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Medical Device regulation

Medical Device regulation

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Medical Device regulation

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  1. www.prorelixresearch.com

  2. Medical Device Regulation: what is it about? The EU’s Medical Device Regulation (MDR) is a hot topic in healthcare since it was officially published on 5th May 2017 and came into effect on 25 May 2017. The MDR replaces the EU Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). www.prorelixresearch.com

  3. Manufacturers of currently approved medical devices were given a transitional period during which they had to reorganize the operations to meet the requirements of the MDR. An amendment to the MDR was adopted on 24 April 2020 by European Commission, www.prorelixresearch.com

  4. which postponed the application of most of its provisions by one year, until 26 May 2021. However, certain devices that meet special requirements can be granted permission to extend the transition period till the 26th of May 2024. www.prorelixresearch.com

  5. Post-market surveillance: what’s new Articles 82 through 86 and Annex III of the EU MDR describe the requirements for a post-market surveillance system (PMS), making PMS mandatory, and those manufacturers who want to remain in compliance with new MDR are obliged to re-organize the PMS and Vigilance System following the new requirement. . www.prorelixresearch.com

  6. ProRelix Research is here for the timely execution of your projects! www.prorelixresearch.com

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