In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in mind, in order to (re-)establish confidence in regulatory processes, authorities are demanding greater patient protection. This has led to increased [...]
In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device Regulation (MDR, 2017/745). Unlike the MDD, the MDR considers clinical evaluation to take place during the full lifecycle of medical devices, meaning clinical data must be updated continuously. Seeing as clinical data is usually sourced from clinical investigations, post-market [...]
Overview The EU MDR and IVDR will usher in increased post-market surveillance (PMS) requirements for all MedTech companies. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary. Higher-risk devices and IVDs will require a Periodic Safety Update Report (PSUR). While for lower-class devices, a [...]
Introduction to Software as a Medical Device in MDR The MDCG’s Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR. This doc even seeks to elucidate which software will be considered a medical device (qualification) and its subsequent risk classification (classification). Although it is not [...]
INTRODUCTION A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, including drawing information for making evidence-based reports, academic assessment, and a step in the research methods. A thorough literature search [...]
With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance on regulating medical devices. Given the current circumstances, the Brexit transition period will end without a trade deal in place [...]
What the Medicines and Healthcare products Regulatory Agency does MHRA is an executive agency in the Department of Health and Social Care. The Medicine and Healthcare products Regulatory Agency regulates medicines and devices for transfusion in the UK. MHRA regulates medicines, medical devices, and blood components. Following the UK Medicines and Healthcare products Regulatory [...]
What is a clinical evaluation report? Clinical Evaluation Reports are a must for all medical devices in Europe. They must submit your CER to your Notified Body as an attachment to your European CE Technical File. The Technical File is an essential step to obtaining CE Marking for your device, which is necessary to [...]
Medical device regulations in China are often similar to the European Union (EU)’s MDR. With a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). Although both the forgoing regulatory frameworks permit equivalent devices as a basis for clinical data for a new device, the [...]
Medical Device Software (MDSW) The MDSW is defined as a Medical Device regardless of its location of use. Software that is driving or influencing the use of a medical device can qualify as a device. Software intentionally to process, analyze, create or modify medical information will be considered medical device software if it has [...]
