While placing your medical device on the European Union (EU) market, obtaining CE marking is a mandatory step. This is essential to assure the end user that the devices available in the market are both safe and effective for use. A critical component for providing this assurance involves a thorough examination of the technical documentation for the medical devices.
The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.
In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.
With the transition in the European Union (EU) geography, from the Directives to the EU Medical Devices Regulations (MDR) 2017/745, significant changes have occurred in terms of rules and regulations. One such major change was observed in Annex I – General Safety and Performance Requirements (GSPR). In our previous blog, we deep dived into Chapter I and II. In this blog, we will analyze Chapter III and learn about additional details and Essential Requirements (ERs).
The implementation of the In Vitro Diagnostic Regulation (IVDR) 2017/746 on May 26, 2022, has resulted in heightened scrutiny and Regulatory supervision for In Vitro Diagnostics (IVDs) in the European Union (EU).
Reprocessing refers to the method through which you can reuse medical devices safely and effectively. The European Union Medical Device Regulation (EU MDR) 2017/745 describes the word “reprocessing” as exclusively used for single-use devices, while it describes the reprocessing of reusable devices as “the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilization appropriate to the member state or the member states in which the device has been placed on the market. “
The European Union Medical Device Regulation (EU MDR) has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directives (AIMDD), introducing several significant changes in the regulations. One of the key elements that has been replaced is Essential Requirements (ER). ER have now been replaced by General Safety and Performance Requirements (GSPR). Although it might seem that both lay out the same requirements, GSPR lays out more stringent requirements. For instance, under GSPR, manufacturers are now required to demonstrate and analyze more clinical data.
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.
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.
With the implementation of the European Union (EU) Medical Device Regulation (MDR) 2017/745, one of the areas that caught the most attention was the new Post-Market Surveillance (PMS) system for devices. Establishing a PMS for a device has become a mandatory task for manufacturers. The objective behind this stringent requirement is to ensure device safety throughout the product’s lifecycle. Post-market Clinical Follow-up (PMCF) is part of the PMS and refers to the evaluation and collection of data for the devices placed in the market.
