Milestone Localization Launches EU MDR/IVDR Translation Planner

Milestone Localization has launched a free, interactive planner to help medical device manufacturers prepare translations for European markets. The EU MDR/IVDR Translation Planner lets users enter details about their device, choose the countries where they plan to supply it, and review language guidance for selected documents.

The new resource builds on Milestone Localization’s guide to EU MDR translation requirements. While the guide explained the subject, the planner lets manufacturers explore a scenario based on their own device and target markets.

About medical device language requirements

Manufacturers working under the European Union’s Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR) may need to provide information in different languages depending on which new markets they enter. The answer depends on the country, device class, the document and whether the device is intended for professionals or lay users.

This makes translation planning difficult when a company is preparing to supply a device in several countries. A single list of languages may not show which documents need attention or where an exception needs further review.

How the translation planner works

“We wanted to give medical device teams a practical starting point for planning translations,” said Nikita Agarwal, director and head of growth at Milestone Localization. “They can select their markets and documents, see the language guidance together, and identify questions that need to go to their regulatory team. Everything can be downloaded in an easy ready-to-use format”

The planner allows users to:

Describe the device. Users select MDR or IVDR and enter details including device class, intended users, current source language, device characteristics and regulatory route.

Choose target markets. Users can select individual destinations or use group selections for the EU, the EU plus additional European Economic Area markets, or all covered markets. The planner covers 34 assessment markets across 33 countries, including Türkiye, Switzerland and the United Kingdom.

Select documents. Users choose the materials they want to assess, such as labels, instructions for use, declarations of conformity, software interfaces and field safety notices. MDR users can also select a clinical evaluation report, a post-market clinical follow-up (PMCF) plan or a PMCF evaluation report.

Review and download results. The results are arranged by market, document and language requirement. Users can record languages already available for each document, preview a result, and download the complete plan as a table or PDF.

See where further checks are needed. The planner flags conditional requirements and cases where its sources do not give a clear answer. For CER and PMCF documents, it prompts users to confirm the receiving body’s or authority’s accepted language rather than assigning a translation requirement to every destination market.

The planner draws on published language-requirement tables and other sources identified in its results. It is intended to support early planning. It does not decide which documents are legally required for a particular device or replace a review of current national rules. Manufacturers should confirm the results and any applicable exceptions with their regulatory affairs and quality assurance teams.

How to use it

The Medical Device Translation Language Planner is available for free on Milestone Localization's website. Users can generate a language plan for their device in <5 minutes.