Europe - May 2017

  • Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations

  • Europe: Court of Justice delivers its judgment on PIP breast implants case

  • Europe: Proposed updates to Common Technical Specifications for certain IVDs

  • Europe: SCHEER issues preliminary Opinion on use of non-human primates in biomedical research, production and testing of products and devices

  • Finland: Markus Henriksson appointed to lead Valvira

  • France: New obligations for Class III and implantable medical device manufacturers

  • Ireland: Draft guide to Good Distribution Practice for medical devices and in vitro diagnostics

  • Switzerland: New restrictions proposed for elemental mercury and mercury compounds, including use in dental amalgam

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

  • UK: MHRA updates guidance on the regulations affecting medical devices and how the Agency enforces them

  • UK: Virtual manufacturing replaces own brand labelling

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