Conformity Assessment Routes Under MDR 2017/745
As part of our ongoing review at the changes introduced with MDR, in this article we focus on Conformity Assessment routes. We provide a revised examination of the changes under MDR and the assessment routes for different device classifications.
Understanding the Changes of MDR in 2021
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations have brought about many changes compared to the previous regulatory framework. We look...
Most Read Brexit Articles of 2020
Acorn Regulatory has led the way in providing information and assistance to industry professionals since 2016. We have compiled some of the most read and useful articles in one place to help you to better understand how Brexit will impact...
Acorn Regulatory To Sponsor Global Access Conference 2020
Acorn Regulatory has announced that it will be one of the Silver Sponsors for the 2020 Global Access Conference hosted by Irish Medtech. The conference will be held virtually on October 29th and 30th. The conference, the largest medical device...
The Competent Authorities Response to Covid-19
COVID-19 has transformed almost every aspect of our daily lives. Nevertheless, patient safety must remain a priority. COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work. Public health needs may...
Acorn Regulatory’s Essential Guide to Brexit
Acorn Regulatory has led the way in providing information and assistance to industry professionals since 2016. We have compiled some of the most read and useful articles in one place to help you to better understand how Brexit will impact...
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.
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Medicinal Product Labelling: What You Need To Know
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitEU Authorised RepresentativeHow-To & Explainers
Moving EU Authorised Representative: Find Out How To Move
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to consider moving EU Authorised Representative very soon to ensure that you have representation with the European Union...
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The Acorn Regulatory newsletter helps regulatory specialists and life science executives stay up to date with the constant changes that impact the sector by sharing the latest insights from our expert team. Since 2016 our monthly newsletter has been landing...
