NCC R&D | NCC Medical (Shanghai) Passes CE MDR On-Site Audit, Advancing into the EU Market with High-End Electrophysiology Equipment

April 21, 2026, Shanghai — NCC Medical  (Shanghai) , located in the Shanghai Pudong International Medical Industry Park, welcomed an expert audit team from DEKRA for a CE MDR compliance on-site factory audit. This rigorous inspection by DEKRA, an internationally recognized third-party authority, marks a key step for NCC Medical in obtaining CE MDR certification. It also serves as an important milestone for the company’s products (IONM, EEG, EMG, etc.) to enter the EU and other high-end global medical markets.

As a global medical device group, NCC Group holds a Dual ISO & CE MDR certified system across its operations. In February 2026, NCC Singapore successfully completed all ISO and CE MDR system audits conducted by TÜV SÜD . Currently, NCC Shanghai is undergoing an exclusive on-site compliance audit led by DEKRA – a key distinction from TÜV that underscores our rigorous regional verification and consistent adherence to international regulatory standards.

To fully meet the CE MDR regulations for high-risk medical devices, NCC Medical has systematically restructured its entire medical device lifecycle management system over the past three years. This covers every stage from R&D to production and delivery, including core aspects like technical documentation, clinical evaluation, risk management, and production control. This ensures product safety, efficacy, and traceability, in full compliance with MDR’s general safety and performance requirements.

On-site Audit Kick-off Meeting

During the R&D phase, the company strictly adhered to EN 60601 standards and requirements, establishing a risk-based design control process. From the initial product concept to design changes, every step was reviewed, verified, and validated, ultimately resulting in a complete and traceable technical documentation package that meets DEKRA 's high standards for integrity and compliance.

Factory Inspection of Equipment

In clinical validation, the company conducted multi-center, prospective clinical evaluation studies in compliance with CE MDR regulations, systematically gathering clinical data. The product’s clinical benefit-risk ratio performed excellently, providing solid evidence for CE certification.

The company has fully implemented a quality management system in line with ISO 13485:2016 and EU GMP requirements. NCC Medical has established a clean room production facility, conducting multi-stage inspections on incoming materials, semi-finished products, and finished goods. Throughout the production process, stringent process validation and continuous monitoring ensure that each device is stable, reliable, and meets TDEKRA 's production consistency and process control audit standards.

Factory Inspection of Equipment before Dispatch

To address interference challenges in the complex electromagnetic environment of operating rooms, NCC Medical set up a high-standard electromagnetic compatibility (EMC) lab. The lab simulates scenarios with multiple strong interference sources (e.g., high-frequency electrosurgical devices and patient monitors), testing the products’ immunity to disturbances. The R&D team has continuously optimized shielding structures, filtering circuits, and differential amplification algorithms to ensure stable microvolt-level neuro-signals even under extreme interference conditions.

Neuroelectrophysiological Electromagnetic Shielding & Interference Test System

“This DEKRA CE MDR factory audit is not only a comprehensive inspection of our existing systems, but also an important opportunity to drive our company toward globalization, standardization, and lean management,” said NCC Medical's overseas department manager “We look forward to accelerating the CE MDR certification process, bringing Chinese-developed high-end electrophysiology devices to broader international markets, and providing safer, smarter neuro-monitoring solutions for global patients and clinicians.”

The successful DEKRA CE MDR certification further strengthens NCC Medical’s compliance capabilities in the high-end electrophysiology and intraoperative neuro-monitoring fields, continuing to provide safe, reliable, and internationally compliant medical devices to healthcare institutions worldwide.