IVDR FAQ and Best Practices for The Vigilance of In Vitro Diagnostic Medical Devices

By |2022-11-10T22:46:47+00:00November 15th, 2022|

The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, and other users by reducing the probability of reoccurring serious incidents related to in vitro diagnostic medical devices. For that to happen, EU member states and their national competent authorities must be aware of any serious incidents and actions are [...]

Market Surveillance of Medical Devices Under the EU MDR

By |2022-11-08T18:56:40+00:00November 8th, 2022|

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures in place to verify and guarantee the regulatory compliance of products and to establish processes and appropriate measures for diminishing [...]

The Post-Market Surveillance Document: Which Ones Do you Need?

By |2022-11-01T16:35:05+00:00November 1st, 2022|

It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, including devices that have been incorporated or are intended to be incorporated into a medical device system (i.e., active implantable [...]

Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices

By |2022-10-31T09:02:29+00:00October 25th, 2022|

In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force. The regulation forms the core of European market surveillance law and will grant market surveillance authorities additional powers and strengthen the exchange of information between competent authorities. Furthermore, it seeks to uniformly [...]

In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings

By |2022-10-28T16:25:28+00:00October 18th, 2022|

CE marking indicates compliance with an EU directive so that you can market your products in the EU.   It's that simple.   CE marking is a voluntary conformity assessment procedure, but it is a requirement if you plan to market your product on the European market.   The letters "CE" stands for Conformité Européenne [...]

Medical Device Reporting (MDR): How to Report Problems to the FDA

By |2022-10-28T16:25:54+00:00October 11th, 2022|

Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen. Off-label use, installation/service issues, lack of training, and many other causes can lead to suspected medical device-associated deaths, serious injuries, and malfunctions.   Every year, the Food and Drug Administration (FDA) receives hundreds [...]

Post-Market Surveillance Process and What It Will Cost You

By |2022-10-28T16:26:02+00:00October 4th, 2022|

Post-market surveillance and vigilance costs are overgrowing. For example, the number of reported adverse reactions has increased annually by approximately 10-15% over the past five years. In addition, costs for post-market surveillance have been growing, especially in high-risk products.   What is PMS or post-market surveillance? In post-market surveillance, a drug or medical device is [...]

Five Practical Tips For Clinical Literature Review

By |2022-10-28T16:26:16+00:00September 27th, 2022|

The European Medical Device Regulation (MDR) outlines the requirements for the literature review needed for the clinical evaluation of medical devices. You need a robust process for performing your literature review and finding clinical data to evaluate your device's safety, benefit, and risk in an evidence-based manner.   Since the medical device literature reviews [...]

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