Labeling and Instructions for Use of Medical Devices: Requirements Under the MDR and IVDR

The labeling of medical devices and in vitro diagnostic medical devices, as well as their instructions for use, are part of the demonstration of conformity. Both are governed by Annex I, Chapter III, of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), respectively. The requirements are detailed and are also determined by harmonized standards for symbols, national language requirements, and the Implementing Regulation on electronic instructions for use.

In practice, complaints may arise if mandatory information is missing, symbols do not comply with standards, or translations are incomplete. Deficiencies are sometimes only discovered during an audit or as part of market surveillance. Rectifying these deficiencies can then be time-consuming because the label, packaging, and technical documentation must all be updated simultaneously.

Current developments include, on the one hand, electronic instructions for use - which received approval in 2025 for a significantly wider range of product types - and, on the other hand, a harmonized, revised symbol standard effective in June 2026 that affects the symbol for the authorized representative. This article clarifies which requirements apply and what practical considerations must be taken into account.

Labeling of medical devices: legal framework

The relevant requirements can be found in Annex I, Chapter III of the MDR (Section 23) and Annex I, Chapter III of the IVDR (Section 20). Both chapters are part of the general safety and performance requirements (GSPR). Compliance with these requirements is therefore a prerequisite for the declaration of conformity and involves more than just a downstream packaging step.

Particular attention should be paid to:

Risk management: Labeling and instructions for use are part of risk control. Safety-related information on residual risks, warnings, and precautions arises from risk management in accordance with ISO 14971 and must be provided in accordance with Annex I, No. 4 of the MDR/IVDR.
Usability: Labeling, instructions for use, and other user information must be understandable to the intended users. This must be taken into account in accordance with Annex I, Chapter I, No. 5 of the MDR or IVDR and is typically demonstrated through the application of IEC 62366-1.
CE mark: This is regulated in Article 20 of the MDR and Article 18 of the IVDR, as well as in the respective annexes on CE marking. If a Notified Body is involved, its identification number appears next to the CE mark.

The required information on the label and in the instructions for use is determined by the intended purpose. This must be described consistently in all regulatory documents.

Label: mandatory information on the label

Annex I, No. 23.2. of the MDR and No. 20.2. of the IVDR list the mandatory information on the label. The following overview summarizes the most important practical points.

Information	Note
Product name, identification details	Trade name and all information necessary to identify the product and its contents
Manufacturer and address	For manufacturers outside the EU, also the authorized representative
UDI carrier	In accordance with Art. 27 MDR or Art. 24 IVDR and Annex VI, Part C
Lot or serial number	For serial products, often a lot number, for implants and active devices, often a serial number
Expiration date, storage conditions	To the extent necessary for safe use
Sterile status, sterilization method	Including information on the integrity of the sterile packaging
Single-use device	Labeling as a single-use product
Warnings, precautions	In a clearly visible form
Certain substances	Substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) and endocrine-disrupting substances at concentrations above 0.1% as specified in Annex I, Section 10.4.5 of the MDR
Nanomaterials	To the extent that information subject to labeling requirements is necessary
Intended purpose	If it is not obvious to the user

For IVDs, additional requirements apply, such as information on calibrators and control materials, as well as labels for devices for self-testing and point-of-care testing.

Contents of the instructions for use

Annex I, No. 23.4 of the MDR and No. 20.4 of the IVDR govern the content of the Instructions for Use (IFU). They include the relevant labeling information and, in particular:

Intended purpose, intended patient group, and intended users
Performance characteristics, as well as the expected clinical benefits for products subject to the MDR or the relevant performance data for IVDs
Residual risks, contraindications, side effects, and warnings
Instructions for preparation, installation, calibration, and combination with other products
Information on reprocessing for reusable products
Information on reporting serious incidents, where applicable
For implantable devices, the information required under Article 18 of the MDR, including the Implant card
Reference to the summary of safety and clinical performance (SSCP) for Class III and implantable devices
Date of issue and revision status

In accordance with Annex I, Section 23.1(d) of the MDR, instructions for use may be omitted for Class I and IIa products if safety is ensured even without them. This exception must be justified and documented, typically through the fitness-for-use dossier.

Symbols and harmonized standards

Annex I, Section 23.1(h) of the MDR and Section 20.1(h) of the IVDR require that information be provided in the form of internationally recognized symbols. If symbols are used, they should comply with harmonized standards. If their meaning is not readily understandable to the intended users, it must be explained in the accompanying information. The applicable standard is EN ISO 15223-1:2021, which has been harmonized under the MDR and IVDR since January 2022.

In June 2026, the European Commission harmonized the amendment EN ISO 15223-1:2021/A1:2025 - for the MDR via Implementing Decision (EU) 2026/1231 and for the IVDR via Implementing Decision (EU) 2026/1313. The amendment adds a definition for the authorized representative and makes the previous EC-REP symbol region-independent. For the EU, this becomes “EU REP.” As things stand, the presumption of conformity under the previous version will cease to apply on June 15, 2031 (MDR) and June 17, 2031 (IVDR). The need for adaptation is widespread because many CE-marked products bear this symbol. The transition period allows for the change to be implemented as part of already planned updates to labels, packaging, and instructions for use.

