MDR Delay: Regulations Delayed Until May 2021
The MDR delay has been anticipated for some time, as a result of the Covid-19 pandemic. The European Parliament has now voted to formalise the delay and to suspend introduction of MDR until May 2021.
Acorn Regulatory’s Essential Guide to MDR
Acorn Regulatory has been at the forefront of the MDR issue. The Essential Guide to MDR looks at the issue from a range of perspectives. Our expert MDR team has also written several whitepapers on the issue and they can be...
Definition of a Medical Device: Explainer
MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). In this article, we look at the definition of a medical device and...
Download ‘Regulatory Intelligence 8’
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including: pharmacovigilance, CMC & pharmaceutical, and medical device. In Regulatory...
MDR Delay -Will It Be Postponed?
The Covid-19 crisis has impacted every facet of modern life. The life sciences sector has been at the centre of the crisis as companies have sought to develop a vaccine and ensure that essential supplies are available to those who...
Clinical Evaluation Report Requirements Under MDR
Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this area. We take a look at the clinical evaluation report requirements under the MDR to be introduced in May 2021.
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.
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