medical-device-compliance

name	medical-device-compliance
description	Use when developing, manufacturing, or selling medical devices, IVDs, software as a medical device (SaMD), or wellness products that cross the medical-device threshold in any market - covers EU MDR/IVDR, FDA 510(k)/PMA/De Novo, UKCA MDR, classification, Notified Body selection, UDI, post-market surveillance

Medical Device Compliance

Full regulatory workflow for medical devices, IVDs, and software as a medical device (SaMD). EU MDR/IVDR, FDA, UKCA, classification, clinical evaluation, post-market.

Decision Flow

digraph {
  rankdir=TB; node [shape=box style=rounded fontsize=10];
  qualify [label="1. Qualify as medical device\n(MDR Art. 2, FDA 201(h))"];
  classify [label="2. Classify:\nEU I/IIa/IIb/III, FDA I/II/III"];
  pathway [label="3. Choose pathway:\nself-cert / NB / 510(k) / PMA / De Novo"];
  qms [label="4. QMS ISO 13485\n+ Risk mgmt ISO 14971"];
  clinical [label="5. Clinical evaluation\n(MEDDEV 2.7/1 rev 4)"];
  tech [label="6. Technical Documentation\n(MDR Annex II/III)"];
  audit [label="7. NB audit / 510(k) review\n/ PMA submission"];
  udi [label="8. UDI assignment\n+ EUDAMED registration"];
  pms [label="9. Post-Market Surveillance\nplan + PMCF"];
  sell [label="10. Place on market"];
  qualify -> classify -> pathway -> qms -> clinical -> tech -> audit -> udi -> pms -> sell;
}

EU -- MDR 2017/745

Requirement	Detail
Legal basis	Regulation (EU) 2017/745 (MDR) -- fully applicable since 26 May 2021. Transitional provisions to 26 Dec 2027 (Class III/IIb implantables) and 31 Dec 2028 (other Class IIa/IIb/Im/Is/Ir) per Reg 2023/607
Classification	Annex VIII rules 1-22. Class I (low risk), IIa (medium), IIb (medium-high), III (high risk). Software per Rule 11 (most clinical SaMD = Class IIa minimum)
Pathway	Class I non-sterile/non-measuring: self-declaration. Class Is/Im/Ir: Notified Body for sterility/measurement/reusable aspect only. Class IIa+: full NB conformity assessment (Annex IX or X)
Notified Body	~50 NB designated under MDR (vs 80+ under old MDD). 18-24 month wait times. List: NANDO database
Technical Documentation	MDR Annex II + III: device description, design info, GSPR checklist (Annex I), risk management ISO 14971, verification/validation, clinical evaluation, labeling, PMS plan
Clinical evaluation	MDR Article 61 + Annex XIV. MEDDEV 2.7/1 rev 4 still referenced. Equivalence routes restricted under MDR. Implants + Class III need own clinical investigations
QMS	ISO 13485:2016 required. Annex IX requires NB to audit QMS
UDI	Basic UDI-DI + UDI-DI (production identifier). Carrier: GS1, HIBCC, ICCBBA. Direct marking on reusable devices
EUDAMED	EU database. Modules: Actor registration (live), UDI/Device (live but voluntary), NB/Certificate (live), Clinical Investigation (partial), Vigilance (live), PMS (pending). Mandatory use phased
Authorized Representative	Non-EU manufacturers MUST appoint EU AR (MDR Article 11)
Timeline	Class I: 1-3 months. Class IIa: 8-14 months (incl. NB wait). Class IIb: 12-18 months. Class III: 18-36 months
Cost	Class I: EUR 5,000-30,000. Class IIa: EUR 50,000-200,000 + NB fees EUR 30,000-100,000/year. Class III: EUR 500,000-2,000,000+

EU -- IVDR 2017/746 (In Vitro Diagnostics)

