State of play of joint assessments of Notified Bodies in the medical device sector

EU – State of play of joint assessments of Notified Bodies in the medical device sector
More from In Vitro Diagnostic Medical Device Regulation IVDRMore posts in In Vitro Diagnostic Medical Device Regulation IVDR »
- 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 – Manufacturer incident report 2020
- 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)
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- 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
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- EU – Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
- EU – New notified body designated under the MDR – NB 2862 -Intertek Medical Notified Body AB
- EU – Team-NB – Contacts to allow the check of the validity of the CE certificates
- EU – New notified body designated under the MDR – NB 0483 – MDC MEDICAL DEVICE CERTIFICATION GMBH
- EU – MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
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