2015: Good Pharmacovigilance Practice (GvP) and Social Media
Editor’s Note: This article about GvP and social media is one of the most read articles ever on our website. With that in mind, we updated it in 2019 to take into account the myriad changes that had occurred in...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
CE Marking a Medical Device
CE marking a medical device and placing it on the market in the EU requires several steps that need to be taken. In this blog article, we look at the steps and the questions that you need to ask.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsIVD DevicesMDD DevicesMDRMedical Devices
Update on the new EU In Vitro Diagnostic Medical Device Regulation: Seven Key Changes
Editor’s note: This post was first published in November 2015. Since then we have written extensively on the issue of medical devices and the MDR/IVDR. You can read more about devices here. You will see that some of our comprehensive...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsIVD DevicesMDD DevicesMedical Devices
EDMA Publishes a Position Paper on New EU IVD Regulation
In 2012, the European Commission proposed draft text for a new EU IVD regulation to replace the IVD directive 98/79/EC. Since publication, the text has undergone rounds of negotiation and revision, with the latest amendments being made by the European...
Acorn Regulatory to Exhibit at Med in Ireland – Dublin, October 29th 2015
Med in Ireland – October 29th 2015, Dublin Convention Centre, Ireland Acorn Regulatory is delighted to attend the Med in Ireland conference and exhibition on October 29th 2015. This biennial event is Enterprise Ireland’s largest medical technologies event, bringing together...
Medical Device Post-Market Obligations, a European Perspective: Part 2 – Assessing Product Changes
Last week, 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...
DCP Applications To Be Accepted Only in eCTD format from July 1st 2015
Looking back on how far we have progressed from the standard paper submission one thing is clear – the age of the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesIndustry NewsIVD DevicesMDD DevicesMedical Devices
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...
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Conducting Internal Audits – Guidance from our Quality Team
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. Guidance on conducting Internal Audits – ISO 9001:2008 ISO 9001:2008 8.2.2...
Acorn Regulatory's Top 100 ArticlesComplianceIVD DevicesMDD DevicesMedical DevicesPharmacovigilanceRegulatory Affairs
EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions
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...
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