Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
Implications of Brexit for the Medical Device Sector
In this extract from our first Brexit whitepaper, written in July 2016, we look at the implications of Brexit for the medical device sector.
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.
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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...
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...
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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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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesPharmacovigilance
EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceFeatured NewsHow-To & ExplainersIndustry NewsIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesRegulatory Affairs
Do You Want To Find Out About CE Marking An App? Find Out More Here
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....
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