Date 05.09.2026
Author Helena Lacalle
Category EU MDR, IVDR, Switzerland
Reading Time: 20 minutes

Labelling of medical devices and IVDs under the EU MDR and IVDR

Labelling is a complex and frequently underestimated component of medical device and IVD design. Whereas the EU MDR and IVDR govern the format and content requirements for labelling of CE-marked devices, there is more to consider. Without compliant labelling, a device is unduly placed on the market.
This blog article brings together the different labelling requirements that manufacturers should be aware of.

Key takeaways

  • “Labelling” for medical devices and IVDs tends to be broadly interpreted. The requirements may affect not only device direct labelling, packaging labels, and instructions for use, but also implant cards, SSCP/SSP, and marketing materials.
  • Procedure Packs and Systems, demo units, and software graphic user interface (GUI) are subject to labelling considerations beyond what is listed in Chapter III, Annex I of the EU MDR/IVDR.
  • The Instructions for Use may be provided in electronic form (e-IFU) only under strict conditions. The manufacturer must establish specific processes to ensure e-IFU compliance.
  • Labelling language requirements are governed at the national level, not under the EU MDR/IVDR. Manufacturers need to become familiar with the language requirements in each country where they wish to market their devices.

Content

What information is affected by EU MDR/IVDR labelling requirements? And what is labelling, in fact?

The term “labelling” should be avoided for regulatory purposes, as it is confusing.

“Labelling” is used multiple times throughout the EU MDR and IVDR and mostly refers to packaging labels. However, there is no legal definition of “labelling”. The guidance documents issued by the Medical Device Coordination Group (MDCG) refer to “labelling” sometimes as synonym of labels only, and sometimes as synonym of labels and instructions for use (IFU). 

The new version of ISO 18113-1 relative to IVD labelling refers to the definition of “labelling” in EN ISO 13485:2016, which is equivalent to “information supplied by the manufacturer” and includes: labels and instructions for use (IFU), plus any information on device identification, intended purpose, technical description or proper use. This concept matches the recommendation of the International Medical Device Regulatory Forum (IMDRF) in its principles of labelling, IMDRF GRRP-WG/N52.

Indeed, “information supplied” with the device by the manufacturer is a better term than “labelling”. It corresponds to what is required per Chapter III of the General Safety and Performance Requirements (GSPRs), i.e. Annex I of the EU MDR and IVDR. It covers the information necessary to identify the device and its manufacturer as well as any safety and performance information to be provided by the manufacturer on the:

  • device itself (i.e. direct labelling, including on-software labelling), 
  • packaging labels, 
  • Instructions for Use (IFU), regardless of the medium (i.e. paper or electronic form),
  • manufacturer’s website.

And yet, this list is not even complete.

Device manufacturers cannot ignore the labelling language requirements of each individual country in which they wish to market their devices.

Additional documents concerned as “information supplied” by the manufacturer are:

Implant Cards

Per EU MDR Article 18, manufacturers of implantable devices must supply an implant card together with the implanted device, with certain exceptions (i.e. sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors). In addition, the manufacturer must provide instructions in the IFU for the healthcare professional who must fill out the implant card.

EU MDR Article 18(1) indicates that the information provided in the implant card shall be stated in the language(s) determined by the concerned Member State. Guidance document MDCG 2019-8 recommends the use of recognized symbols to avoid national versions, i.e. translations. Yet, there is no symbol for “device type”, and this information on the implant card needs to be provided in the required national languages. A non-exhaustive list of terminology for “device type” in English is available from guidance document MDCG 2021-11. The manufacturer is responsible for their correct translation.

Summary of Safety & Clinical Performance (SSCP) / Summary of Safety & Performance (SSP)

The Summary of Safety and Clinical Performance (SSCP) required per EU MDR Article 32 for all implantable and Class III devices, and the Summary of Safety and Performance (SSP) required per IVDR Article 29 for all Class C and D IVDs, are also viewed as “labelling”. They convey essential information about the device to the end user or the patient. Thus, SSCP and SSP must be written in a way that is understandable for the intended reader.

