In Vitro Diagnostic Regulation (IVDR)—Frequently Asked Questions

The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a new regulation that will create a robust, transparent, and sustainable regulatory framework that “improves clinical safety and creates fair market access for manufacturers and healthcare professionals”(1).

The IVDR “brings EU legislation into line with technical advances, changes in medical science, and progress in law-making”(1). IVDR has binding legal enforcement throughout all EU member states, and it sets higher standards for quality and safety of IVD devices.

The majority of our current CE-marked IVDs will transition to the IVDR.

The timeline is progressive (2) and depends on a product’s classification.

The new rules contain a number of changes, including the introduction of a risk-based classification system with four risk classes of in vitro diagnostic medical devices:

• Class A (low individual risk and low public health risk)
  • Class A devices will be self-certified by their manufacturers unless they are sold as sterile
• Class B (moderate individual risk and/or low public health risk)
• Class C (high individual risk and/or moderate public health risk)
• Class D (high individual risk and high public health risk)

Instruments such as the QuantStudio 5 Dx and QuantStudio 7 Pro Dx real-time PCR systems are classified as Class A non-sterile

Reagents such as the MagMA Viral/Pathogen II Nucleic Acid Isolation Kit and the SpeciMAX Dx Stabilized Saliva Collection Kit are classified as Class A sterile

COVID-19 assays: TaqPath COVID-19 assays are in Class D (Clinical Testing Solutions: Your Questions, Answered)

Non–COVID-19 assays: the majority are Class C and Class B

Devices in Classes B, C, and D will require conformity assessment by a Notified Body.

OEMpowered blog post: IVDD vs. IVDR: Classifications defined and compared

For questions related to specific products, please contact our team today.

Customers producing LDTs have additional considerations. By including in-house assays in the scope of the IVDR, the aim of the EU Health Authorities is not only to restrict the use of in-house assays, but to equal the compliance between commercial tests and in-house assays.

In many cases, laboratories may need to transition from in-house assay use to CE-IVD-marked device use, due to Article 5 (3).

In circumstances where patient needs cannot be met by available commercial tests, in-house assays/LDTs may still benefit from an exemption to the full IVDR, by applying Article 5 only.

Some additional constraints and considerations include:

• The devices must not be transferred to another legal entity
• Appropriate quality management systems such as standard EN ISO 15189 or applicable national provisions
• Product may not be made on an industrial scale
• Justification by documenting why an equivalent device available on the market is not used

In-house assays may be more difficult to validate and to justify use, but will remain important for some healthcare institutions and rare conditions.

Yes. The institution making an in-house assay (also defined as laboratory-developed test or LDT) must demonstrate and document its safety and performance.

This compliance requirement is generally welcomed as it may improve the quality of in-house products in line with CE-IVD products.

Competent authorities will verify compliance. Enforcement strategies between EU countries may vary.

In 2022, the EU will begin to enforce the transition from the current In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) for clinical diagnostic applications. 

On May 26, 2022, the IVDR becomes effective, meaning after that date any new IVD devices placed on the market must be CE marked according to IVDR.

A recent amendment by the commission to the implementation of the IVDR allows some existing products (excluding Class A non-sterile devices) to continue to be placed on the market in compliance with the IVDD. The length of the extension is dependent on risk class.

The new progressive transitional timeline for implementation of the IVDR Article 5.5 is:

• Compliance with the GSPRs in Annex I
• No transfer of devices between legal entities
• No manufacture on an industrial scale
• Competent authority oversight

• Appropriate QMS system: ISO 15189 "Medical Laboratories – Requirements for Quality and Compliance" and manufacturing process
• Review experience gained from clinical use

• Justification for use over commercially available tests

The considerations are very different depending on if there is or is not an equivalent IVDR-compliant device on the market.

Our IVDR transition team is here to help you with scenario planning specific to your needs. Contact our team today.

Laboratories complying with ISO 15189:2012 may find that they largely comply with Annex I of the IVDR.

Laboratories with no existing accreditation may find that compliance requires greater effort.

Our IVDR transition team is here to help you with scenario planning specific to your needs. Contact our team today.

Note: Manufacturing process is not covered by ISO 15189 but required under Annex I.

Putting together an assay from raw materials and components; making a new device from used CE IVDs; modifying a CE IVD to deviate from IFU; making a device from RUO reagents or instruments.

General Safety & Performance Requirements

Means an organization of which the primary purpose is the care or treatment of patients or the promotion of public health. It’s established in the EU. Includes private laboratories that support the healthcare system, even if they do not treat or care for patients directly.

In-house assays/in-house devices, also referred to as “homebrew assays” or “LDTs” (laboratory-developed tests)

In vitro diagnostics; regulated product with a restricted in-house assay; homebrew assays intended use and protocol for use labelled with “for in vitro diagnostic use”; and IVD accessories

Instructions for use; part of CE IVD products

Research use only; non-regulated product; no set intended use; protocol for use open for adaptation/change; labelled with “for research use only not for diagnostic use”