Adapting to New Medical Device Regulations: The Vital Role of Translation Service Providers

In the dynamic realm of medical device regulations, staying proactive and informed about regulatory changes is crucial for both manufacturers and service providers. To improve safety, compliance, and transparency in the European market, major changes have recently been introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Adapting to these new MDR underscores the vital role of medical device translation service providers.

The role of translation service providers in navigating the new MDR regulations cannot be overstated. Language providers that comply with ISO 13485, ensure translations that meet MDR standards, offering assurance to manufacturers and service providers. As translation becomes a fundamental part of the medical equipment lifecycle, from patent filing, user and installation manual, labelling and packaging to marketing materials, it is essential that our language solutions improve hand in hand with regulations, ensuring seamless integration and compliance with the highest quality standards.

Ensuring Compliance in Diagnostic Device Oversight

In the first place, significant changes to diagnostic device oversight, particularly in terms of risk assessment and management. With roughly 80% of devices now subject to assessment by notified authorities, the workload has increased, exacerbating difficulties including a shortage of authorized bodies and manufacturer readiness. This raises the potential of shortages, particularly of high-risk equipment. Proposals to lengthen transitional periods aim to provide a breathing space, while emphasizing the significance of long-term solutions to ensure regulatory robustness and device availability.

Secondly, to increase information openness and accessibility in the medical device industry, guidelines established in 2017 authorized the construction of the European database on medical devices (EUDAMED), which is intended to collect full data on all devices sold in Europe. Initially, manufacturers were not required to register their devices with EUDAMED until all operational requirements were completed. Three modules are already available, with two more planned by 2024 and the final module set to be completed in late 2027. To expedite the registration process, new laws will necessitate mandatory product registration via full EUDAMED modules commencing in late 2025.

Furthermore, the latest version compels manufacturers to provide advance notice before discontinuing the supply of critical medical equipment or IVDs. This requirement aims to limit risks to patient safety and public health by mandating rapid communication among relevant authorities, health institutions, healthcare practitioners, and economic operators impacted by device supply disruption. By proactively notifying stakeholders, manufacturers help to assure continuity in healthcare delivery and prevent disruptions in medical device availability, thereby protecting patient well-being and public health.

Strengthening Healthcare Continuity with SeproTec

To conclude, the shifting regulatory landscape for medical devices needs rapid adaptation and rigorous compliance from both manufacturers and medical device service providers. As a key player in this dynamic environment, SeproTec is at the forefront of regulatory adaptation, offering not just comprehensive language services but also strategic compliance solutions. Our expertise and ISO 13485 certification ensure translations meet the highest standards, helping medical device manufacturers to maintain safety and to comply with new legislation.

Our dedication to quality and precision in translations allows for smooth integration into the regulatory environment, increasing transparency and efficiency in medical device paperwork. As the sector moves toward a more stringent regulatory future, SeproTec’s customized language solutions and proactive approach become more important than ever. Adjusting to new medical device regulations with translation service providers is essential for seamless compliance and continued success in the evolving regulatory landscape. Our goal is to provide clients with the resources they need to efficiently manage these changes, while maintaining patient safety and product reliability.

SeproTec Multilingual Solutions will be exhibiting at #MedTecLive, to be held in Stuttgart from June 18^th to 20^th. Please contact us at sales.europe@seprotec.com for a voucher code, which you can redeem online, to access the event free of charge.