For the SSCP, translations are justified in guidance document MDCG 2019-9, by analogy to the IFU requirements. As such, the SSCP content intended for patients should be provided in all the languages required for IFUs intended for laypersons in the Member States concerned. If the required languages do not include English, an English translation must also be provided because it is the most common language in scientific publications and widely understood by healthcare professionals. MDCG 2019-9 further requires that one SSCP document be created per language, and that the language validated by the Notified Body be indicated. By analogy, the same requirement applies to the SSP.

What about marketing materials?

Marketing or promotional materials are not mentioned in the EU MDR or IVDR as part of the information to be supplied by the manufacturer. In principle, language requirements in the national legislation adopting the EU MDR and IVDR do not apply to them. 

More explicitly, standard EN ISO 20417, on the information to be supplied by the manufacturer of medical devices, excludes promotional materials (called marketing information) from its scope but indicates that some jurisdictions may consider such supplemental information as information supplied by the manufacturer, which is the case, for example, in the USA. This exclusion from scope is carried over word by word from the IMDRF’s Principles of Labelling for Medical Devices.

«Marketing or promotional materials are not mentioned in the EU MDR or IVDR as part of the information to be supplied by the manufacturer.»

Even if marketing materials are not explicitly considered to be “information supplied by the manufacturer” under the EU MDR and IVDR, they might be covered by specific, national legislation of EEA countries and Turkey implementing the EU MDR and IVDR. Manufacturers should seek local guidance from their distributors on any specific restrictions or conditions for promotional materials, including those presented in their websites.

How to understand “labelling” for medical device software?

Software not being a physical product, the concepts of label and IFU need special interpretation. Unfortunately, there is not much information in the EU MDR/IVDR regarding the labelling of medical device software. And there are no MDCG guidance documents on how to label software, either. 

The software’s graphic user interface (GUI) is usually considered a component of the device instead of labelling. Consequently, the manufacturer must ensure that the GUI complies with the applicable GSPRs, in particular those regarding risks related to use errors. This requirement for the safe and correct use of medical device software can be fulfilled by different means: symbol-based GUI, fully or partially translated GUI, or clearly explaining the English GUI in the IFU made available in the local language. The manufacturer should justify the chosen solution and document it in the risk management file. For standalone software (incl. mobile apps), it is essential to distinctly separate the IFU from the actual software functions, since the information supplied by the manufacturer tends to be provided in contextual menus, on multiple GUI sections.

For standalone software (incl. mobile apps), it is essential to distinctly separate the IFU from the actual software functions.

Only Part C of Annex VI, relative to the Unique Device Identifier (UDI), explicitly refers to software labelling for the purpose of affixing the UDI. According to the requirements for UDI carriers, the software “about” menu or start-up screen is viewed as the label of software. A similar view had been expressed by the British competent authority, MHRA, in an old guidance document about medical device software. It is therefore recommended that manufacturers compile all the information required on a device label (e.g. device name, intended purpose, manufacturer’s particulars, EU Authorized Representative) on the “about” menu or start-up screen, bearing in mind that:

  • For modular software, all required label elements will need to appear on each software module.
  • Each different platform version (iOS and Android), and each GUI language is a software variant that needs its UDI-PI and its “label”.
  • Placeholders would need to be allocated in the “about” menus or start-up screen for label contents that might still be undetermined at the time of software compilation (e.g. EU Authorized Representative).

What labelling requirements apply to Procedure Packs and Systems?

Under the EU MDR, Procedure Packs are combination of products packaged together and intended for a specific medical purpose [EU MDR Art. 2(10)], whereas Systems are combination of products, either packaged together or not, intended to be interconnected or combined to achieve a specific medical purpose [EU MDR Art. 2(11)].

The requirements for Procedure Packs and Systems are governed under EU MDR Art. 22 but this article only sets out high-level labelling details, namely:

  • Procedure Packs and Systems shall not bear an additional CE marking.
  • They shall bear the name & address of the “producer“, i.e. the entity assembling the Procedure Pack or System.  
  • Procedure Packs and Systems shall be accompanied by the information required in GSPRs # 23 of EU MDR Annex I.

In addition, per EU MDR Annex VI, Part C, point 3.7, Procedure Packs and Systems shall bear their own UDI.

