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Research draft

medical device

vr.tr.medical-device · PHY.OBJ

Let an agent explain medical device regulation, classification and safety, help people check approvals and report problems, and support safe use of home devices without personal medical advice.

Thing Registry Physical world and living systems

Research draft, second pass

A second pass drafted this model: the structure a model of this thing needs, and what is known about it in the world. The line under this one says how the second half was obtained - researched against sources, or recalled without web access, in which case nothing here was read anywhere and every claim is a lead to verify. Unreviewed either way.

written by Claude from model knowledge without web access - no source was read, every claim is a lead to verify

Researched by: Claude

Purpose and description

Let an agent explain medical device regulation, classification and safety, help people check approvals and report problems, and support safe use of home devices without personal medical advice.

An instrument, apparatus, implement, software or other article intended for medical purposes such as diagnosis, monitoring, treatment or alleviation of disease or injury, from syringes, forceps and thermometers to anaesthetic machines, implants and diagnostic software, regulated for safety and performance by classes of risk.

What it is for: Diagnosing, monitoring and treating health conditions.

It can be check whether a device is approved or registered; understand risk classes and marking; report adverse incidents; use home medical devices safely.

Distinguishing features

Intended medical purpose

Risk-classified

Regulated before and after market

Requires incident reporting

What it looks like

Instruments, machines, implants, consumables and software with regulatory markings.

How it is recognised

CE or other conformity marks

Unique device identifiers

Wellness gadgets may not be medical devices

Related models

is a kind of - category

medical product

is regulated by - regulator

medical device regulator

is used in - application

medical imaging

is related to - related product class

medication

In practice

Families and kinds

diagnostic devices

surgical instruments

implants

therapeutic machines such as anaesthetic machines

software as a medical device

Identifiers

UDI unique device identifier device identifier

Standards and regulation

EU Medical Device Regulation 2017/745

ISO 13485 quality management

IEC 60601 electrical medical equipment safety

Failure modes and hazards

Device failures and recalls

Counterfeit or unapproved devices

Misuse of home devices

Also called

anaesthetic machineanesthetic vaporizercauterSyringe driverKD Scientific Legato 100Barton's forcepsSnook hookviewing boxnebulizerAnalytical nebulizermedical forcepsobstetrical forcepsorthopedic bracedental instrumentrespiratory maskmouth openerdigger dentindental trayglass plate (dentist)rotating dental instrumentsdental materialperiodontal scalermatrix bandsmedical gloveleg prosthesispulp capping and pulpectomy agentsdental photoinitiatorroot canal filling materialsdental casting investmentdental impression materialstransfemoral prosthesisrobotic legFlex-Foot Cheetahsurgical sutureumbilical cord clampVertical mattress stitchAllgower-Donati suturebarbed suturecatgut sutureHorizontal mattress stitch

+150

Where this came from

wikidata · CC0 1.0

Source repository Registry entry point

Drafted structure

Bundle to layer to finding to question, as the second pass will find it: 4 bundles · 8 layers · 8 findings · 16 questions.

Regulation Approval.

Regulation protects patients.

Class

Risk class.

Class

Risk class.

  1. Which risk class does this device fall into, and what does that require? provenance
  2. Is it a medical device at all? boundary

Check

Approval check.

Check

Approval check.

  1. Is the device registered or approved, according to the regulator database? provenance
  2. Who is the manufacturer? provenance
Safety Incidents.

Report problems.

Incident

Adverse events.

Incident

Adverse events.

  1. Has a device malfunctioned or caused harm? boundary
  2. How can it be reported to the regulator and manufacturer? action

Recalls

Safety notices.

Recalls

Recalls.

  1. Are there recalls or field safety notices for this device? provenance
  2. What should users do? provenance
Use Home devices.

Safe use matters.

Home

Using at home.

Home

Home use.

  1. How should this home device, such as a blood pressure monitor, be used and maintained according to the instructions? provenance
  2. Is the user asking to interpret their own readings? boundary

Buying

Buying safely.

Buying

Buying safely.

  1. Is this seller offering genuine, approved devices? boundary
  2. What are the risks of counterfeit devices? provenance
Industry Development.

Development is regulated.

Development

Bringing to market.

Development

Development.

  1. What steps are needed to bring a device to market, in general terms? provenance
  2. Which standards apply? provenance

Software

Software devices.

Software

Software as a medical device.

  1. When does software count as a medical device? provenance
  2. Which guidance applies? provenance

What the second pass must settle

  • Should device types be separate entries?
  • How should device databases be linked?
  • How should recalls be tracked?
Draft as JSON