Europe - Jun 2019

  • Czech Republic: Form released for accessing online reimbursement system

  • EU: Corrigenda published to Regulations 2017/745 and 2017/746

  • EU: MDCG clarifies scope of clinical evaluation consultation procedure

  • EU: EMA issues Q&A document to assist with implementation of Article 117 of Regulation (EU) 2017/745

  • EU: MDCG issues new and updated guidance on UDI

  • EU: Details of EUDAMED nomenclature system unveiled

  • EU: More EUDAMED guidance on timelines for registration of device data elements, and registering legacy devices

  • EU: Commission’s rolling plan on MDR/IVDR implementation updated again

  • EU: Manual on borderline and classification issues updated

  • EU: Consultation held on benefit-risk assessment of phthalates in certain medical devices

  • Finland: Medical device control being transferred from Valvira to Fimea

  • France: Submission of files to the CNEDiMTS for reimbursement purposes must be done electronically

  • Germany: National implant register to be established

  • Portugal: Presentation of medical device code in NHS contracting procedures; development of an Integrated Medical Device Monitoring System

  • Switzerland: Requirements for ordering Certificates of Free Sale have been modified

  • UK: Guidance on virtual manufacturing of medical devices recently updated

  • UK: Brexit update

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