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...
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.
Post Market Surveillance under Medical Device Directive (2017/745)
Regulation (EU) 2017/745 on medical devices (MDR) now has increased requirements on specific Post Market Surveillance (PMS) and Post-market clinical follow-up (PMCF) requirements. In this article, we look at the requirements for manufacturers.
Download the 3rd Acorn Regulatory MDR Whitepaper
The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR.
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.
How Unique Device Identifiers Will Work Under MDR
The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim to improve patient safety through better traceability and transparency. Both...
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Steps to CE Marking an IVD Medical Device
One of the most frequent questions we are asked is: how do you CE mark an IVD device? We will look at the steps that you need to take to obtain when CE marking an IVD device. As the new...
Most Read Medical Device Articles of 2019
2019 has been a busy year for people involved in the medical devices sector. The imminent arrival of MDR, on May 26th next year, is concentrating the minds of those within the industry. It has been a busy year also...
