For medical environments to remain safe and effective, sterilization of equipment and devices is essential. This procedure gets rid of all microbiological life, such as spores, fungi, viruses, and bacteria. Doing so is crucial to stopping the spread of illness, particularly during operations where sterile bodily fluids or tissues are involved. Sterilization lowers the possibility […]
Introductory Remarks Continuing our examination of the MDR/IVDR transition period, we delve into the transition period’s subtler points. In this section, we examine the conditions manufacturers must meet in order to benefit from the extended transition, as well as the evidence required to support this procedure. In addition, we explicate the nuances of transitioning surveillance […]
Regulatory criteria are tightening as the field of medical devices continues to develop. Technological developments have produced smaller, more intricate devices that frequently make use of cutting-edge plastics. Processes for validation and verification (V&V) have become extremely important in this situation. They not only make sure that laws are followed, but they also help to […]
The medical devices sector in Europe is experiencing rapid growth and transformation, driven by advancements in technology, developing regulations, and an aging population. In this post, we will discuss the latest trends, developments, and innovations in the European medical devices sector and their impact on the industry’s future. Challenges and opportunities in the Medical Devices […]
CEP/CER, PSUR, and PMCF are essential components of the regulatory compliance requirements for the medical device industry. These regulatory documents are essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. According to the new EU Medical Device Regulation, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are mandatory […]
The Swissmedic position paper on DCTs second version was published on 15th December 2022. The Swiss Agency prepared it for Therapeutic Products (Swissmedic). In this blog, we will discuss some of the most critical aspects of this document. Introduction What is a decentralized clinical trial? A decentralized clinical trial (DCT) is a research study in […]
The EU MDR is a new addition to an already existing set of medical device regulations. Medical device manufacturers looking forward to implementing MDR must understand the changes that MDR brings with it. Moreover, they must also understand the critical differences between EU MDR and the US FDA, another renowned regulatory framework. Differences between FDA […]
The coronavirus COVID-19 has seized the global economy. The major economic players have gone down due to the outbreak. Every industry is being affected. Similarly, the medical devices sector is no exception in this regard. Although the medical device industry had a standing for being more resilient and recession-proof than other industries because in many […]
MEDDEV 2.7.1 Rev 4 – Demystifying the new requirements MEDDEV 2.7/1 is a guiding document for clinical evaluation of medical devices and it is titled as “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC”. MEDDEV 2.7/1 revision 04 (guideline for clinical evaluations) is available for guidance since 1st July 2016. […]