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#Medicaldevices: #MDCG updates its guidance MDCG 2021-5 on various aspects of medical device standards. Read more at: https://lnkd.in/ebd8-Qqm #regulatorycompliance
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#medicaldevices: New MDCG 2024-10 report on clinical evaluation of orphan medical devices available Read more at: https://lnkd.in/eDChZ9Br #clinicalevaluation
New MDCG 2024-10: Clinical Evaluation of Orphan Medical Devices
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New trends in biological evalutation of #medicaldevices: The standard EN ISO 10993-1 is currently under revision with several important amendments being proposed. Read more about the changes to come at: https://lnkd.in/edVQFypu #biologicalevaluation
Trends in Biological Evaluations: New Draft Version of EN ISO 10993-1
https://scc-medical-devices.com
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European Commission updates Guideline MDCG 2022-4 on appropriate surveillance of the transitional provisions regarding devices covered by certificates under the MMD and IVDD: https://lnkd.in/eGxi3B96 #medicaldevice #regulatorycompliance #regulatoryaffairs
EC updates Guideline MDCG 2022-4
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#UKREACH: #Defra releases proposal for Alternative Transitional Registration Model (ATRm). The proposal is open for public consultation until 11 July 2024. Further details can be found at: https://lnkd.in/eGB9_qMU
UK REACH: Defra releases proposal for alternatove transitional registration model
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#euparliament approves the proposal for the gradual introduction of #EUDAMED, the transitional arrangements for #IVDs and obligation to report supply disruptions. Read more at: https://lnkd.in/ebwr97hT #medicaldevices #regulatorycompliance #mdr #ivdr
Amendment Proposal of MDR and IVDR: EU Parliament Approves Proposed Measures
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#europeancommission issued guiding criteria and principles for the essential uses of the most harmful #chemicals allowing them only when their use is necessary for health and/or safety and/or critical for the functioning of society and when there are no acceptable alternatives. Read more here: https://lnkd.in/dTXT-tzS #chemicalsregulation #chemicalscompliance #regulatoryaffairs #harmfulchemicals
European Commission Issued Guiding Criteria and Principles for the Essential Use Concept
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