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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

#medicaldevices: New MDCG 2024-10 report on clinical evaluation of orphan medical devices available Read more at: https://lnkd.in/eDChZ9Br #clinicalevaluation

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

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

#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

#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

#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

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