnostic medical device is any medical device, such as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system. It may be used alone or in combination.

The manufacturer intends it for in vitro examination of specimens from the human body, including blood and tissue donations. It must provide information about one or more of the following:

– a physiological or pathological process or state
– congenital physical or mental impairments
– predisposition to a medical condition or disease
– safety and compatibility with potential recipients
– prediction of treatment response or reactions
– definition or monitoring of therapeutic measures

The Regulation also covers:

– specimen receptacles
– accessories
– self-testing devices
– devices used for services offered to lay persons
– near-patient testing devices
– companion diagnostics

New manufacturer obligations

The IVDR introduces several new obligations for manufacturers. For example, under the IVDR extension 2024/1860, manufacturers must appoint a person responsible for regulatory compliance.

In addition, the Regulation introduces joint liability for the Authorized Representative in the event of defective devices. It also sets out more detailed responsibilities for distributors and importers.

Risk-based classification

The IVDR uses a risk-based classification system. It is based on the seven rules in Annex VIII. The Regulation defines four classes of IVDMDs, from Class A to Class D.

Class A = low risk
Class D = high risk

A notified body is required for:

Class D devices
Class C devices
Class B devices
sterile Class A devices
self-testing devices
near-patient testing devices
companion diagnostics

Examples of classification

Class D: HIV screening for blood donations
Class C: HLA typing, blood sugar self-testing
Class B: antinuclear antibodies, pregnancy self-testing
Class A: specimen receptacles

Clinical evidence and performance evaluation

Manufacturers must document clinical evidence in a performance evaluation report for IVDR certification. This report must include:

– scientific validity
– analytical performance
– clinical performance

This evaluation helps show that the device meets the required standards. It also supports the overall evidence needed for compliance.

Ongoing compliance

The IVDR also requires continuous performance evaluation. This process helps ensure ongoing safety and performance.

Manufacturers must regularly reassess clinical evidence. They must use data from:

– post-market surveillance
– post-market performance follow-up (PMPF)

Therefore, regular review is essential. Manufacturers must also keep up with IVDR training, regulatory requirements, and certification obligations.

GMED is a leading notified body that supports medical device manufacturers worldwide with regulatory certification, CE marking, and quality management system assessments. Our multidisciplinary team helps manufacturers meet the latest regulatory requirements. We also provide expertise for all device categories, including innovative products and high-risk medical devices.

Backed by the LNE Group, GMED offers integrated certification and testing services throughout the product lifecycle, from design to market placement. In addition, we actively follow regulatory developments and standardization work. This helps ensure that your devices meet current safety and performance requirements.

Learn more about GMED’s certification process and capabilities.