Over the course of the year we have been highlighting some of the 100 most read articles on the Acorn Regulatory website. Again, we are featuring another 10 of the top 100 most widely read articles.
You can click on the headline to read the article in full or you can click here to read and see the full list of the top 100 articles on our website.
With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly common. Indeed, many questions have been raised about borderline medical devices. In such cases, the intended purpose of the app and the medical benefit to a patient must be carefully reviewed in making the classification decision.This document lists decisions and rationale on medical device classification of borderline cases where there is difficulty in interpreting the rules, and serves as a useful tool in understanding the interpretation of medical device classification rules.
2. Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance
Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on the market they still have to meet certain obligations. Implementation of a system for post-market surveillance is a requirement for all classes of IVDs and medical devices, but what is post market surveillance, and what does this mean in practice?
Post-market surveillance is the collection of information on quality, safety and performance of medical devices after they have been placed on the market. It provides on-going feedback to help maintain quality, device safety and customer satisfaction. As product risks can never be completely eliminated, manufacturers need to continually monitor feedback through post-market surveillance to ensure risk is maintained at an acceptable level.
Our quality team has a well deserved reputation for excellence. In this blog they share their thoughts on what you need to do when conducting internal audits at your facility.
If you are a manufacturer of an IVD or a medical device, once your product is on the market, you must have an effective system for reviewing and evaluating customer complaints and product issues for any safety concerns. The European Commission guidance MEDDEV 2.12/1 revision 81 should be your first port of call in guiding you on making the determination that an event constitutes a reportable incident. In the first of a two part series on medical device vigilance I’m presenting the Cheat’s Guide to the European vigilance system.
In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD and medical device manufacturers. In this article, we are going to delve a bit deeper and answer some questions about vigilance reporting that we are regularly asked by clients.
There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians – everything from medication reminders to apps which calculate drug dosage. In this brief overview we look at CE Marking an App.
7. Medical Device Post-Market Obligations, a European Perspective: Part 2 – Assessing Product Changes
In the first part of this series, we outlined the post-market obligations for Manufacturers under the European IVD and medical device directives. In the second part of this series we are going to discuss another post-market topic – change control.
CE Marking a medical device and placing it on the market in the EU requires a number of steps need to be taken. In this blog article we look at the steps and the questions that you need to ask.
Good Pharmacovigilance Practice (GVP) at its core aims to prevent harm from adverse reactions in humans from medicines and to promote the safe and effective use of medicinal products. Pharmacovigilance professionals are aware that adverse reactions can be reported from a variety of sources – patients, healthcare professionals, competent authorities or marketing authorisation holders.
In this blog we look at the Periodic Safety Update Single Assessment or PSUSA.
The World Health Organisation defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Due to limits of clinical trials, continuing to collect information on a medicine following authorisation is an important way to monitor the safety of medicines.
We will look back at further articles in the Top 100 as 2018 goes on. Don’t forget that you can look at the entire list here. If there is a topic that you would like to see covered then please let us know by completing the form below.