EU MDR Transition Services for Indian MedTech Exporters
White Globe delivers ISO 13485-certified IFU localisation, SSCP translation, and technical file documentation across all 24 EU official languages — built specifically for Indian medical device manufacturers.
EU MDR Transition Deadline Tracker
Days remaining as of today — recalculated every time this page opens
The Challenge
Every CE-marked device sold in Europe must now comply with EU MDR 2017/745 — and language is where most Indian manufacturers are underprepared.
EU MDR Article 41 and Annex I Section 23 require all Instructions for Use to be available in the official language(s) of every EU member state where the device is sold. A single product distributed across 10 countries may require 12+ language versions.
The Summary of Safety and Clinical Performance (SSCP) is mandated for Class III and implantable devices under EU MDR Article 32. It must be available in all relevant EU languages and validated by the Notified Body.
Device Master Files, Risk Management Reports, and Clinical Evaluation Reports may need to be submitted or accessible in the working languages of Notified Bodies — typically German, French, or English depending on the NB.
MDR requires post-market surveillance reports (PSUR), periodic updates to IFUs, and vigilance reports — all of which require ongoing multilingual updates throughout the product lifecycle, not a one-time translation.
Who We Serve
We work with Regulatory Affairs, Quality, and International Business teams at India's leading MedTech companies.
Our Services
Delivered by ISO 13485-certified specialists — not generalist translators.
Core Requirement
Instructions for Use and Directions for Use translated, edited, proofread, and formatted into up to 24 EU languages — with regulatory symbol preservation and DTP.
New MDR Requirement
Summary of Safety and Clinical Performance localisation per MDCG 2019-9 guidance — with separate lay-person and healthcare professional sections in each required language.
Label Compliance
Multilingual label text, packaging inserts, and carton content aligned to EU MDR Article 23 requirements — including UDI label content creation.
Technical Documentation
Device Master File, Plant Master File, and Risk Management Report translation for Notified Body submission — with ISO 14971 alignment.
Clinical Documentation
Clinical Evaluation Reports, clinical investigation documents, and back-translation for data validation — handled by specialist medical translators.
Post-Market
Periodic Safety Update Reports and Post-Market Surveillance reports — translated on an ongoing basis to meet MDR's lifecycle documentation obligations.
Digital & Software
Software as a Medical Device interface localisation — screen labels, error messages, and GUI text — per CDSCO Oct 2025 draft guidance and EU MDR SaMD requirements.
Lifecycle Management
All work is stored in your dedicated Translation Memory on our Lang Tech platform — reducing costs by 30–60% on every subsequent update, version, or new market.
How It Works
A structured, repeatable programme — not a one-time project.
Our Credentials
Quintuple ISO certification means every part of your documentation programme — translation, quality, security, and AI oversight — is governed by an independently audited standard.
Quality system specifically for medical device documentation processes — directly maps to EU MDR technical file requirements
The international standard for translation quality — mandates TEP workflow with qualified translators and independent review
Protects your confidential technical files, clinical data, and proprietary device specifications during the translation process
End-to-end quality management across all project types — from scoping to delivery to lifecycle updates
Governs AI-assisted translation with mandatory human post-editing — ensuring speed without compromising regulatory accuracy
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Indicative Pricing
Formal quotes issued after document review. Volume pricing and dedicated programme rates available for multi-product engagements.
| Service | Indicative Rate |
|---|---|
| Standard IFU / Label translation (EN → major EU language) | ₹2.40 – ₹3.30 per source word |
| Regulated technical document (TEP + QA + ISO 13485 sign-off) | ₹3.90 – ₹4.80 per source word |
| SSCP translation per language | ₹42,000 – ₹87,000 per language |
| DTP / multilingual layout (per page) | ₹500 – ₹1,500 per page |
| Translation Memory savings on repeat / updated content | 30–60% cost reduction |
| 24-language EU pack (IFU + Label) | Custom volume quotation |
All pricing is indicative and subject to volume, turnaround, language pair complexity, and document type. A detailed quote is provided within 24 hours of document receipt.
Get Started
Share your product list and target EU markets. We will respond with a scoping proposal and indicative quote within 24 hours.