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

By |2022-12-15T13:11:20+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 |2022-12-15T13:11:20+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 |2022-12-15T13:11:21+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 |2022-12-15T13:11:21+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 |2022-12-15T13:11:22+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 [...]

Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?

By |2022-12-15T13:11:23+00:00August 30th, 2022|

Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity from the two other surveillance activities? Don't fret! Today, we are exploring post-market surveillance, market surveillance, and vigilance and telling [...]

10 Tips about Feedback from Clients and Users for Medical Device Manufacturers

By |2022-10-28T16:28:28+00:00August 23rd, 2022|

Feedback is important. No matter what you're selling, if you want to improve, it's crucial to know what customers think of your product and how they feel about the experience they have with it.   Medical devices' feedback can be precious because they're often life-saving. In addition, you want to ensure that you're providing [...]

Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)

By |2022-10-28T16:28:36+00:00August 16th, 2022|

Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies. A clinical evaluation report (CER) that was compliant ten years ago might not pass conformity assessment today, even though clinical evaluation [...]

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