EU – REACH Authorisation Decisions List
Published in Biological Evaluation, European Commission, In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR and Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
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- Grey literature and medical devices
- TGA – Current status of breast implant products in Australia
- Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS)
- US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review
- US FDA paper – Biological Responses to Metal Implants
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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 – 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 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)
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 Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)More posts in Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) »
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