The European Union (EU) is about to implement new regulations concerning medical and in vitro devices called: the MDR regulation and the IVDR regulation. One of the important points that both companies and medical providers will have to take into account is the implementation of an efficient, fast and professional translation service.
In the following blog, we will see what these new regulations are about, what impact they will have on the European medical system, and why translation will play a key role in their implementation. Let’s get started!
What are the EU MDR/IVDR?
They are the new regulations that will serve as a replacement for the previous Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). Although both the MDR and IVDR were set to be implemented during 2020, the COVID-19 pandemic delayed their process and they are expected to come into force from 2022.
The main thing to consider about these regulations is that they will be focused on safeguarding patient safety and ensuring the correct use of medical devices. This also means that all devices marketed within the EU will need certification or recertification that complies with the new regulatory parameters.
All this means that patients and users will need to be able to rely on an accurate understanding of the information about the products they will be using, as well as being able to obtain clear instructions for use. However, this poses a challenge for healthcare companies.
What’s new about MDRs/IVDRs?
As mentioned above, the new regulations emphasize transparency and traceability in devices. Let’s take a closer look:
- Quality management system: medical device manufacturers must, under the new regulation, establish and implement documentation within the EU-mandated quality management system (QMS).
- Unique device identifier: To seek easy traceability of all existing medical devices within the EU, they must be marked with a unique device identifier (UDI) on their labeling and packaging. Likewise, this identification must be registered in the EU’s central database called EUDAMED.
In turn, manufacturers and/or suppliers will receive annual audits to verify compliance with regulations and ISO 13485:2016 standards. Similarly, clinical evaluation reports (CERS) will be carried out in a much stricter manner.
According to the Notified Bodies for Medical Devices (NB-MED), translations must be accurate so manufacturers must ensure that a reliable and quality translation process is performed.
What are the new translation requirements set out in the MDR/IVDR?
Because the EU is made up of different countries, the new regulations implicitly require that the information they set out must be well translated. If this does not happen, the devices will not be able to receive their CE certification. In addition, there are other reasons why quality and professional translation service should be taken into account:
- Clarity and quality standards: A company needs to be able to rely on trustworthy translation resources that can handle the broad scope of translation demands that will be imposed by the EU. The range of content and its variety will be extensive and therefore investing in a quality service that can meet the deadlines of the new regulation will be critical.
- Translations will have to be provided in more languages: Medical device companies operating in the EU will have to provide more detailed and accurate product descriptions in more languages. Technical documentation will also have to be translated into all languages of the EU country (or countries) in which the product is to be sold or marketed. Depending on the scope of the product in the EU, up to 24 languages are currently required for translations.
- The translated information will be uploaded to the EUDAMED database: As one of its parameters, the MDR will require device manufacturers to store the information in the European EUDAMED database. For this, translation service providers will have to have their Translation Management System, which can be performed by an agency that certifies a consistent and traceable result.
- Translations will be required before CE marking: To comply with the new requirements, manufacturers will have to provide translations of their devices before receiving their CE marking. Translation of documents such as instructions for use, for example, must be provided as part of the dossier for conformity assessment by notified bodies before marketing and distribution.
Working closely with a translation and localization provider that specializes in the life sciences sector, is familiar with medical and technical terminology, and is ISO certified, is an important step in conquering the ever-changing international regulatory process. The choice of translation provider is vital to ensure accurate, consistent, efficient, and technically correct translations.
We support you in your global expansion strategy.
Win & Winnow is an ISO-certified translation company that meets professional quality standards to accompany you in the translation process required by the new MDR-IVDR regulation. We have a team of professional linguists with experience in technical and medical documents; especially in the management of regulatory documentation.
If you would like to learn more about our services, do not hesitate to contact us by clicking here.