The above information is largely insufficient to assist assemblers of Procedure Packs and Systems in generating compliant labelling. EU MDR Art. 22 does not even indicate that, when the Procedure Pack or System is sterilized, the related information should appear on the Procedure Pack or System label. And the only MDCG guidance documents that cover Procedure Packs or Systems are limited to Unique Device Identifier (UDI) aspects.

In Switzerland, Swissmedic has published an Information Sheet on Systems and Procedure Packs, which still falls short of helping with labelling questions.

Tips from Decomplix’ own experience

  • The EU MDR indicates that Procedure Pack or System shall be “accompanied” by the information to be provided by the manufacturer for the individual devices therein. Yet, this does not mean that an IFU should be generated for the Procedure Pack or System. It means that the individual devices contained in the Procedure Pack or System should keep the original packaging and labelling, as provided by their manufacturers. Failure to do so would correspond to repackaging or relabelling, subject to EU MDR Art. 16 requirements, unless such repackaging/relabelling is undertaken under the control of the corresponding manufacturer.
  • The outer labels of Procedure Packs or Systems should not include any CE mark (for example, when referring to the status of the devices contained) or other recognized symbols that can only be affixed by the manufacturer of the individual devices contained in the Procedure Pack or System.
  • The outer label must include the name and contact details of the assembler, the UDI-PI of the Procedure Pack or System, and a lot or serial number. Where applicable, the expiry date and/or storage conditions of the Procedure Pack or System shall be indicated and shall correspond to the most restrictive ones of the contents.
  • For Procedure Packs or Systems that are sterilized by the assembler, the sterile status, sterilization method, use-by date and storage conditions, as well as identification Notified Body involved in the conformity assessment must also be indicated on the outer label.

Now, the labelling requirements for Systems that are not packaged together are not addressed anywhere, and assemblers should apply common sense to ensure that the necessary information is duly conveyed throughout the distribution chain.

What about demo units?

Demonstration (demo) units are devices intended for temporary display without actual clinical use on patients.

Under the EU MDR/IVDR, this concept applies to devices that cannot be “made available on the market” either because they are not yet CE-marked or because they are not fully compliant with the MDR requirements. Demo units can be shown at trade fairs, exhibitions, demonstrations or similar events, provided they are labelled with a visible sign indicating that they are intended “for demonstration purposes only” or similar wording. Demo units shall not bear a (misleading) CE-marking. [EU MDR Art. 21(3) or IVDR Art. 19]

The use of demo units is typically limited in time. Manufacturers should establish a mechanism to ensure that such demo units are not inadvertently placed on the market or used for clinical purposes.

What requirements apply to the IFU under the EU MDR and IVDR?

In general, the medium, format, content, legibility, and location of the IFU must be appropriate to the device risk and type of user. Different approaches are possible, per chapter III of the General Safety and Performance Requirements (GSPRs) in Annex I of the EU MDR and IVDR.

Under the EU MDR and IVDR, the IFU should be provided together with the device, with the following exceptions:

  • For non-IVDs:
    • The IFU might not deemed necessary for the safe use of Class I and Class IIa devices only, if justified.
    • A single IFU may be provided when multiple units of same device are supplied to the same user/location.
    • Non-paper IFU (basically, electronic IFU or e-IFU) is allowed for professional use only and under the conditions in Reg. (EU) 2021/2226, which include a risk assessment of the electronic format and its availability by the user.
  • For IVDs:
    • If the IVD can be used safely and as intended without IFU, it can be waived or abbreviated.
    • A single IFU may be provided when multiple units of same IVD are supplied to the same user/location, but this is not possible for self-testing or near-patient testing.
    • Non-paper IFU (i.e. e-IFU) is allowed for professional use only and except for near-patient testing.

Following the GSPRs and international standards is not enough. There are multiple interconnections to consider.

The chosen approach for providing the IFU should be documented by the manufacturer both in the GSPR checklist under GSPR # 23.1(d) for the EU MDR or GSPR #20.1(d) for the IVDR, and in chapter 2 of the Technical Documentation for the concerned device.

The minimum IFU contents are governed by the following GSPRs: 

  • For non-IVDs: GSPR # 23.4 in EU MDR Annex I.
  • For IVDs: GSPR # 20.4.1 in IVDR Annex I, with additional requirements for self-test IVDs in GSPR # 20.4.2. Moreover, the requirements on Safety Data Sheet in Reg. (EC) 1907/2006 (REACH) need to be considered unless all relevant information is already present in the IFU.

