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Siemens Xcelerator Software Automatically Identifies Vulnerable Production Assets in New Release

Siemens, a global leader in industrial automation and digitalization, has recently announced the release of its new Xcelerator software that...

Siemens, a global leader in technology and innovation, has recently introduced a groundbreaking new feature in its Xcelerator software that...

Paytient, a leading healthcare technology company, has recently announced the appointment of Joe Gabler as their new Chief Growth Officer....

Seek Labs, a leading biotechnology company, has recently announced the successful completion of an in vivo trial for African Swine...

As technology continues to advance at a rapid pace, the healthcare industry is constantly looking for ways to improve patient...

In the ever-evolving world of medical technology, advancements in artificial intelligence (AI) have revolutionized the way healthcare professionals diagnose and...

Artificial Intelligence (AI) has revolutionized many industries, and the field of medical devices is no exception. One area where AI...

Technology transfer in the field of medical devices is a crucial process that involves the transfer of knowledge, technology, and...

Technology transfer in the field of medical devices is a crucial process that involves the transfer of knowledge, skills, and...

Technology transfer in the field of medical devices plays a crucial role in bringing innovative products to market and improving...

Technology transfer in the field of medical devices plays a crucial role in bringing innovative products to market, improving patient...

In vitro diagnostic (IVD) manufacturers play a crucial role in the healthcare industry by providing essential tools for diagnosing and...

Medical device reporting (MDR) is a crucial aspect of ensuring the safety and effectiveness of medical devices on the market....

Intuity Medical, a leading medical technology company, has recently announced that its POGO Automatic® Blood Glucose Monitor is now covered...

Facelifts have been a popular cosmetic procedure for decades, with the goal of rejuvenating the face and reducing the signs...

Shimadzu Corporation, a leading manufacturer of analytical and measuring instruments, has recently been awarded a grant for their innovative vacuum...

Ivantis, a leading medical device company, has recently received positive feedback on its Hydrus Microstent in a report released by...

The Central Drugs Standard Control Organization (CDSCO) in India has recently announced a significant update regarding the registration and licensing...

Uzbekistan is a country with a growing healthcare sector and an increasing demand for medical devices. However, navigating the regulatory...

Hyalex Orthopaedics, a leading medical device company focused on developing advanced polymers for use in orthopedic surgeries, has recently announced...

A Quality Management System (QMS) is a crucial component for any organization looking to improve their processes, increase efficiency, and...

Performance evaluation is a crucial step in the development and validation of in vitro diagnostic (IVD) devices. It ensures that...

BD, a global medical technology company, has recently announced its expansion of access to advanced image-enabled, spectral cell sorters. This...

Greenlight Guru Clinical is a leading provider of quality management software for the medical technology industry. Their platform offers a...

Greenlight Guru, a leading provider of quality management software specifically designed for the medical device industry, has once again proven...

Managing budgets and meeting milestones are crucial aspects of conducting successful clinical investigations in the field of medical technology (MedTech)....

The National Medical Products Administration (NMPA) in China has been busy in April 2024, with several important updates and developments...

The Food and Drug Administration (FDA) has recently announced that it will be clearing Bluetooth medical devices for use in...

The Food and Drug Administration (FDA) has recently announced that it will be clearing the use of Bluetooth technology in...

The National Medical Products Administration (NMPA) recently issued a new guideline aimed at improving usability engineering in medical devices. This...

Updated Guidance for IVD Manufacturers on IVDR’s SSP Requirements Released by MDCG

The Medical Device Coordination Group (MDCG) has recently released updated guidance for in vitro diagnostic (IVD) manufacturers on the requirements for the In Vitro Diagnostic Regulation’s (IVDR) System and Procedure Pack (SSP). The IVDR, which came into effect in May 2017, aims to ensure the safety and performance of IVD medical devices within the European Union.

The SSP is a key component of the IVDR, as it contains all the necessary information for the proper use of an IVD medical device. It includes instructions for use, information on the intended purpose of the device, and details on how to interpret the results. The SSP is crucial for ensuring that healthcare professionals and patients can use the device safely and effectively.

The updated guidance from the MDCG provides IVD manufacturers with detailed information on what should be included in the SSP, as well as how to ensure compliance with the IVDR. This includes guidance on how to draft clear and concise instructions for use, how to provide information on the intended purpose of the device, and how to ensure that the SSP is easily accessible to users.

In addition, the guidance also provides information on how IVD manufacturers can demonstrate compliance with the IVDR’s requirements for the SSP. This includes guidance on how to conduct risk assessments, how to validate the performance of the device, and how to ensure that the SSP meets the requirements for labeling and packaging.

Overall, the updated guidance from the MDCG is a valuable resource for IVD manufacturers who are looking to ensure compliance with the IVDR’s requirements for the SSP. By following this guidance, manufacturers can ensure that their IVD medical devices are safe and effective for use within the European Union, ultimately benefiting both healthcare professionals and patients.