CE Marking a Medical Device That Incorporates a Medicine
We are consistently asked about CE marking a medical device. Our team of medical device experts has written a brief overview of how a company can secure CE marking for a medical device that incorporates a medicine.
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Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
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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...
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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...
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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...
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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...
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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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