MDCG update and the latest MDCG 2020-16 Rev.5

MDCG Guidance for Medical Device Software: Class I, Class A and the Latest IVDR Update

Which guidance documents should software manufacturers follow and what does the new revision of MDCG 2020-16 Rev.5 actually change?

For manufacturers of medical device software (MDSW), regulatory guidance extends beyond software qualification and classification. Clinical or performance evidence, cybersecurity, software updates, distribution and post-market activities also deserve attention.

MDR Class I and IVDR Class A manufacturers should maintain a relevant selection of MDCG guidance rather than follow only documents specifically labelled “software”. Post-market surveillance, for example, remains relevant to both classes.

A practical MDCG reference set

The following documents provide a useful starting point. They are not all new and their relevance depends on the software’s intended purpose, functionality and regulatory status. Each linked title leads to an official source.

MDCG 2019-11 Rev.1 Qualification and Classification of Software under MDR and IVDR

The starting point for determining whether software is regulated and how its classification is established.

MDCG 2020-1 Clinical Evaluation / Performance Evaluation of Medical Device Software

Guidance on clinical evaluation under MDR and performance evaluation under IVDR for MDSW.

MDCG 2019-16 Rev.1 Guidance on Cybersecurity for Medical Devices

Cybersecurity considerations throughout development and the device lifecycle.

MDCG 2023-4 Medical Device Software–Hardware Combinations

Relevant when software depends on sensors or other data-collection hardware to achieve its medical purpose.

MDCG 2025-4 Safe Making Available of MDSW Apps on Online Platforms

Responsibilities and product information when distributing medical software through app platforms.

MDCG 2025-6 FAQ on the Interplay between MDR, IVDR and the AI Act

An additional reference where software incorporates AI. Read alongside the applicable legislation.

MDCG 2021-24 Rev.1 Guidance on Classification of Medical Devices

The broader MDR classification framework, complementing the software-specific guidance.

MDCG 2019-15 Rev.1 Guidance Notes for Manufacturers of Class I Medical Devices

An overview of manufacturer obligations for MDR Class I devices.

MDCG 2024-11 Guidance on Qualification of In Vitro Diagnostic Medical Devices

Helps establish whether a product falls within IVDR before assigning its class.

MDCG 2020-16 Rev.5 Guidance on Classification Rules for IVDs

IVDR classification, including instruments, software and devices used in combination

MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and IVDs

PMS planning, information gathering and reporting, including MDR Class I and IVDR Class A devices.

MDCG 2023-3 Rev.2 Questions and Answers on Vigilance Terms and Concepts

Incident assessment, reporting and corrective-action concepts under MDR and IVDR.

MDCG 2018-5 UDI Assignment to Medical Device Software

Software-specific identification and assessment of whether changes require new UDI identifiers.

What changed in MDCG 2020-16 Rev.5?

On 9 September 2026, the Commission published MDCG 2020-16 Rev.5, Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

The revision history identifies a clarification of the Rule 7 rationale and examples. It does not introduce a new Class A rule or amend the IVDR.

Under the existing Rule 7, controls lacking an assigned quantitative or qualitative value are classified as Class B. Controls with assigned values fall under implementing rule 1.6 and follow the classification of the device concerned.

The updated guidance explains that indicative analyte ranges supplied with standalone laboratory quality-control materials are not necessarily “assigned values” when the laboratory determines its own target values. These materials cannot replace the controls required to verify the IVD’s performance.

Source: MDCG 2020-16 Rev.5, see Rule 7

Why should Class A and software manufacturers care?

The wider guidance remains useful for checking how an instrument, its software, reagents and controls are classified. Devices used together do not necessarily share the same classification. The IVDR requires separate assessment, subject to specific implementing rules linking certain products to the device they support.

Class A is not the default for IVD software

Under IVDR implementing rule 1.4, software driving or influencing a device follows that device’s class. Independent software is classified in its own right. Rule 6 assigns Class B to devices not covered by the preceding classification rules: “no higher-risk rule applies” does not automatically mean Class A.

MDCG 2019-11 Rev.1 illustrates the distinction. Software exclusively operating a Class A analyser can follow its classification. Software with its own diagnostic purpose requires assessment of that purpose and the applicable rules, even when installed on an analyser. Physical installation is not the deciding factor.

The instrument’s function matters

The blood-gas-analyser example in MDCG 2020-16 distinguishes Class A instruments using replaceable sensor cassettes or reagents from instruments measuring the specimen directly. In that example, direct-measurement configurations fall into Class B or C depending on the consequences of erroneous results. These are illustrative classifications, not a blanket rule for every analyser.

Sources:
MDCG 2019-11 Rev.1, Software classification MDR and IVDR
IVDR, See Annex VIII classification and implementing rules

And what about MDR Class I software?

MDR Class I and IVDR Class A are separate classifications under different regulations.

For MDR software, MDCG 2019-11 Rev.1 remains the main software-specific reference. Rule 11 retains a Class I category for software outside its diagnostic, therapeutic-decision and physiological-monitoring provisions, but all other applicable rules must also be considered. Class I is a conclusion to justify, not a starting assumption.

The latest IVDR guidance does not change MDR software classification.

Source: MDCG 2019-11 Rev.1, Software classification MDR and IVDR

What should manufacturers do now?

My recommendation is to include relevant MDCG guidance in the company’s controlled Regulatory Requirements Register, while distinguishing guidance from binding legislation.

For each device or device family, document the intended purpose, regulatory qualification, applicable classification rules and resulting rationale. Where software, instruments, reagents and controls interact, make their respective functions and classification relationships explicit.

Review new guidance for actual impact rather than merely replacing an old reference number. Where the assessment concludes that no changes are needed, record the reasoning.

For this update, the practical question is not “Have we downloaded Revision 5?” It is:
Does our documented classification still match what our device, software and associated products actually do?

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