mdr-745-specialist

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.

0.98x

Quality

70%

Does it follow best practices?

Impact

96%

0.98x

Average score across 6 eval scenarios

Securityby

Passed

No known issues

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Evaluation results

100%

MDR Classification and Compliance Assessment for AI Early Warning System

Software device classification and compliance gap analysis

Criteria

Without context

With context

Software device type identified

100%

MDCG 2019-11 referenced

100%

Rule 11 applied

100%

Condition severity assessed

100%

Correct device class

100%

Duration/invasiveness factors addressed

100%

Classification rationale documented

100%

Conformity assessment route stated

100%

Gap analyzer tool used

100%

Correct class used in gap analysis

100%

Critical gaps identified

100%

88%

-9%

Technical Documentation and Clinical Evidence Plan for Cardiac Monitor

Technical documentation structure and clinical evidence strategy

Criteria

Without context

With context

Annex II structure

100%

GSPR evidence linkage

100%

Software GSPR 17 included

100%

28%

GSPR 10.1 and 10.2 included

85%

28%

PICO framework used

100%

Multiple databases selected

100%

Equivalence per MDCG 2020-5

100%

CER structure completeness

86%

100%

Qualified evaluator requirements

100%

ISO 14971 integration

100%

71%

Reproducible search documented

100%

Data appraisal criteria included

100%

11%

Post-Market Surveillance System and UDI Implementation for Class IIb Ventilator

Post-market surveillance system and UDI labeling requirements

Criteria

Without context

With context

PMS Article 84 plan

100%

PMS system components

100%

Annual PMS audit

100%

2-day reporting timeline

100%

10-day reporting timeline

100%

15-day reporting timeline

100%

Class IIb PSUR frequency

100%

PMCF plan sections

87%

100%

PMCF Annex XIV Part B

100%

UDI-DI and UDI-PI distinction

100%

UDI-PI required for Class II+

100%

AIDC and HRI both required

100%

Issuing entity identified

100%

88%

-12%

MDR Classification for a New Spinal Fixation System

Physical device classification and conformity route selection

Criteria

Without context

With context

Duration factor assessed

100%

Invasiveness level assessed

100%

Body system contact assessed

100%

Active vs passive assessed

100%

Rule 8 applied

100%

Correct device class

100%

Classification rationale documented

100%

Conformity routes for class listed

100%

QMS maturity considered

100%

NB capacity/timeline considered

100%

Gap analyzer tool used

100%

Correct class in gap analysis

100%

Planning a Clinical Investigation for a Novel Class III Cardiac Valve

Clinical investigation planning and ethics committee submission

Criteria

Without context

With context

Article 61(4) cited

100%

Novel technology basis

100%

CIP objectives section

100%

CIP study design section

100%

CIP population section

100%

CIP sample size section

100%

CIP safety section

100%

CIP analysis section

100%

Ethics submission: CIP included

100%

Ethics submission: Investigator's Brochure

100%

Ethics submission: informed consent

100%

Ethics submission: insurance

100%

SAE reporting timeline 7-15 days

100%

EUDAMED reporting channel

100%

GCP reference

60%

100%

EU Market Entry: Notified Body Selection and EUDAMED Registration

Notified Body selection and EUDAMED registration workflow

Criteria

Without context

With context

NB designation scope criterion

100%

NB capacity criterion

100%

NB geographic reach criterion

100%

NB technical expertise criterion

100%

NB fee structure criterion

100%

EUDAMED Actor module

100%

EUDAMED UDI/Device module

100%

EUDAMED Vigilance module

100%

EUDAMED Certificates module

100%

UDI issuing entity named

100%

UDI-DI and UDI-PI assigned

100%

Pre-submission: technical documentation

100%

Pre-submission: GSPR matrix

100%

Pre-submission: CER

100%

Pre-submission: QMS certification

80%

100%

Pre-submission: labeling and IFU

100%

Pre-submission: declaration of conformity

100%

Repository: alirezarezvani/claude-skills
Commit: 967fe01

Evaluated: 25 days ago
Agent: Claude Code
Model: Claude Sonnet 4.6

Table of Contents

MDR Classification and Compliance Assessment for AI Early Warning System Technical Documentation and Clinical Evidence Plan for Cardiac Monitor Post-Market Surveillance System and UDI Implementation for Class IIb Ventilator MDR Classification for a New Spinal Fixation System Planning a Clinical Investigation for a Novel Class III Cardiac Valve EU Market Entry: Notified Body Selection and EUDAMED Registration

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