Now, following the GSPRs and international standards is not enough. There are multiple interconnections to consider. Consistent interrelation with the following processes is essential:

  • Clinical evaluation: aligned intended purpose and indications (i.e. clinical evidence for claims).
  • Risk management: residual risks presented in the IFU as limitations, contra-indications, precautions or warnings.
  • Usability engineering: tested readability and understandability of the IFU for the intended user.

Last, additional and sometimes conflicting information might be required under other applicable legislation or standards. The most frequent cases to consider are:

  • Electrical safety information and symbols, per standard EN 60601-1.
  • Electromagnetic Compatibility (EMC) information, per standard EN 60601-1-2.
  • Disposal of electronic equipment, per Dir. 2012/19/EU (WEEE).
  • Safety Data Sheet for IVD substances, per Reg. (EC) 1907/2006 (REACH) and Reg. (EC) 1272/2008 (CLP).
  • CE-marking info per Dir. 2011/65/EU on restriction in hazardous substances in electronic/electrical equipment (RoHS).
  • CE marking info per Dir. 2014/53/EU on radio equipment (RED).
  • CE-marking info per Reg. (EU) 2016/425 on personal protective equipment (PPE).
  • CE-marking info per Reg. (EU) 2023/1230 on machinery.
  • Partially integrated in pharmaceutical labelling for combination products, per Title V of Directive 2001/83/EC on medicinal products.

What requirements apply to labels under the EU MDR and IVDR?

The minimum contents on the labels of medical devices and IVDs are governed by GSPRs, as follows:

  • For non-sterile devices: per EU MDR Annex I, chapter III, GSPR # 23.3 / IVDR Annex I, chapter III, GSPR # 20.3.
  • For sterile devices: per EU MDR Annex I, chapter III, GSPR # 23.2 / IVDR Annex I, chapter III, GSPR # 20.2. The picture below represents a typical label for a sterile medical device, where all information except the device name and intended purpose is presented in the form of internationally recognized symbols, typically according to EN ISO 15223-1.

Per EU MDR GSPR # 23.1 & IVDR GSPR # 20.1, the information expected to be present on the “label” should in fact be placed on the device itself. If this is not practicable or appropriate, it shall then be placed on the packaging of each unit or (if not possible) of multiple devices.

Labels must be provided in human-readable format and may be supplemented by machine-readable information, e.g. radio- frequency identification (RFID) or bar codes. 

Labelling for visually impaired users is not an explicit requirement (e.g. Braille-based or otherwise tactile labels) but might need to be considered as part of usability engineering.

The UDI carrier is an essential element of device traceability that must be affixed on the device or its label. Per EU MDR/IVDR Annex VI Part C:

  • Each device unit separately sold shall have its UDI.
    Exception: configurable devices, where the UDI is assigned at the configurable device level only.
  • The UDI carrier, both in Automated Identification for Data Capture (AIDC) and in Human-readable Interpretation (HRI) formats, must be affixed on the label and on all higher packaging levels. 
    Exceptions: 
    • shipping containers, exempted of UDI labelling; 
    • in case of limited label space, where the UDI carrier can be placed on the next packaging level; 
    • and AIDC format not being mandatory for retail point-of-sale packaging and standalone software.
  • The UDI carrier shall be directly affixed on the device itself for reusable devices.
    Special case: spectacles and contact lenses, given their limited size.

Manufacturers should be aware that labels are subject to translations just like IFUs. The use of internationally recognized symbols, mostly those in standard EN ISO 15223-1, instead of text where appropriate, prevents the need for translation.

What labelling languages should the manufacturer consider?

EU MDR Article 10(11) and IVDR Article 10(10) explicitly require the manufacturer to supply the information required in Chapter III of Annex I in the “official Union language(s) determined by the Member State in which the device is made available to the intended user or patient”. 
In other words, the EU MDR and IVDR do not provide any information about which languages are required for which “labelling” elements and what exceptions apply. 

