Primeiro NB designado para o MDR – BSi UK
First NB designated to the EU MDR regulation – BSI UK
Published in Medical Device Regulation MDR, Notified Body and UK
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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
More from Notified BodyMore posts in Notified Body »
- 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
More from UKMore posts in UK »
- UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
- UK – Independent Medicines and Medical Devices Safety Review report and MHRA response
- UK – MHRA – Effective field safety notices (FSNs): guidance for manufacturers of medical devices
- UK – Medicines and Medical Devices Bill: overarching documents
- Ireland – HPRA update – Brexit Transitional Period: Implications for Medicine and Medical Device Companies up to 31 December 2020
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