Medical Device Labelling Compliance Development Services
Medical Device Labelling Compliance Services
Correct labelling is not just a formality — it is a legal requirement under the EU MDR 2017/745 and other international frameworks. Our team helps manufacturers, importers, and distributors implement compliant labels that meet all safety, traceability, and language obligations. With our expertise, you can avoid regulatory penalties and guarantee patient safety.
Our Labelling Compliance Services
Regulatory Labelling Review
We review your product labels and Instructions for Use (IFUs) to verify full compliance with MDR 2017/745, ISO 15223-1, and IEC 60601 standards. This includes checking mandatory symbols, warnings, language requirements, and traceability elements.
UDI & GS1 DataMatrix Implementation
Our experts manage the Unique Device Identification (UDI) process from start to finish: Basic UDI-DI assignment, GS1 registration, and correct placement of UDI carriers (DataMatrix codes, linear barcodes, or RFID) on product labels and packaging.
Multilingual IFUs & Labelling
We prepare and translate IFUs and labels into all required EU languages and beyond. Our translations follow regulatory terminology and are validated for readability and patient comprehension.
Packaging & Environmental Compliance
We advise on correct use of recycling symbols, packaging waste obligations, and compliance with national regulations such as Spain’s Royal Decree 1055/2022. This includes Ecoembes/Ecovidrio registrations and packaging reports.
Risk & Safety Warnings
We provide tailored recommendations for precautionary statements, especially for products containing classified substances (e.g., titanium dioxide in powders). Our wording ensures alignment with CLP safety principles while remaining within cosmetic/medical device labelling rules.
Ongoing Compliance Support
We monitor regulatory updates and notify you of upcoming changes, such as new allergen declaration requirements or updates to UDI guidance. Our team ensures your documentation stays up to date at all times.
Why Choose Us?
We are a dedicated regulatory consultancy specializing in medical device compliance. With years of experience supporting European and international manufacturers, we understand the complexity of labelling rules and provide clear, actionable solutions. Whether you are launching a new device or updating an existing portfolio, we make compliance easier and faster.
- Expertise in MDR 2017/745, ISO 15223-1, and UDI regulations
- Hands-on support with GS1 DataMatrix and EUDAMED registration
- Certified translations for all EU official languages
- Tailored compliance packages for startups, SMEs, and global companies
- Continuous monitoring of EU regulatory updates
Contact us now by email at francesc@soma.cat or WhatsApp at +34 644 08 07 77 to ensure your cosmetic product meets all legal requirements and is ready for market with confidence.
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