Manufacturer incident report 2020
Manufacturer incident report for importing XML file with Adobe Professional 2020
EU – Manufacturer incident report 2020
Published in Active Implantable Medical Devices Directive - AIMDD, In Vitro Diagnostic Medical Device Regulation IVDR, In Vitro Diagnostic Medical Devices Directive - IVDMDD, Manufacturer Incident Report (MIR), Medical Device Regulation MDR and Medical Devices Directive - MDD
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- EU – Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
- EU – MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- EU – Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
- Joint Action on Market Surveillance of Medical Devices (JAMS) Stakeholder Conference Held In Brussels On Dec. 12th 2019
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- EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- EU – Ongoing Guidance development within MDCG Subgroups
- EU – Privacy statement – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
- EU – Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
More from In Vitro Diagnostic Medical Devices Directive - IVDMDDMore posts in In Vitro Diagnostic Medical Devices Directive - IVDMDD »
- EU – Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- EU – Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
- Joint Action on Market Surveillance of Medical Devices (JAMS) Stakeholder Conference Held In Brussels On Dec. 12th 2019
- EU – Official position on EUDAMED delay
More from Medical Device Regulation MDRMore posts in Medical Device Regulation MDR »
- EU – Guidance – Clinical evaluation assessment report template
- EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
- UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
- EU – COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
More from Medical Devices Directive - MDDMore posts in Medical Devices Directive - MDD »
- EU – Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
- EU – MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
- EU – REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- EU – Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
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