Medical Device and FDA Regulations and Standards News

Marcelo follows sandards closely. A link to his website is in all the threads he has posted in this forum. If you like, you can post Medical Device and FDA Regulations and Standards News, too. Just start a New Discussion (thread).

Discussions
Marcelo Antunes
Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re
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3
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184
Susan
J
Exporting Medical Devices - What is needed from the receiver?
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1
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71
Ronen E
Marcelo Antunes
Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’
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2
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233
Watchcat
Marcelo Antunes
Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule
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0
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53
Marcelo Antunes
Marcelo Antunes
Informational Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of
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2
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161
Marcelo Antunes
Marcelo Antunes
Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o
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0
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76
Marcelo Antunes
Marcelo Antunes
Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity
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0
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69
Marcelo Antunes
Marcelo Antunes
Informational US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
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0
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53
Marcelo Antunes
Marcelo Antunes
Informational Health Canada – Mandatory reporting requirements for hospitals
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0
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64
Marcelo Antunes
Marcelo Antunes
Informational EU – Eudamed Data exchange services and entity models introductions
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3
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183
Ronen E
Marcelo Antunes
Informational US FDA draft guidance. – Clinical Investigations for Prostate Tissue Ablation Devices
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2
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79
Marcelo Antunes
Marcelo Antunes
Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019
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2
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337
Marcelo Antunes
Marcelo Antunes
Informational Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR
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0
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115
Marcelo Antunes
Marcelo Antunes
Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019
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0
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121
Marcelo Antunes
Marcelo Antunes
Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices
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9
Views
468
Marcelo Antunes
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