Medical Device Labelling
MDR-compliant labels and IFU with the correct symbols, UDI and CE marking, reviewed for Notified Body approval.
Regulatory Expertise
In-depth knowledge of EU MDR and the global regulatory landscape.
Practical Compliance Support
Actionable solutions tailored to your product and business needs.
Documentation Guidance
Clear, structured and audit-ready documentation support.
Market Access
Smooth and safe access to the European market.
What Is Medical Device Labelling Under EU MDR?
Medical device labelling is defined in Annex I, Chapter III, Section 23 of the MDR (“Label and instructions for use”). It covers two closely linked things: the label itself, the information printed on or fixed to the device, its packaging, or the packaging of multiple units and the Instructions for Use (IFU), which give the fuller information a user needs to operate the device safely.
Labelling is part of the General Safety and Performance Requirements (GSPR): it is not optional documentation you can add later, it is evidence a Notified Body checks as part of your technical file before CE marking is granted, and it must stay consistent with the rest of that file the intended purpose on your label has to match the intended purpose in your clinical evaluation and risk management file.
Services
- Technical Services For Design And Development Of Medical Devices
- QMS Development and Support
- Risk Management Service
- Technical Documentation Service
- General Support
- Audit Readiness Plan
- Design Control Requirements for Drug-Device Combination Products
- EU Medical Device Regulation
- Medical Device Testing Service
MDR Labelling Requirements
Under Annex I, Chapter III, Section 23, your label must include:
Manufacturer & Identification
Manufacturer or Authorised Representative name and address, the CE mark with the Notified Body number, and the device name, model or catalogue number.
Device Content & Purpose
The device's intended purpose, and the name, strength and quantity of any active substances it contains.
Safety & Handling
Warnings, precautions and contraindications, special storage or handling conditions, and any special operating instructions.
Dates & Traceability
Shelf life or expiry date, or the date of manufacture if no shelf life applies, and a Unique Device Identifier (UDI) on the label, packaging and IFU.
Information must appear on the device itself where practicable; if that is not feasible, it can move to the individual or outer packaging. It must be in a human readable format and may be supplemented, but not replaced, by machine readable formats such as barcodes or RFID.
Medical Device Symbols and Harmonised Standards
A practical way to cover multiple language markets on one label without redesigning it for every country. The main harmonised standards for these symbols are:
EN ISO 15223 1:2021
medical device symbols for labels, labelling and information to be supplied (general requirements)
EN 1041:2008
information supplied by the manufacturer of medical devices
EN 15986:2011
labelling requirements for devices containing phthalates
EN ISO 3826 2:2008
graphical symbols for collapsible plastic containers for blood and blood components
What Counts as Labelling
“Labelling” under the MDR covers more than the sticker on the box. It includes:
- The label on the device itself and on its packaging
- Instructions for Use (IFU)
- User manuals
- Safety information and warnings
- Accompanying software, where the device includes it
- Marketing materials such as leaflets and brochures, where they carry information relevant to safe use
Any of this that reaches a user in an EU market must be available in a language, and format, that user can understand.
Our Medical Device Labelling Services
- Label and IFU content review against Annex I, Section 23, mapped to the same GSPR checklist template we use across your technical file, so labelling evidence is never a separate afterthought
- Symbol selection and justification against EN ISO 15223 1:2021 and related harmonised standards
- UDI placement and formatting across label, packaging and IFU
- CE mark and Notified Body number placement as your CE marking consultant, we make sure labelling meets this condition of certification alongside the rest of your CE marking service
- Multi market language and symbol strategy, so one label design can cover several target countries
- Usability checks on label and IFU wording, coordinated with our broader medical device validation services where formal usability testing is needed
- Consistency checks between your labelling, IFU, risk management file and clinical evaluation
Our Process
Manufacturers most often run into:
- Review: we check your existing label, IFU and packaging text against Annex I, Section 23.
- Gap mapping: missing or inconsistent content gets flagged against your GSPR checklist and technical file.
- Symbol and standard selection: we confirm which symbols apply, and cite the harmonised standard behind each one.
- Language and market check: we confirm labelling meets the language requirements of each country you're targeting.
- Integration: we cross check the final labelling against your risk management file and clinical evaluation, so nothing contradicts the rest of your technical documentation.
Subhash Meena
Medical Device & Drug-Device Combination Product Expert
Why Choose 3i Concept
Our EU MDR consulting work is led by Subhash Meena, a Medical Device and Drug-Device Combination Product expert with 15+ years of experience. He has worked across Meril Life Sciences, Sun Pharmaceutical Industries, Amneal Pharmaceuticals and Dr. Reddy’s Laboratories, spanning cardiology, orthopaedics and endosurgery.
His experience includes combination products such as pen injectors, auto-injectors and prefilled syringes, with direct Notified Body and USFDA filing experience. For manufacturers in India and worldwide, that means an EU MDR consultant who has done the work from inside the industry.
15+
Year of Experience
4
Leading Companies
NB + USFDA
Direct Fillings
Frequently Asked Questions
All the information a manufacturer supplies with a device to ensure safe use the label on the device and its packaging, the Instructions for Use, and related safety information as defined in Annex I, Chapter III, Section 23 of the MDR.
Yes. Labelling that meets Section 23 is a condition of CE marking under the MDR, alongside the rest of your technical documentation.
At minimum: manufacturer or Authorised Representative details, CE mark and Notified Body number where applicable, device name and model, intended purpose, warnings, storage conditions, shelf life or date of manufacture, and a Unique Device Identifier (UDI).
Yes, under GSPR clause 23.1(h), provided the symbols follow a harmonised standard such as EN ISO 15223 1:2021. Written information such as warnings and IFU content still has to be provided in the languages of the countries where the device is sold.
The core standard is EN ISO 15223 1:2021, alongside EN 1041:2008, EN 15986:2011 for phthalate-containing devices, and EN ISO 3826 2:2008 for blood collection containers.
Yes. The intended purpose, warnings and classification information on your label must be consistent with your risk management file, clinical evaluation and the rest of your technical file — inconsistencies are a common reason Notified Bodies raise queries.
Yes. We review your current labelling and IFU against Annex I, Section 23, identify gaps against the GSPR checklist, and bring them in line with the rest of your technical documentation.
Looking For General Support For Your Medical Business?
Let’s discuss your upcoming project.