2021 saw the birth of the EU MDR regulation. This year, the EU IVDR regulation will follow. Two new regulations, two more reasons to choose Yamagata Europe as a partner for your medical documentation. Let’s take a look at what we can do for you.
In an effort to strengthen patient safety and ensure patient benefits, EU regulators are obliging manufacturers, representatives, importers as well as distributors to comply with MDR and IVDR requirements. The quality of technical documents plays an important role in these new regulations.
MDR and IVDR regulations
Both regulations are meant to bring EU legislation into line with technical advances, changes in medical science and progress in law-making. They offer a robust and transparent regulatory framework that improves clinical safety and creates fair market access for manufacturers and healthcare professionals. In a nutshell:
The new regulations replace the previous, non-binding directives 90/385/EEC (MDD) and 93/42/ECC (IVDD). The latter will remain in force until 26 May 2022.
Requirements for technical documents on medical devices
For obvious reasons, the quality level of medical documentation and translations needs to be high. However, the new regulations again underscore the importance of choosing a knowledgeable documentation partner with extensive experience in the medical industry, who can support you in your MDR and IVDR compliance efforts.
Let’s look at the four main documentation requirements imposed by the new regulations, and at how Yamagata Europe can help you meet them:
1. Traceable documents and version management
The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new MDR and IVDR regulations. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will store all available information about those devices and the companies that manufacture them.
In doing so, EUDAMED aims at enhancing overall transparency, including better access to information for the public and healthcare professionals. That’s why all documents and versions need to be traceable in their source and target languages. Content consistency is required across all language versions.
How can Yamagata Europe help?
2. Translations into 24 languages
As a manufacturer, you are responsible for translating your technical documents into each of the 24 official European languages (or at least into the language of each EU country where the device will be sold). You cannot transfer your responsibility for this to a reseller or a local company. This means that a centrally managed translation approach is needed.
How can Yamagata Europe help?
3. Translations required for CE marking
Translations now need to be ready upon application for CE marking, because they will count as a technical approval to sell your product in the EU. In other words, you will need to move document creation and translation to an earlier stage in your go to market process.
How can Yamagata Europe help?
4. Accurate and clear translations
Medical devices have a fundamental role in saving lives. To avoid faulty usage of the devices, all translations need to be clear and correct.
How can Yamagata Europe help?
Yamagata Europe always aims at offering high-quality translations that exceed our customers’ expectations. This goes for all our translators and company processes. What’s more, we can back this up with ISO 9001 and 17100 certifications and a multi-level revision and review process.
Questions about MDR and IVDR regulations?
Not sure how to adapt your document creation and translation processes to the new MDR and IVDR regulations?
