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mdr_compliance_check

EU MDR 2017/745 compliance assessment for medical devices. Checks CE marking, Notified Body, Clinical Evaluation, PMS, UDI, QMS, EUDAMED. Returns compliance score.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
device_nameNoDevice name
has_ce_markNo
device_classNoI, IIa, IIb, or III
udi_assignedNo
has_notified_bodyNo
eudamed_registeredNo
clinical_evaluationNo
post_market_surveillanceNo
quality_management_systemNo

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observed

TDQS

A4.1/5.0
Behavior3/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

With no annotations provided, the description carries the full transparency burden. It discloses the inputs checked and the output (compliance score) but does not mention whether the operation is read-only, how the score is computed, the score range, or how missing boolean fields are handled. This is moderate transparency but leaves gaps.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness5/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The description is two sentences, front-loads the core purpose, and each word adds value. It efficiently lists the checks and the return type without redundancy.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness3/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

The tool has 9 parameters and no output schema, so the description must be self-sufficient. It covers the purpose, the factor areas checked, and the return of a compliance score. However, it omits the score interpretation, whether missing parameters are treated as false, and any prerequisites like device class. This is adequate but not fully complete for a tool with this many inputs.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters4/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is only 22% (device_name and device_class have descriptions, booleans only have types). The description compensates by listing the compliance checks (CE marking, Notified Body, Clinical Evaluation, PMS, UDI, QMS, EUDAMED), which map to the boolean parameters and give them meaning. It does not explain exact parameter value effects or score calculation, but it adds significant semantic context.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description clearly states the tool performs 'EU MDR 2017/745 compliance assessment for medical devices' and specifies it checks CE marking, Notified Body, Clinical Evaluation, PMS, UDI, QMS, and EUDAMED, returning a compliance score. This distinct verb+resource combination separates it from sibling tools like ivdr_check and udi_validate.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines4/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The description gives clear context: use this for EU MDR compliance assessment of medical devices. It does not explicitly exclude non-medical devices or mention alternatives, but the reference to EU MDR 2017/745 and the sibling ivdr_check imply differentiation. No explicit 'when not to use' is provided, so it stops short of a 5.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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