Evolving regulations for medical devices and in vitro diagnostics continue to bring challenges across the US and European markets. Our experts address these challenges across both jurisdictions, increasing the predictability of your strategies and development activities.
NDA’s experts will get your product to market on time
Medical devices are facing an increasingly complex regulatory environment. To get a product approved in Europe and the US a manufacturer has to take markedly different regulatory approaches into account. If the product is a combination of medicine and device the difficulties of interpreting the regulatory requirements increase even further.
The NDA Medical Device Division addresses the regulatory challenges inherent in the US system, as well as those in the new EU Medical Device and In-Vitro Diagnostics Regulations in an integrated way, ensuring you can rely on our experts across both jurisdictions.
Advances in medical technologies call for evolving regulatory requirements
As delivery system technology and medical devices continue to develop, the combination of drug-device and device-drug modalities are rapidly increasing and the distinction between the modalities is becoming blurred. In some situations, it is difficult to discern the application type of the final product and its associated risk profile. Our expertise covers all types of combination products, whether they are regulated as a medicine or as a medical device.
The technological advances in combination with incompatible regulatory systems in Europe and US are making the correct classification of combination products increasingly challenging. When partnering with NDA, our medical device experts can assist you in this process to optimize your chances for a timely market entry. Once a device classification is secured, we ensure professional management of the device component as well as constructive interactions with the EU Notified Bodies and UK Approved Bodies.
They wouldn't be called hurdles if they couldn't be overcome
The increased stratification of patients to optimize the efficacy of medical treatments is enabled by sophisticated in-vitro diagnostics, sometimes down to the genome level. For many companies, IVDs are essential to move their medicine to market and they are faced with challenges to understand how to navigate the regulatory landscape associated with these devices. NDA helps clarify the regulation and ensure that your diagnostic can be developed with a clear path to the market in mind.
The increased requirements on the Quality Management process have raised the bar for most device manufacturers. Ensuring that your Quality Management System is in line with the relevant regulation is not just a matter of compliance – without it you may not be allowed to sell your products. When partnering with NDA, our experts will take the headaches out of your product launch and ensure you have streamlined systems in place to manage your product on the market.
Medical Device Experts
Professor Dr Mira Pavlovic-Ganascia, MD
Medical devices and their growing regulatory challenges
New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics
NDA Webinar: MDR Session 1 an introduction to the key changes in the new EU MDR
NDA Webinar: MDR Session 2 Quality Management System update to meet MDR requirements
NDA Webinar: MDR Session 3 Impact of EU MDR 2017/745 on Drug/Device Combination Products (DDCs)
NDA Webinar: MDR Session 4 Clinical Evaluation of Medical Devices according to MDR
NDA Webinar: MDR Session 5 Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) requirements under the EU Medical Device Regulation.
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
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