Neurological device testing and certification

Neurological medical devices are designed to interfere with the human nervous system to diagnose, monitor or treat a broad spectrum of medical conditions. The neurological devices can be divided in three main categories:

• Neuromodulation devices, which alter the neural signals using electrical, magnetic or chemical means to treat medical conditions or relieve symptoms. This category includes implantable neurostimulators used for pain and movement symptoms relief, modern bioelectronics devices, used for treatment of chronic conditions and external stimulation devices, as transcranial magnetic stimulation or electric stimulation.
• Brain Computer Interface and brain activity monitoring devices, as electro encephalography system (EEG)
• Neurovascular and interventional devices, stents, ventricular catheters or hydrocephalus shunts.

Beyond traditional devices such as shunts, stents, catheters, and active neuromodulation devices, neurological device technology is evolving rapidly to treat new indications. These include innovative bioelectronics devices, closed-loop systems, and brain computer interface devices. They promise to treat an expanded range of psychiatric and neurodegenerative diseases to deliver even more benefits to patients.

Given this fast-changing landscape, it is necessary for testing and certification to keep up.

 Neurological medical devices continue to enjoy rapid growth and are expected to do so in the coming years. New treatments and therapies are constantly emerging. The need to ensure safe and reliable use of these devices becomes paramount.

Complex and sometimes unclear regulations have emerged in response to the changes in technology. These regulations vary across markets, with different tests often required to comply with market-specific requirements. A further layer of complexity is that the patient population benefiting from these treatments can be huge in some cases and limited in others.

With this wide range of factors affecting device safety and compliance, it is difficult to build the relevant expertise in-house. Partnering with TÜV SÜD will assure you that a trusted third-party assesses all aspects of product safety and regulatory compliance.

TÜV SÜD is a certified organisation that offers testing services in accordance with international standards. We verify various aspects crucial to neurological devices, such as biocompatibility, electrical safety, and cybersecurity.

As a European notified body, TÜV SÜD offers conformity assessment in accordance with Medical Device Regulation, required for marketd approval. Our assessment team of interdisciplinary experts includes neurosurgeons and engineers with experience in neuromodulation devices, EEG and imaging systems, medical software, AI, and cybersecurity.

With comprehensive services and a global presence, we serve as a single point of contact for all your testing and certification needs. Our specialists and network of test laboratories provide a complete range of services, including innovative neurological devices.

TÜV SÜD’s neurotechnology conformity assessments include:

• Technical documentation review and clinical reviews – During the certification process, TÜV SÜD Notified Body assess the technical documentation of neurological devices for compliance with Medical Device Regulation. TÜV SÜD Clinical Centre of Excellence specialises in clinical reviews. Our experts involved in the reviews include neurosurgeons, engineers, biocompatibility and sterility scientists, and clinicians trained in medical device regulations. They possess vast neurotechnology experience gained from their many years in industry.
• Quality management system auditing – TÜV SÜD Notified Body performs a quality management system audit consistent with MDR requirements. Once we complete a positive assessment, we will issue a Quality Management System certificate.  In addition, we offer the possibility of certification in accordance with the Medical Device Single Audit Program (MDSAP) to enable achieving global market access in a wide variety of regions.
• Testing services – TÜV SÜD testing labs offers a wide range of neurological device testing services including biocompatibility, chemical characterisation, electrical safety, electromagnetic compatibility, cybersecurity, MRI safety, sterilisation, and packaging.

TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD’s designated Notified Body and related Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs.