On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s implementation in 1992, there have been many changes to the industry that require an update to address new technology and innovative devices increase transparency for all stakeholders while maintaining safety and efficacy standards, as well as improve medical device manufacturers’ responsibility for the product lifecycle to address the aging population. The transition period was originally set to end in May 2020, however due to the global COVID-19 pandemic the timeline was extended, which came as a relief to many medical device developers that are still working on the proper implementation of the new regulation in their manufacturing process. With the new deadline fast approaching, there are crucial elements to the MDR that medical device companies must be aware of to gain regulatory compliance for marketing their products in the European Union (EU).
The world has become increasingly more digital since the original release of the directives in 1992; with new technologies such as wearable devices, AI advancements, mobile apps, and other medical technologies progressing rapidly, the way patients are diagnosed, treated, and monitored have changed drastically over the course of two decades. To address the technological innovation, specifically to include the regulation of software as a medical device (SaMD), the MDR brings serious changes from the MDD, including broadening the definition of what classifies a medical device. According to the MDR, a medical device is defined as “any instrument, apparatus, appliance, software, implant, reagent, material or other article” that is intended to be used to:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state
- Providing information by means of in-vitro examination of specimens derived from the human body, including organ, blood and tissue donations
The MDR also included devices that are intended to control or support contraception, as well as products meant to sterilize or clean any of the aforementioned medical devices. In addition, the new regulation contains 16 Annex sections that are meant to address a lot of the gaps from the MDD, for example, contact lenses, liposuction equipment, silicone breast implants, and more.
It is extremely important for medical device manufacturers and companies involved to conduct a gap analysis between the MDD and MDR for better clarity on the changes, or work with companies that have in-depth knowledge of the changes. By doing so, they will have a better understanding on how to best update their regulatory strategy depending on their product, including planning and prioritizing different regulatory pathways, which is crucial for gaining market access and regulatory compliance in the most timely and cost-efficient manner.
In addition, changes to the quality management system (QMS) that medical device manufacturers have in place are necessary to ensure that they follow “General Obligations” set by the MDR. These modifications are meant to increase transparency for consumers, regulators, manufacturers, and all other involved parties, as well as improve harmonization between other regulatory bodies like the U.S. Food and Drug Administration (FDA). Furthermore, the new obligations outline the responsibility that medical device manufacturers have regarding the efficacy of its product throughout the entire lifecycle, rather than focusing on the pre-approval stage. This change is critical for improving the quality of life as well as providing better protection for patients in the target market’s population.
The European market is made up of 27 countries, not including the United Kingdom, as well as additional regions that fall under the European Economic Area (EEA). Projected to be approximately 30% of the entire population by 2050, older people in the EU comprise a large part of the diverse market. With such a large and aging population, which have a greater dependency on medical devices and faces greater risks in cases of adverse events, the need for medical device manufacturers to monitor their products throughout the entire lifecycle is crucial in ensuring the safety and efficacy of the products. The MDR introduces new means to track medical device products, through the Unique Device Identification (UDI), device identifier (DI), and production identifier (PI) to increase medical device traceability. In addition, the introduction to new database systems, for example EUDAMED, for monitoring product functionality post-market, registering devices, and clinical investigations will function to enable medical device companies, regulatory bodies, consumers, and other stakeholders’ access to the most recent data on the medical device sales in Europe.
The implementation of the new EU MDR demonstrates an ever-changing regulatory landscape in the face of both technological innovation as well as changes in population demographics. For such a diverse region, with 24 official languages, the need for translation not only for regulatory submission documents, but also for technical safety documentation under the new MDR to receive CE marking, an official marking that shows compliance with standards regarding safety, health, and environmental protection, is crucial for gaining market access in the EEA. Just as the requirements for medical device manufacturers have changed and become more rigorous with the new MDR, so has the demands for translations of relevant documents. Previously, technical documents that require CE marking in the past did not require translations pre-approval. Under the new MDR, however, documents that receive CE markings like instructions for use (IFUs) and patient information documents must be translated into all 24 required languages to gain regulatory compliance. Accurate translation that is “clear and precise” is necessary across all official languages and is essential in ensuring that regardless who is reading the material, it is understood entirely and effectively. In addition, the EUDAMED database that all medical data is uploaded to, must be translated into the 24 official languages so it can be exchanged with all relevant stakeholders.
Language service providers (LSPs) can help medical device manufacturers effectively market in accordance with the new MDR, however it’s important that they choose the right partner. Qualified LSPs should have a methodology that is certified with ISO 13485:2016 and maintain a strong understanding of the MDR for the ability to address any potential regulatory compliance issues or requirements. Further, global medical device companies will also need to train staff on the new MDR compliance, meaning effective translation of eLearning materials is crucial in improving workflow as well as maintaining QMS.
The MDR brings much needed change to the EU medical device market. While the new regulation presents some uncertainty for medical device manufacturers, with proper preparation, action, and help from LSPs, these companies can be well-positioned to not only gain regulatory compliance, but also maintain success and be well-equipped for any further changes.