MHRA Moving Towards Paperless Communications
Following discussions with industry bodies, the MHRA is now replacing all paper-based communications with emails. The emails will replace paper-based communications about Common European Submissions Portal (CESP) submissions. Companies working with the MHRA will now receive emails to a single address...
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Overview of EU Regulatory Framework – Acorn Regulatory Presents at Industry Event
In the first Manufacturing Excellence event of 2016 held by County Tipperary Chamber on 12th February, Dr. Gemma Robinson (Managing Director of Acorn Regulatory) presented to a room full of Regulatory, Human Resource and Manufacturing Managers on ‘The Latest Developments in...
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EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions
In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD and medical device manufacturers. In this article, we are going to delve a bit deeper and answer some questions about vigilance...
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Do You Want To Find Out About CE Marking An App? Find Out More Here
There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians – everything from medication reminders to apps which calculate drug dosage. In this brief overview we look at CE Marking an App....
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Borderline Medical Devices Covered in EU Manual Update
With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly common. Indeed, many questions have been raised about borderline medical devices. In such cases, the intended purpose of the app...