More Product-Related Documentation

The MDR classification of medical devices has been extended to include more medicinal products, meaning that more products might be classified as medical devices than before. In addition, medical devices manufacturers are also responsible for devices once they are marketed and for the technical documentation, and there are new and more precise requirements for clinical trials to be conducted by the medical devices manufacturers.

The new guidelines also require more detailed labeling, description of the product, clinical data, documentation, software and information about application of the device, “clearly comprehensible to the intended user”.

In other words, more IFUs will need to be translated and submitted for approval to healthcare authorities for every market.

Mixed Complexity Levels

One of the particularly interesting changes related to translation refers to the manufacturer‘s responsibility to draw up the Summary of Safety and Clinical Performance in a form that intended users and patients can understand.

This means that it might be necessary to develop and translate information intended for the healthcare professionals and patients in the same document.

Focus on the User

Many of the changes required by the MDR compliance relate to the availability and clarity of the product-related documentation to the users of medical devices.

For example, the IFUs must be available on the manufacturer‘s website, linked to the Summary of Safety and Clinical Performance (SSCP) (written in or translated to the language understandable by the user) and uploaded to the EUDAMED database, and to quote from the MDR itself:

• IFUs “shall be written in terms readily understood by the intended user, and, where appropriate, supplemented with drawings and diagrams”
• SSCP must be submitted for class III and implantable devices in a language “easily understandable to the intended user”
• Labeling must be “clearly comprehensible to the intended user”
• Information supplied with the medical devices must be “easily understandable to the user”

This all means that there will be more demand for translation of patient-facing content and that having a reliable provider of language services with the appropriate experience and expertise in content production and  development of translation solutions for the medical devices sector will remain to be crucial for smooth operation and closing of regulatory cycles on the European market, and one of the reasons for this is that manufacturers now also need to provide documentation in English and in their language.

Last, but not the least, centralized management of translation services for the official languages of the EU is probably the best model for  the manufacturers of MDR-compliant medical devices because this model enables uniform execution of the translation process and the quality control across the language pairs.

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The consortium members also presented the current status of the NEC TM project and country reports and discussed the challenges they had to face during the data mining phase.

The NEC TM consortium’s objective is to organize unexploited national bilingual assets generated by public administrations. These language assets can be used as open data and general data for artificial learning.

The NEC TM project aims at providing a national and European free translation memory server that member states can use to store and use translation assets generated from public administration contracts, thus optimizing translation costs at national levels and across the EU.

We are glad that Zagreb hosted this dissemination day that presents an exciting step towards further centralization and efficient data sharing across the European Union.

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The European Commission’s aim to promote and foster digital technologies has made data generated by the public sector increasingly relevant. The NEC TM consortium’s objective is to organise unexploited national bilingual assets generated by public administrations. These language assets can be used as open data and general data for artificial learning.

In addition, the NEC TM project aims at providing a national and European free translation memory server that member states can use to store and use translation assets generated from public administration contracts, thus optimizing translation costs at national levels and across the EU.

The consortium is also working on market research, an EU-wide investigation to determine the expenditure of outsourced translations by public authorities in each member state. This research will help National Anchor Points understand the current size of public expenditure in translation services, and the amounts that can be saved by centralising data and adopting the fast-performing NEC TM database.

The NEC TM dissemination day presents an exciting step towards further centralisation and efficient data sharing across the EU.

Download the NEC TM programme 

HERE

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NEC TM Data Platform

The objectives of NEC TM Data Platform are to build a data bridge between public administration and language service providers, to promote the free flow of data between public administration and translation professionals and to act as a bridge between ELRC (European Language Resource Coordination) and European data-gathering efforts and national digital data-gathering efforts.

The NEC TM DATA consortium will deliver:

1. A central pan-European Translation Memory-sharing platform, where TMs will be shared directly among Public Administrations, LSPs and professional linguists working on translations for the public sector.
2. Versions of NEC TM at national level so that Member States can organize their language resources, categorize and classify them, and apply fuzzy matching to translation contracts.
3. An online, collaborative translation memory to which translation companies can connect during translation projects, with automatic updates of each translation phase.
4. Creation of a pan-European data-sharing awareness campaign, promoting better data-sharing practices in translation contracts between public administrations and language service providers.

NEC TM Data Platform

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The objectives of NEC TM Data Platform are to build a data bridge between public administration and language service providers, to promote the free flow of data between public administration and translation professionals and to act as a bridge between ELRC (European Language Resource Coordination) and European data-gathering efforts and national digital data-gathering efforts.

The NEC TM DATA consortium will deliver:

1. A central pan-European Translation Memory-sharing platform, where TMs will be shared directly among Public Administrations, LSPs and professional linguists working on translations for the public sector.
2. Versions of NEC TM at national level so that Member States can organize their language resources, categorize and classify them, and apply fuzzy matching to translation contracts.
3. An online, collaborative translation memory to which translation companies can connect during translation projects, with automatic updates of each translation phase.
4. Creation of a pan-European data-sharing awareness campaign, promoting better data-sharing practices in translation contracts between public administrations and language service providers.

NEC TM Data Platform

The NEC TM DATA platform will feature full text analysis, fuzzy matches, CAT-tool integration and relevant KPIs. The platform will be based on Pangeanic’s ActivaTM , which will integrate, utilize, and enhance the CEF eTranslation platform for national and European digital services.

Pan-European Data-Sharing Awareness Campaign

To promote better data-sharing practices and encourage usage of the NEC TM DATA platform, the consortium will deliver a pan-European TM-sharing awareness campaign to engage national public administrations by providing a solid framework for data sharing. Part of this effort will be through a study on translation contracts in the EU, providing an overview of the value of all national translation contracts and generated data that can be made available, plus potential savings.

Along with this study, awareness-raising info sessions will be held, where decision-makers and stakeholders at the ministry level in several countries will be made aware of the need to gather and organize translation resources.

The post Ciklopea, a Member of NEC TM Data Consortium, Wins Contract for the National European Central Translation Memory Data Platform by the European Commission appeared first on Ciklopea.