The MDR (European Medical Device Regulation) is a comprehensive set of current legal rules that all medical devices intended for sale on the European Union market must comply with. It directly binds all manufacturers, importers, and distributors in the sector.
PMCF is a systematic data collection activity conducted to monitor the safety and performance of a commercially available medical device under real-world conditions of use. PMCF studies contribute to the continuous evaluation of the benefit-risk balance of the device and are an important part of the MDR requirements.
Yes. In addition to documentation and system setup, we also provide technical guidance throughout all stages of the official audits conducted by the certification body.
The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.
The technical file includes documents such as product description, design information, risk management, verification and validation studies, test reports, clinical evaluation, usage instructions, labeling, and manufacturing information.
For medical device manufacturers, this document is a fundamental corporate requirement for complying with legal regulations (MDRs), primarily CE certification, and for confidently entering global markets.
Medical device clinical trials are any systematic studies involving one or more volunteers conducted to evaluate the safety or performance of a device.
Clinical trials are conducted for all medical devices, whether or not they have received the CE mark. These trials are divided into two categories: academic and commercial. Clinical trials can be conducted retrospectively or prospectively.
The technical file is the most fundamental document proving the safety and performance of your device. This file, which will be reviewed by approved organizations and the ministry, must be complete and directly determine your product's market approval.
The CE certification process typically involves the following steps:
Medical device classification is determined according to its intended use, place of use, risk level, invasiveness, duration of effect, and level of interaction with the body;
Accurate classification is crucial for documentation purposes, therefore professional assistance is recommended.
Medical device regulations are constantly being updated. As ERA Management, we closely monitor these global and national regulatory changes on behalf of your company, keeping your system up-to-date without interruption.
