It has been regarded as the ‘gold standard’ for the production of medical devices around the world. But what exactly is the EU MDR ?
It is a new list of regulations which oversees elements of production and distribution involved with medical devices throughout Europe. Meaning medical device suppliers who sell their products in the European marketplace must comply with this set of regulations. Such measures will replace the existing MDD (Medical Device Directive). The main objectives of the MDR are clear. Improve the safety, standards and accuracy of labelling on medical devices. Overall this shall help to promote more transparency in translation via a more ‘life-cycle’ approach to the process. Therefore, information is clear and concise for users of the Member State languages.
Manufacturing and translation requirements
For manufacturers, the requirements will include managing the storage of documents, post-market surveillance, and risk assessments of both new and existing devices. In all cases, manufacturers must include a Summary of Safety and Clinical Performance (SSCP) alongside the technical documentation. All of which will be submitted for a conformity assessment. This will be during the pre and post market launch. With increased medical translation demands, key documents will require translation. Some examples will include implant cards, transport packaging, technical and regulatory documents and IFUs. For LSPs, the new translation requirements are as follows:
- Translators from all 24 EU Languages will be required.
- Wider scope of specialised content needing translated.
- Adjustments to timeframes involved in translation.
- Before CE marking, translations of official documents for conformity assessment.
- Information from source and translated target texts to be clear.
- Careful management of translated content stored in EU database.
It is essential that both medical device manufacturers and LSPs collaborate to comply with these regulations. This is to enable medical device market continuity, transparency and promotion of a more patient-centric approach.
The effectiveness of the regulations so far
In evaluation of the regulations, one issue is the impact on symbols and icons. Symbols that indicate a device as medical, containing hazardous substances, or indicate a device as single-use may need to be updated. Delivering these specialized translation services requires both in depth technical knowledge with the expertise to create transparent content in the Member State language. Partnering with linguists who are trained under these new requirements is critical for EU MDR compliance. In failing to produce accurate labelling for MDR or any other information required, there will be repercussions. This may mean a delay of product entry into the market or even result in a product recall.
Another issue is the delay in the implementation of MDR compliance due to COVID-19. The date originally set was 22nd May 2020. But the European Council and European Parliament have announced a delay of one year to the MDR application until 26th May 2021. This allows some specialised businesses, already on the market to concentrate time, effort and resources on the impacts of the pandemic. It is still uncertain when they will revert back to normal operations in time for May 2021.
On a positive note, translation work projects will increase for LSPs. Therefore, such providers are taking steps to meet the criteria for the MDR. This refers to the provision of more translation services for content types. Examples include labelling, reports for assessment and inspection, localisation and testing services before product promotion. They are helping to translate field safety notices and give workflow solutions to suit the medical supplier’s business needs under such regulations. Furthermore, translators are offering medical and clinical linguistic expertise by translating clinical investigation plans. These plans will then be widely available in all Member State languages.
While a stricter regulatory framework is a burden to manufacturers, it is a boom to the language industry. As illustrated above, these new rules will create additional opportunities for specialised providers.