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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.
Recent newsletter stories have included issues related to MDR, Brexit, Eudravigilance, and other topical issues. We also feature expert-written articles by regulatory and pharmacovigilance specialists at Acorn Regulatory. Each month, they write new and exclusive articles that offer insights into the issues that impact on RA and PV professionals. You can read some of the past issues of the newsletter by clicking the links just beneath the form below.
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Further Reading from Acorn Regulatory
The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in May 2017 has new, stricter criteria for CER (Clinical Evaluation) reports, such as the basis of establishing an equivalence with another device and the quality of data considered in your clinical evaluation.
We consider the 5 issues that you should consider when creating a Clinical Evaluation Report. Read the article here.
The date of application of MDR of 26th May 2020 has long been recognised as a very ambitious target by many in the medical devices sector. The pressure among stakeholders whether they be economic operators, notified bodies or competent authorities to be ready in time has been intense. The delay of Eudamed and the well-documented issues around capacity in the Notified Body network are just two examples of areas of difficulty in being ready for MDR implementation.
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 can access our range of whitepapers and other articles that look at the changes that the new regulations will bring about.
Find out more about carrying out a clinical investigation under MDR here.