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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.
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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.