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New European Medical Device and IVD Regulation – Where is it?
The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on a little longer. Current predictions are that the new legislation will be adopted no sooner than Q4 2015, possibly extending...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesIndustry NewsIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesRegulatory Affairs
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...
