Decoding the PEP Step by Step
As we all know, to place an In Vitro Diagnostic (IVD) device in the European Union (EU) market, manufacturers must abide by the EU IVD Regulations (EU IVDR) 2017/746. One of the key requirements of the IVDR cycle is performance evaluation. The objective of performance evaluation is to demonstrate that the IVD is safe and effective to use, and at the same time, it is aligned with its intended use. The performance evaluation of in the IVD begins with the devising of a Performance Evaluation Plan (PEP).
Exploring the CEP – More than Just a Document!
Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography. The objective behind clinical evaluation of medical devices is to ensure patient/user safety, drive manufacturers and Notified Bodies (NBs) towards evidence-based decision-making, and at the same time inform them about Post-marketing Surveillance (PMS) activities.
Significance of the Medical Device Test License in India
In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO),. is a license which allows the manufacturer to manufacture or import small quantity of medical device for the purpose of clinical investigations, tests, evaluations, demonstrations, or training and to gather data on its safety and efficacy. The CDSCO requires the manufacturer to obtain this license to ensure that the device is safe and effective for patients’ use.
Navigating US FDA Regulations for Medical Device E-labeling
Electronic Labeling (e-labeling) is a medical device labeling alternative to traditional paper labeling. It entails the use of electronic media such as CD-ROMs, DVDs, or websites to provide consumers/users with label information. There are numerous benefits of e-labeling in the medical device industry. The most significant advantages are the following:
How Can a Medical Device Manufacturer Obtain a Loan License in India?
What is Loan License for a Medical Device?
A loan license is issued by the State Licensing Authority (SLA)/Central Licensing Authority (CLA) for manufacturing medical devices; it is an agreement between two manufacturers who grant the right to use their facilities and infrastructure for manufacturing the device. A company that wants to manufacture and market its medical device in India but does not have the necessary manufacturing capabilities for production should meet the Regulatory standards laid out by the Central Drugs Standard Control Organization (CDSCO).
A Step-by-step Installation Guide for Medical Devices
An installation guide is a type of technical document that the device manufacturer provides during medical equipment installation. It contains instructions on how to install software, hardware, or any other components that need to be assembled. An installation guide for a blood pressure monitoring device, for instance, can show users how to assemble the parts, whereas an installation guide for a pacemaker device can show users how to set it up.
The Role of Quality Management System (QMS) in the Design and Development Stage of Medical Device Lifecycle
Quality Management System (QMS) is an essential component of the medical device industry, ensuring the safety, efficacy, and Regulatory compliance of medical devices throughout their lifecycle. QMS is implemented across all stages of the medical device lifecycle, including the design and development phase, to ensure that the device meets Regulatory and user requirements, and that any potential risks are identified and addressed.
Revisiting the EU MDR Timeline Extension
The European Union's (EU) Medical Device Regulation (MDR) has been making news for a while now. The MDR has replaced the Medical Device Directive (MDD) and Active Implantable Device Directive (AIMDD). Initially, the entire transition was set out to be in complete effect by May 2020; however, due to the emergence of the COVID-19 pandemic, the implementation was pushed further to May 26, 2021. In this timeline, by May 26, 2024, all the MDD certificates will become void, and the device manufacturers will be required to conform with the EU MDR.
Classification of In Vitro Diagnostic Devices (IVDs) in China
IVD devices are essential for healthcare professionals in providing accurate and timely diagnosis, monitoring, and treatment of diseases, leading to improved patient outcomes and better public health. IVD devices are classified into different classes based on their level of risk to the patient and the complexity of the device. The classification system for IVD devices varies depending on the region or country.