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CE certification process under Regulation (EU) 2017/746 is comprehensive and rigorous, aiming to ensure that in vitro diagnostic medical devices placed on the EU market meet high standards of safety, performance, and reliability while protecting patient health and safety. Compliance with the IVDR is essential for manufacturers seeking to market their IVDs in the European Union.
The CE certification process according to Regulation (EU) 2017/746, also known as the In Vitro Diagnostic Medical Devices Regulation (IVDR), is a mandatory conformity assessment procedure for in vitro diagnostic medical devices (IVDs) placed on the European Union (EU) market. The IVDR replaced the previous In Vitro Diagnostic Medical Devices Directive (IVDD) and aims to enhance the safety, performance, and reliability of IVDs while ensuring a high level of protection for patient health and safety. Here's an overview of the CE certification process under Regulation (EU) 2017/746:
Classification of In Vitro Diagnostic Medical Devices
The first step in the CE certification process is determining the classification of the IVD according to its intended use, intended purpose, and potential risks to patients and users. IVDs are classified into Classes A, B, C, and D, with increasing regulatory requirements based on the level of risk.
Conformity Assessment Procedure
Manufacturers of IVDs must select the appropriate conformity assessment procedure based on the classification of the device. These procedures may include:
Self-assessment for low-risk devices (Class A) with no involvement of a notified body.
Involvement of a notified body for medium to high-risk devices (Classes B, C, and D), which may include assessment of technical documentation, performance evaluation, quality management system auditing, and product testing.
Technical Documentation
Manufacturers are required to prepare technical documentation demonstrating conformity of the IVD with the applicable requirements of the IVDR. This documentation should include information such as device description, intended use, performance evaluation, analytical and clinical performance data, 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 IVDR. The QMS should ensure the effective design, manufacture, and distribution of IVDs 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 IVDR has been demonstrated, the manufacturer or authorized representative issues a Declaration of Conformity stating that the device meets the requirements of Regulation (EU) 2017/746. 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 IVDs 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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