Europe - Aug 2019

August 30, 2019

  • Albania: Amendments proposed to ‘Law on Medical Devices’

  • EU: New MDCG documents on Notified Bodies, the person responsible for regulatory compliance, and implant cards

  • EU: Supplementary guidance released on the Medical Device Vigilance System

  • EU: Graphical symbols that may be used in order to comply with Regulation (EU) 2017/745

  • EU: EMA issues draft guidance on quality requirements for drug-device combinations

  • EU: Manual on borderline and classification issues updated

  • EU: List of designated issuing entities for UDIs formally published

  • France: Testing of new organisational requirements for clinical investigations under Regulation (EU) 2017/745

  • France: Recommendations drafted to tackle medical device cybersecurity threats

  • Germany: Mandatory implant registry expected to be operational from mid-2021

  • Netherlands: National implementation rules for the new European Regulations

  • Norway: Control of electromedical equipment has transferred to the Norwegian Medicines Agency

  • Switzerland: Draft revision of MepV plus new clinical trials Ordinance

     

     

     

     

     

     

     

     

     

 

 

Click here for the full article on Global Regulatory Press.

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