CE certification process under Regulation (EU) 2017/745 is comprehensive and rigorous, aiming to ensure that medical devices placed on the EU market meet high standards of safety, performance, and quality while protecting patient health and safety. Compliance with the MDR is essential for manufacturers seeking to market their medical devices in the European Union.
The CE certification process according to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), is a mandatory conformity assessment procedure for medical devices placed on the European Union (EU) market. The MDR replaced the previous Medical Devices Directive (MDD) and aims to enhance the safety and performance of medical devices while ensuring a high level of protection for patient health and safety. Here's an overview of the CE certification process under Regulation (EU) 2017/745:
Classification of Medical Devices
The first step in the CE certification process is determining the classification of the medical device according to its intended use, potential risks, and duration of contact with the human body. Medical devices are classified into Classes I, IIa, IIb, and III, with increasing regulatory requirements based on the level of risk.
Conformity Assessment Procedure
Depending on the classification of the medical device, manufacturers must select the appropriate conformity assessment procedure to demonstrate compliance with the requirements of the MDR. These procedures may include:
Self-assessment for low-risk devices (Class I) with no involvement of a notified body.
Involvement of a notified body for medium to high-risk devices (Classes IIa, IIb, and III), which may include assessment of technical documentation, design examination, quality system auditing, and product testing.
Technical Documentation
Manufacturers are required to prepare technical documentation demonstrating conformity of the medical device with the applicable requirements of the MDR. This documentation should include information such as device description, design and manufacturing information, risk assessment, clinical evaluation, labelling, and instructions for use.
Quality Management System
Manufacturers must establish and maintain a quality management system (QMS) in accordance with the requirements of the MDR. The QMS should ensure the effective design, manufacture, and distribution of medical devices and compliance with regulatory requirements.
Notified Body Involvement
For devices requiring the involvement of a notified body, manufacturers must select a notified body accredited by an EU member state. The notified body assesses the manufacturer's technical documentation, conducts audits of the manufacturer's quality management system, and may perform product testing or inspection as necessary.
Declaration of Conformity and CE Marking
Once conformity with the MDR has been demonstrated, the manufacturer or authorized representative issues a Declaration of Conformity stating that the device meets the requirements of Regulation (EU) 2017/745. The CE marking is affixed to the device, indicating compliance with applicable EU regulations.
Post-market Surveillance
Manufacturers are required to establish post-market surveillance systems to monitor the performance and safety of their medical devices once they are placed on the market. This includes monitoring feedback from users, reporting adverse events, and taking appropriate corrective and preventive actions as necessary.
Periodic Safety Update Reports (PSURs)
Manufacturers of certain high-risk devices are required to submit periodic safety update reports to competent authorities, providing information on the safety and performance of their devices and any actions taken to address safety concerns.
PRNS would serve CE mark certification services of Medical Devices, IVDs and other directive and regulations through Collaboration/Partnership Agreement with a European Notified Body.
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