Europe - April 2017

  • Europe: Latest timings on the new Regulations for medical devices and IVDs

  • Europe: Products whose principal intended action (depending on PAC present in cranberry) is to prevent or treat cystitis, should not be medical devices

  • Europe: Joint Action on Market Surveillance of Medical Devices launched at 39th CAMD meeting

  • Europe: Eucomed and EDMA formally merge to create MedTech Europe

  • France: Advice for French manufacturers if their Notified Bodies cease operations

  • Sweden: Responsibility for Notified Bodies to transfer to MPA from SWEDAC

  • Switzerland: Grace period for manufacturers affected by the de-designation of their Notified Body

  • UK: Significant fee increases proposed by MHRA to aid cost recovery

Click here for the full article on Global Regulatory Press.

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Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

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