In practice, EN ISO 20417 often serves as a guideline for creating labels and instructions for use. It specifies many information requirements of the MDR and IVDR. However, as things stand, it is not harmonized under either the MDR or the IVDR. It can be used as a reference for the state of the art but does not establish a presumption of conformity.

Language requirements

Pursuant to Article 10(11) of the MDR and Article 10(10) of the IVDR, Member States determine the languages in which product information must be provided. The requirements therefore vary depending on the target market. The European Commission provides an overview of the national requirements in this regard. For products distributed throughout Europe, this often results in multiple language versions of labels and instructions for use.

In Germany, Section 8 of the MPDG (Medizinprodukterecht-Durchführungsgesetz, Medical Device Law Implementation Act) applies. According to Section 8(2) of the MPDG, products may only be supplied if the information intended for users and patients is available in German. In justified cases, English or another easily understandable language is permitted if the information is intended exclusively for professional users and the safety-related information is additionally available in German or in the user’s language. For implantable devices, Section 8(3) of the MPDG requires the information specified in Article 18 of the MDR to be provided in German. According to Section 8(1) of the MPDG, the EU declaration of conformity must be available in German or English.

The translation and release of labels, instructions for use, and other product information are part of the quality management system. It is advisable to maintain a documented source version, conduct a technical review of the translation, and manage the language versions separately.

Electronic instructions for use (eIFU)

For medical devices, Implementing Regulation (EU) 2021/2226 specifies when the instructions for use may be provided electronically rather than in paper form. Amending Regulation (EU) 2025/1234 entered into force on July 16, 2025, and expanded the Scope:

The eIFU may be used for medical devices and their accessories, provided that the requirements of the regulation are met and the instructions for use are intended exclusively for professional users.
For lay users, the paper format remains mandatory. An exception is software for which the instructions for use can be provided via the software itself.
The manufacturer must review the risks associated with the electronic provision of the instructions for use and ensure that the website through which the eIFU is provided meets the relevant requirements.
A paper version must be provided free of charge upon request and within the prescribed time limit.
The URL where the eIFU is available must be listed in the EUDAMED UDI database no later than the date on which registration of the products in EUDAMED becomes mandatory.

The eIFU Regulation does not apply to IVDs. Instead, Annex I, Chapter III, No. 20.1(f) of the IVDR contains specific requirements regarding the provision of instructions for use and other product information, particularly for products intended for professional use.

Label and instructions for use in change management

Changes to labeling and instructions for use must be reviewed from a regulatory perspective and implemented as part of the QMS. In doing so, it must be determined whether the changes have an impact on the conformity assessment or must be notified to the Notified Body. For legacy devices, the relevant transitional provisions of the MDR and IVDR must also be taken into account. Potential impacts on UDI, registrations, language versions, and the technical documentation should also be part of this review.

Findings from post-market surveillance (PMS) may necessitate adjustments to labels or instructions for use, for example, due to newly identified risks, errors in use, or safety-related incidents. Field Safety Notices (FSNs) are used to promptly inform users about newly identified risks or necessary measures. They do not replace the required updates to Labeling or instructions for use.

Practical approach

Create a matrix that links each mandatory requirement from Annex I, No. 23 of the MDR or No. 20 of the IVDR to the “location” of its implementation (label, packaging, IFU, software interface).
Maintain a symbol index that maps each symbol used to the harmonized standard version and describes non-standardized symbols.
Plan language versions for each target market, including the approval process within the QMS, version control, and documentation of technical review.
Before making a decision on the eIFU, perform testing of the prerequisites with regard to the user group, risk evaluation, website, paper version upon request, and EUDAMED registration.
The transition to the new symbol for the authorized representative should be taken into account during the next revision of labels, packaging, or instructions for use.

FAQ

Is the instructions for use part of the technical documentation?

Yes. The approved version is part of the product’s technical documentation.

Can a set of instructions for use cover multiple product variants?

Yes, provided that all variants are correctly described and no misunderstandings arise.

Do the warnings on the label and in the user manual have to be identical?

No. However, they must be consistent with each other and must not contradict one another.

When is it necessary to update the user manual?

When new risks, product changes, or new regulatory requirements make it necessary.

Can QR codes be used on labels?

Yes. They can supplement information but generally do not replace mandatory information.

Conclusion

Labeling and instructions for use are more than just formal documentation requirements. They translate the intended purpose, risk management, and regulatory requirements of the MDR and IVDR into concrete product information. Systematically maintaining labels, symbols, language versions, and instructions for use helps prevent complaints and ensure conformity throughout the entire product lifecycle.

If you would like to review your label and instructions for use against current requirements, we can assist you with a gap analysis. Please feel free to schedule an initial consultation.