The Risk Based Classification System Under IVDR 2017/746
One of the key changes in the new IVDR Regulation 2017/746, is the introduction of a risk-based classification system for IVD devices. Under the new risk-based classification system, the majority of IVD devices will need to undergo a Notified Body...
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PRRC: The 5 Responsibilities of the Person Responsible for Regulatory Compliance under MDR
This article is part of our series of MDR articles that look at the changes coming into play with the new medical device regulations. In this article, we are looking at the role of the Person Responsible for Regulatory Compliance...
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The Acorn Regulatory Newsletter is read by life science professionals around the world every month. We cover the stories that impact on pharmaceutical and medical device regulations.
Carrying Out A Clinical Investigation Under MDR
As part of our ongoing MDR series, we are looking at clinical investigations and how they will operate after the MDR has been introduced. We have written extensively on the MDR issues and at the end of this article, you...
Conformity Assessment Routes Under MDR 2017/745
As part of our ongoing look at the changes being brought about by MDR, we look at Conformity Assessment routes. We look at changes under MDR and the assessment routes for different device classifications.
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The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR.
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Six Responsibilities of Importers and Distributors under MDR 2017/745
MDR 2017/745, which comes into force on May 26th, 2020, greatly expands the responsibilities of importers and distributors in comparison to the current MDD 93/42/EEC. In this article, we look at the responsibilities of the importer and the distributor.
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Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing. Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download.
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