Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
Published in Benefit-Risk Determination, European Commission, Guidance, Medical Device Regulation MDR and Phthalates
More from Benefit-Risk DeterminationMore posts in Benefit-Risk Determination »
- USA – Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
- US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
More from European CommissionMore posts in European Commission »
- 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 – 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 relocated website for medical devices in the EU Commission website
More from GuidanceMore posts in Guidance »
- EU – MDCG 2020-5 Clinical Evaluation – Equivalence. 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
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- UU – Final guidance – Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
- US Final Guidance – Bone Anchors – Premarket Notification (510(k)) Submissions
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 PhthalatesMore posts in Phthalates »
- EU – Why are potential dangerous phthalates allowed in medical devices, and who decides if their use is warranted?
- EU – 12th Meeting of the Working Group on Guidelines on benefit – risk assessment of Phthalates in Medical Devices
- EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records and presentations now available
- PUBLIC CONSULTATION ON PHTHALATES IN MEDICAL DEVICES
Be First to Comment