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EU: EMA issues draft guidance on quality requirements for drug-device combinations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