Since 2017, the European Union has been designing a series of new regulations directed to improve the safety of medical devices (MDRs) and in vitro diagnostic medical devices (IVDRs). 2022 will be the year when some of them will be implemented and, an essential part of this process relates to patient centricity.

But perhaps while you read this you are wondering, what does patient centricity mean?, why should I prioritize it? In the following article, we will discuss what patient-centricity is, why it is important to implement it, and how translation plays an essential role in helping to achieve it.

What is patient centricity and what does it entail?

Patient centricity is an approach the healthcare system takes toward patients to align with their decisions, needs, and preferences. It can consist of different practices depending on each company, ranging from seeking patients’ opinions on healthcare protocols to asking for their participation in the design of drug packaging. 

In current times and in relation to new EU regulations, patient-centricity has gained more and more relevance. It is now thought to be more significant to put the system at the service of the patient experience and not vice versa. This has to do with the fact that the patient experience can nowadays be tracked more effectively and also that the rise of the internet has allowed patients wider access to the medical system, giving them more opportunities to inform themselves and take control of their health. 

This has led to a paradigm shift generated in the healthcare system, where doctors, pharmaceutical, and health companies no longer base their actions exclusively on results obtained in tests, but on the personal experience they obtain from patients. Thus, the patient-centered approach consists of offering special medical services designed to meet the patient’s values, needs, and preferences, accompanied by professional consultations and guidance from health experts. 

Why is it necessary to prioritize patient centricity?

In addition to highlighting the relevance of further humanizing the medical treatment of patients and expanding their knowledge in the functioning of the medical devices they use, there are other reasons to understand why it is necessary to prioritize patient-centricity according to normative and ethical aspects.

Regulatory aspect

According to the new EU regulations, each medical, pharmaceutical, or healthcare company engaged in the manufacture, distribution and, use of medical devices must upload to the European Database for Medical Devices (EUDAMED) information on each medical device placed on the market. This includes economic operators and certificates issued by notified bodies. More detailed labeling and electronic manuals will increase user-friendliness.  

This means that the EU will focus on the benefit of patients and on ensuring the greater safety of the medical devices available to them through detailed and truthful communication. If companies do not comply with this series of requirements, they will not be approved by the new regulation.

Ethical aspect

On the other hand, from an ethical perspective, the EU sees the need to provide all the necessary information to patients more transparently and accurately (quality, control, and compliance) throughout their life cycle and supply chain. 

What role does translation play in patient centricity?

From the requirements established by the EU, translation happens to take an essential role since to provide better communication to the patient; it will be necessary to meet several demands of this service. Among them:

• 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 made available. Depending on the extent of the product’s presence in the EU, up to 24 languages are currently required for translations.

• Before these new regulations, translations used to be required after a medical device received CE marking (the legal requirement for marketing a medical device in the EU), but now translations of documents such as instructions for use (IFU) must be submitted as part of the technical dossier required by notified bodies for conformity assessment. Also, to comply with the new requirements, translation must be considered earlier in your workflow.

• Effective and timely translations are now an essential component of medical device sales in the EU. The translated data will be stored in a European database.

As mentioned above, one of the key developments related to the new regime is the creation of EUDAMED, a central European database that will store information on all medical devices sold in European markets, ensuring that data in all applicable languages can be recorded and exchanged. 

Therefore, when approved by these new regulations, companies will have to rely on a translation service that can use client-based content management systems and have its own translation management system. This will ensure that translations are consistent, and their work can be monitored accordingly.

Win & Winnow has almost 20 years of experience providing translation services. We have a highly qualified team to provide our clients with complete and customized solutions in over 100 languages. Contact us to learn how we can help your company comply with these new regulations through a quality translation service.