ARCHETYPE ID | openEHR-EHR-CLUSTER.nes_ts-medical-device-regulatory-details.v0 |
Concept | nes_ts-medical-device-regulatory-details |
Description | NES_TS UK_MHRA Medical Device |
Use | Use 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. |
Misuse | Do 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. |
Purpose | This 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. |
References | Derived 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 |
Authors | Author name: Dr Paul Miller Organisation: NHS Education for Scotland Technology Service Email: paul.miller@nhs.scot Date originally authored: 2023-04-27 |
Other Details Language | Author 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: |
Keywords | mhra, device, regulatory, class, category, mdr |
Lifecycle | in_development |
UID | 907ea9e9-c6b7-4db9-82b4-4054ec93bf38 |
Language used | en |
Citeable Identifier | 1051.32.1183 |
Revision Number | 0.0.1-alpha |
All | Archetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=NES_TS UK_MHRA Medical Device , archetypeConceptComment=null, otherContributors=, originalLanguage=en, translators=, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={state=[], content=[], capabilities=[], relationships=[], activities=[], events=[], contacts=[], description=[], target=[], context=[], identities=[], protocol=[], other_participations=[], items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Class, description=The Class of device as defined by the associated regulatory body or policy, comment=For example, Class I, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Category, description=The category of the device, as defined by the associated regulatory body or policy, comment=For example, '1. Non Invasive', uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=SLOT, level=1, text=Extension, description=Additional information about the regulatory data values, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include: All not explicitly excluded archetypes, extendedValues=null]], details=[], provider=[], source=[], ism_transition=[], data=[], credentials=[]}, topLevelItems={items=ResourceSimplifiedHierarchyItem [path=ROOT_/, code=at0000, itemType=CLUSTER, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..*, cardinalityText= , subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=items, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Class, description=The Class of device as defined by the associated regulatory body or policy, comment=For example, Class I, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Category, description=The category of the device, as defined by the associated regulatory body or policy, comment=For example, '1. Non Invasive', uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=SLOT, level=1, text=Extension, description=Additional information about the regulatory data values, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include: All not explicitly excluded archetypes, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null] |