Medical device manufacturers who want to bring their devices onto the Union market, must understand three essential elements when complying to the MDD. Device manufacturers that want to enter into the EU Market need to understand three essential ideas: the role of the competent authorities, contract with an EU Authorised Representative, and how to use
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STRASBOURG – The European Parliament is aiming to tighten controls on the safety of medical devices in the wake of a worldwide scare over faulty breast implants from France. More than 16,000 women have had breast implants removed since it was found in 2011 that those from France’s Poly Implant Prothese (PIP) were twice as
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On May 5th 2017 the Official Journal of the European Union published the new Medical Devices Regulation (EU) 2017/45. According to the new Medical Devices Regulation the Regulation enters into force on May 26th 2017. The current legislation on medical devices, i.e. the Medical Devices Directive 93/42/EEC, will be repealed with effect from May 26th 2020. As such there will be a transitional period of three years for all parties concerned with medical devices to adjust their activities in order to comply with the new Medical Devices Regulation.
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In order to determine whether your standalone software is considered to be a medical device it must first be determined what type of operating software is to be used. For example, is your software online software that runs through an internet browser, standalone software that operates without internet connection, or a program running separate from
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