CE marking originally refers to conformity marking required by law for medical devices and in vitro diagnostic devices (IVDs) in the European Union. This demonstrates conformity with EU safety, health and environmental requirements. The MDR 2017/745 and the IVDR 2017/746 lay out the ground rules for CE marking in both the medical and in vitro diagnostic device sectors.
Regulation MDR 2017/745 and Regulation IVDR 2017/746
MDR 2017/745 and IVDR 2017/746 have superseded the prior directives (93/42/EEC, 90/385/EEC, 98/79/EC) by imposing stricter rules aimed at improving the quality and safety of medical devices and IVDs. The MDR for general medical devices and the IVDR for in vitro diagnostic devices; are personified in tightening firmly in the noose of clinical evaluation and post-market surveillance; in enhancing transparency through a structure, such as the European database on medical devices (EUDAMED); and in operationalizing the technical documentation requirements.
Need For Technical Documentation
The heart of the MDR and IVDR is technical documentation which demonstrates that a device meets the regulatory requirements. In the case of MDR, the technical documentation covers the information on the design, production, properties and intended purpose of the devices, clinical evaluation reports, risk management files and conformity assessment procedures. Similarly, IVDR technical documentation should touch on analytical performance, clinical performance studies, risk management and post-market performance follow-up plans.
Sterilization Validation
Sterilization validation: Medical devices that should be sterile must be demonstrated to be free from viable microorganisms. The process includes the selection of an appropriate sterilization method (steam, ethylene oxide, gamma radiation), sterilization processing development, and the validation of this supply with microbiological and chemical testing. When validating, it must be considered that the sterilisation process must demonstrate with BIs put in the most difficult places in the most difficult unit that the required sterility assurance level (SAL) is reached and therefore that the patient will be safe.
Clean Room Validation
Clean rooms r the controlled environments for the manufacturing of sterile medical devices, here concentration of airborne particles is controlled. This is followed by tests to ensure that the room meets the standards (ISO 14644). This will involve testing for particulate and microbial contamination, air pressure differentials, and temperature and humidity control. Monitoring should be part of an ongoing process that includes re-validation at Supplier C to ensure compliance with regulatory requirements and the quality of the devices produced.
General safety and performance requirements (GSPR)
MDR and IVDR require that general safety and performance requirements (GSPR) be fulfilled by medical devices and IVDs on post Execute These requirements include biocompatibility, chemical, physical and biological characteristics, infection and microbial contamination, and performance of device over the course of normal use. GSPR validation: The manufacturer must prove compliance with GSPR through very accurate tests and justify everything (documentation).
Usability
Throughout the design and development of medical devices, usability is a very important aspect to ensure that the devices can be used safely and effectively by the intended users in the expected use environment(s). This includes assessing for example the device design, the user interface, the device labelling and instructions for use to reduce user errors and improve the experience. Despite the difficulty of validating usability, it is a risk management activity and helps to ensure the safe and effective performance of the device.
Shelf Life and Lifetime
Life shelf duration means the duration a device complies with specifications if stored by given requirements. Shelf life is established through stability testing to ensure the sterility, packaging integrity, and performance of the device over time. Manufacturers are required to provide evidence that supports the shelf life claimed in the technical documentation.
That is just the Utilization Life and not the Medical Device Life, which signifies the amount of time that the device is expected to function when operated according to manufacturer guidelines. This includes sturdiness testing according to put on & tear, fatigue, and ageing. Knowledge of the lifespan of any device is important for guaranteeing performance and safety in the long term.
Conclusion
CE marking for medical devices under MDR 2017/745 and IVDR 2017/746 carries with it considerable regulatory requirements that are designed to provide a high degree of certainty that the devices are safe and perform as intended. Manufacturers must follow strict standards from elaborate technical documentation to meticulous validating processes regarding sterilization, clean rooms, usability and shelf life. This ensures that the devices remain safe and effective at a minimum throughout the claimed shelf life and, if applicable, lifetime. By meeting these stringent requirements, manufacturers can obtain CE marking, which enables them to enter the European market and helps to enhance patient safety across the European Union. Contact the I3CGLOBAL consulting team for more details.