7 things a performance evaluation must consist of
Under the IVDR Regulation (EU) 2017/746 (IVDR), all IVDs must undergo a Performance Evaluation before being placed on the market. The Performance Evaluation is an important aspect of the IVDR, as it ensures that IVDs are safe, accurate, and effective for their intended use. The requirements on carrying out a performance evaluation plan and report […]
European Regulations for Companion Diagnostics (CDx): Navigating the CE Marking Pathway to Market
Companion diagnostics (CDx) play a big role in personalised medicine and are increasingly vital in modern medicine. In accordance with the European Union In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), CDx devices must undergo conformity assessment by a notified body to obtain CE marking for entry into the EU market. It’s advisable for […]
Step-by-Step Process: How to Conduct a Performance Evaluation for your In Vitro Diagnostic Device
What is Performance evaluation and why is it important? Under the IVDR Regulation (EU) 2017/746 (IVDR), all IVDs must undergo a Performance Evaluation before being placed on the market. The Performance Evaluation is a continuous process conducted throughout the lifecycle of an IVD, that assesses the Analytical and Clinical Performance, Scientific Validity which forms the […]
Medical Device Regulatory Intelligence – What is Required?
With regulatory requirements ever evolving and the stringency of medical device regulation, it is no wonder that the complexities are confusing when it comes to regulatory compliance. But what do you understand when it comes to Regulatory Intelligence (RI)? For lower risk devices such as class I non-sterile, the RI should be pretty straight forward […]
ISO 13485 Quality Management System Implementation: A Guide to Creating a Quality Manual
ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) for organisations involved in the design, development, production, installation, servicing, sales, and distribution of medical devices (including in vitro diagnostics). Clause 4.2.2 of the standard requires the organisation to document a quality manual. You may be wondering what a quality manual […]
The Most Common Problems in Creating Technical Documentation for your Medical Device
Navigating the intricacies of EU/UK medical device regulations in preparation for the creation of technical documentation that is necessary for market entry, can prove challenging; and it can also be incredibly difficult to understand the requirements to streamline the reviewal process. As if the requirements aren’t complex enough, we need to be prepared for the increased scrutiny […]