Because the EU MDR and IVDR apply in the European Economic Area (EEA) and Turkey, manufacturers would need to seek the information in the national legislation of each country within the territory where they intend to sell the devices.

The table below shows the official national languages in the EEA and Turkey.

These would add up to 27 languages, in addition to English. However, not all of them are required for medical device labelling and/or exceptions are possible for professional use in some countries. 

In fact, by law, different situations are possible:

  • Local language is mandatory, without exceptions. 
  • Local language is required, but portions of the labelling (usually information that does not relate to safety) may be in English or other languages. In practice, these “exceptions” do not simplify translations much, so this group is like the previous one.
  • Local language is required but exceptions for professional use are possible (English or other languages), under conditions and subject to prior approval, which may be limited in time.
  • Local language is required but exceptions for professional use are accepted (English or other languages), in some cases under conditions, but without prior approval.
  • English is accepted with no limitation (i.e. for either layman or professional use).

In an effort to make the language requirements easier for manufacturers, the EU Commission has published in a bespoke webpage the below compilations:

Switzerland: a special case

Since the disruption of the Mutual Recognition Agreement (MRA) between Switzerland and the EU, Switzerland is viewed as a third country and the EU MDR/IVDR do not apply directly. However, Switzerland decided to adapt its legislation to these Regulations and follows the same principles for “labelling”. Read more about Swiss specificities here.

Article 16 §2 of the Swiss Medical Device Ordinance (SR 812.213, MedDO) and Article 15 §2 of the Swiss In-vitro Diagnostic Ordinance (SR 812.219, IvDO) require medical device labelling (understood to be labels and IFUs, per MedDO Art. 16 §1 and IvDO Art. 15 §1) to be available in all 3 official languages of Switzerland, which are German, French, and Italian. Symbols established by means of recognized standards may be used to replace plain text.

Now, MedDO Article 16 §3 and IvDO Article 15 §3 allow labelling to be provided in fewer than the 3 Swiss official languages or in English only, under all of the following conditions: 

  • The device is either supplied exclusively to professionals, is a custom-made device, or a device manufactured and used exclusively within a healthcare institution.
  • The user meets the necessary requirements (i.e. professional and linguistic) and qualifications and agrees to receive the labelling in another language (e.g. English).
  • The protection of patients, users and third parties is ensured, and the effectiveness and performance of the medical device are not placed at risk by not providing translated labelling.

These conditions are very similar in Liechtenstein, albeit for German only as national language, since both countries are tied by a Customs Treaty, RS 0.631.112.514, of which Annex I (available from Liechtenstein’s law gazette no. 280) indicates that the Swiss MedDO and IvDO apply in Liechtenstein with just a few articles being excluded.

In addition, MedDO Article 16 §4 and IvDO Article 15 §4 require that, if the user requests so, additional information must be provided in one of the three Swiss official languages.

What do labelling requirements mean for manufacturers?

Labelling management is a labor-intensive activity. Manufacturers need dedicated resources and specific processes in their Quality Management System (QMS) to ensure compliance. The processes need to include the collection of all labelling requirements (i.e. approach, format, location, contents, readability and understandability) into labelling specifications that shall guide the compilation and review of the resulting labelling materials.

Labelling requirements to collect stem from the applicable General Safety and Performance Requirements (GSPRs) in Annex I of the EU MDR/IVDR but manufacturers must make sure they also consider other applicable legislation as well as harmonized standards relative to labelling that confer presumption of conformity with the EU MDR/IVDR GSPRs.

An example of labelling management process is shown below.

In addition, the QMS must include a translation procedure that describes who is qualified to undertake translations, how accuracy of translations shall be verified (e.g. through back translations), and the process for keeping translations up-to-date, when the original version changes.

This also means that the manufacturer’s commercial release processes shall be adapted so that the devices can only be shipped or delivered to a given country if accompanied by compliant labelling.

How Decomplix can help

Decomplix provides advisory services on all regulatory and quality assurance issues related to medical devices.

Our team would be happy to assist you with regulatory compliance and specific questions regarding CE-marking under the EU MDR and IVDR, including device labelling. We continuously monitor the developments in Europe, and our team of experts is always available to assist you. If you have further questions on medical device or IVD labelling, do not hesitate to contact us.

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