ARCHETYPE nes_ts-medical-device-regulatory-details (openEHR-EHR-CLUSTER.nes_ts-medical-device-regulatory-details.v0)

ARCHETYPE IDopenEHR-EHR-CLUSTER.nes_ts-medical-device-regulatory-details.v0
Conceptnes_ts-medical-device-regulatory-details
DescriptionNES_TS UK_MHRA Medical Device
UseUse inside the Medical Device or Medical Device Details clusters to allow the recording of taxonomical definitions of attributes relating to the regulation of medical devices, such as Class and Category.
MisuseDo not use this cluster for other medical device details, all of which should be captured in other medical device archetypes. If the required data can be externally referenced then it may be more appropriate to do that rather than persist the data inside the EHR.
PurposeThis cluster is to support the requirement to record 'Class' and possibly other values as part of a medical device record., where it is necessary to store these values in the EHR. Its initial purpose is specifically to enable the recording of the 'Class' of a medical device as defined in the United Kingdom's "Medicines and Healthcare products Regulatory Agency" (MHRA) requirements.
ReferencesDerived from: <Add reference to original resource here>

https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
Copyright© Apperta Foundation
AuthorsAuthor name: Dr Paul Miller
Organisation: NHS Education for Scotland Technology Service
Email: paul.miller@nhs.scot
Date originally authored: 2023-04-27
Other Details LanguageAuthor name: Dr Paul Miller
Organisation: NHS Education for Scotland Technology Service
Email: paul.miller@nhs.scot
Date originally authored: 2023-04-27
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=Apperta UK, references=Derived from: https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview, original_namespace=uk.org.clinicalmodels, original_publisher=Apperta UK, custodian_namespace=uk.org.clinicalmodels, MD5-CAM-1.0.1=D7B3980EACDBD64DDB03467198D87469, build_uid=20952325-3d5f-4a45-82ea-4c4ab333ad80, revision=0.0.1-alpha}
Keywordsmhra, device, regulatory, class, category, mdr
Lifecyclein_development
UID907ea9e9-c6b7-4db9-82b4-4054ec93bf38
Language useden
Citeable Identifier1051.32.1183
Revision Number0.0.1-alpha
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, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=SLOT, level=1, text=Regulating organisation, description=The organisation that provides the values and definitions of the associated regulatory device metadata., comment=For example, UK MHRA., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
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, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Other, description=Any additional allocated taxonomy values not elsewhere available, comment=For example, 'Type', 'Branch', 'Chapter', uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
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, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=SLOT, level=1, text=Regulating organisation, description=The organisation that provides the values and definitions of the associated regulatory device metadata., comment=For example, UK MHRA., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
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