The European Medical Device Regulation was officially passed back in May 2017. However, the new enforcement obligation leaves many with doubts. The regulation stipulates that every medical product needs to be accompanied by an MDR certificate before approval, marking a significant change to the approval process of medical devices in the EU. The goal is to improve the safety and transparency of medical devices for consumers and users while eliminating differences from one EU country to the next. The Medical Device Regulation not only introduced classification rules, concepts, and definitions, but also new process-oriented requirements on the approval of medical devices.
The regulation is highly complex, and mastering it is a challenge that manufacturers have to grapple with. In Europe, there are over 500,000 registered medical technologies and 25,000 registered MedTech companies. Of these, 95% are small or medium-sized enterprises, who have to reorganise themselves.
What visible changes does the process bring about?
The new regulation replaces the EU directives on active implantable medical devices and the Medical Devices Directive. The problem with these directives revolved around the differences in their interpretation and implementation across EU countries, even though they were passed at the EU level.
The new regulation poses big administrative challenges. It emphasises linguistic diversities and requires that user instructions as well as all texts associated with medical products must be available in — and therefore translated to — all 24 official languages of the European Union. This will be decisive for European market approval of devices. To name an example, this applies to all packaging and labelling of medical products.
The underlying intention is transparent and benefits consumers: texts must be clear and easy to understand for the consumers of devices, to ensure safe and proper use. In today’s globalised society, this is very sensible in order to not only comply with applicable European law, but also to guarantee and strengthen trade across Europe.
The new process is vastly different from the way in which the approval process for medical devices has been handled so far: translations were previously not part of approval and were often only created once approval was granted. The new regulation, however, specifies that user instructions must be approved as they are part of the technical documentation. This includes all 24 translated versions.
This imposes a big challenge for developers and distributors of medical devices — since they are solely responsible for legal conformity. The only option they have is to adapt and adjust their labeling through expensive restructuring measures — covering all 24 official languages — or to discontinue their device. There is no grandfathering provision in place for products that have already been approved. Any approvals granted before the enforcement date in May 2021 will only remain valid for a maximum of four years, after which they will have to go through the same compliance evaluation process to which new products are subject. This is why it makes sense to use the adjustment phase to update the technical documentation process, make them more effective, or change them if need be. This simplifies compliance with the regulation when it enters into full force. A good localization partner can guide you through this process.
lengoo as a supportive partner
To make sure your company’s localization processes run as smoothly as possible, lengoo offers full-service localization to help you meet the new compliance requirements without a hitch. At first glance, 24 languages might seem like a lot. This is why lengoo offers all translations on one platform and at a fair price. With the assistance of revolutionary MT technology, we can translate texts up to three times faster with prices up to 50% lower than traditional translation providers. You no longer need to worry about the lengthy or expensive processes necessary in order to adapt to the new regulation and can, instead, focus on the range of opportunities these translations offer to your company. They not only make your products safer and more transparent, but also help you tap into new markets and find new customers. Schedule an appointment today to make sure your company is meeting the new and binding compliance requirements.