MDR 2017/745 Specialist

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.

Device Classification (Annex VIII)

1. Identify duration (transient, short-term, long-term)
2. Determine invasiveness (non-invasive, body orifice, surgical)
3. Assess body system contact (CNS, cardiac, other)
4. Check if active device (energy dependent)
5. Apply classification rules 1-22; for software, apply MDCG 2019-11
6. Document classification rationale
7. Validation: Classification confirmed with Notified Body

Classification Matrix

Factor	Class I	Class IIa	Class IIb	Class III
Duration	Any	Short-term	Long-term	Long-term
Invasiveness	Non-invasive	Body orifice	Surgical	Implantable
System	Any	Non-critical	Critical organs	CNS/cardiac

For complete Annex VIII rules, software classification (MDCG 2019-11), and worked examples, see references/mdr-classification-guide.md.

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Technical Documentation (Annex II/III)

1. Create device description (variants, accessories, intended purpose)
2. Develop labeling (Article 13, IFU)
3. Document design and manufacturing process
4. Complete GSPR compliance matrix
5. Prepare benefit-risk analysis
6. Compile V&V evidence, integrate risk management file (ISO 14971)
7. Validation: Technical file reviewed for completeness

Conformity Assessment Routes

Class	Route	NB Involvement
I	Annex II self-declaration	None
IIa	Annex II + IX or XI	Product or QMS
IIb	Annex IX + X or X + XI	Type exam + production
III	Annex IX + X	Full QMS + type exam

For GSPR checklist template, technical file structure, and DoC template, see references/technical-documentation-templates.md.

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Clinical Evidence (Annex XIV)

1. Define clinical claims and endpoints
2. Conduct systematic literature search
3. Appraise data quality, assess equivalence
4. Identify evidence gaps, determine if investigation required
5. Prepare Clinical Evaluation Report (CER)
6. Validation: CER reviewed by qualified evaluator

Class	Minimum Evidence	Investigation
I	Risk-benefit analysis	Not typically required
IIa	Literature + post-market	May be required
IIb	Systematic literature review	Often required
III	Comprehensive clinical data	Required (Article 61)

For CER structure, qualified evaluator requirements, and PMCF guidance, see references/clinical-evidence-requirements.md.

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Post-Market Surveillance

Component	Requirement	Frequency
PMS Plan	Article 84	Maintain current
PSUR	Class IIa+	Per class schedule
PMCF Plan	Annex XIV Part B	Update with CER
Vigilance	Articles 87-92	As events occur

Serious incident reporting: 2 days (public health threat), 10 days (death/serious), 15 days (other).

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EUDAMED and UDI

1. Obtain issuing entity code (GS1, HIBCC, ICCBBA)
2. Assign UDI-DI/UDI-PI, apply carriers to labels
3. Register in EUDAMED (actor, devices, certificates)
4. Validation: UDI verified on sample labels

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Tools and References

python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa

Document	Content
mdr-classification-guide.md	Annex VIII rules, software classification, examples
clinical-evidence-requirements.md	CER structure, PMCF guidance
technical-documentation-templates.md	Annex II/III content, GSPR matrix, DoC