Requirement	Detail
Legal basis	Reg (EU) 2017/746 -- date of application 26 May 2022. Transition extended by Reg 2024/1860: Class D to Dec 2027, Class C to Dec 2028, Class B to Dec 2029, Class A sterile to Dec 2029
Classification	7 rules (Annex VIII). Class A (low, self-cert), B (medium-low, NB for QMS), C (medium-high, NB full), D (high risk, NB + EU Reference Lab)
Massive shift from IVDD	~80% of IVDs now require NB involvement (was ~20% under IVDD). Critical NB capacity shortage
CS (Common Specifications)	Mandatory for Class D devices. Annex I performance + safety
Performance evaluation	Analytical + clinical performance + scientific validity. PER (Performance Evaluation Report)
In-house exception	IVDs manufactured and used within the same health institution exempt from CE marking but must meet GSPRs and document compliance
Cost	Class A: EUR 10,000-50,000. Class B: EUR 50,000-150,000. Class C/D: EUR 150,000-800,000 +

US -- FDA Pathways

Pathway	Use	Timeline	User Fee FY2026
510(k) Premarket Notification	Class II (most). Demonstrate substantial equivalence to predicate. Class III by 510(k) for grandfathered devices	90-day FDA target (actual: 4-9 months)	$24,335 standard; $6,084 small business
PMA (Premarket Approval)	Class III high-risk devices (e.g., implantable defibrillators, life-sustaining)	180-day FDA target (actual: 12-24 months)	$507,505 standard; $126,876 small business
De Novo	Novel low/moderate risk devices with no predicate. Pathway to Class I/II for new device types	150-day FDA target (actual: 10-18 months)	$172,553 standard; $43,138 small business
510(k) exempt	~75% of Class I devices and many Class II. Still subject to general controls + listing	Immediate	$0 (only listing fee $9,280 annual establishment)
HDE (Humanitarian Device Exemption)	Rare diseases <8,000 patients/year US. Limited evidence	75-day FDA target	$4,867
Breakthrough Devices	Designation accelerates review for serious conditions	--	Same as 510(k)/PMA + priority

FDA Classification

Class	Risk	Controls	Examples
Class I	Low	General controls only	Tongue depressors, exam gloves, manual stethoscopes
Class II	Moderate	General + special controls (510(k) usually required)	Powered wheelchairs, infusion pumps, blood pressure monitors
Class III	High	PMA required	Heart valves, implantable pacemakers, deep brain stimulators

FDA Software (SaMD)

• Software functions that meet the definition of a "device" under section 201(h) regulated
• 21st Century Cures Act 2016 excluded certain wellness software, EHR functions
• Pre-Cert pilot program ended 2023; FDA returning to traditional 510(k) for SaMD
• AI/ML: PCCP (Predetermined Change Control Plan) framework finalized 2024 -- allows pre-authorized algorithm updates

UK -- UKCA / UK MDR

Requirement	Detail
Legal basis	UK Medical Devices Regulations 2002 (as amended). New UK MDR consultation 2024-2026 to align/diverge from EU MDR
CE acceptance	CE marked devices accepted in GB until 30 June 2030 (extended by Statutory Instrument 2024)
UKCA marking	Required if new UK-specific routes used. Limited UK Approved Bodies (BSI UK, SGS UK, TUV SUD UK)
UKRP	UK Responsible Person required for non-UK manufacturers (since Jan 2021). Must be GB-established. Functions equivalent to EU AR
MHRA registration	All devices placed on UK market must be registered with MHRA. Free for Class I, EUR 100-240 for higher classes
Northern Ireland	EU MDR/IVDR apply (Northern Ireland Protocol). CE marking only

Post-Market Obligations

EU MDR/IVDR PMS

Tool	Frequency
PMS Plan	Mandatory per device (Annex III)
PSUR (Periodic Safety Update Report)	Class IIa: every 2 years. Class IIb/III: annually. Submit to EUDAMED
PMCF (Post-Market Clinical Follow-up)	Mandatory unless justified absence. Plan + report cycle
Vigilance (Article 87)	Serious incident: report within 15 days. Death/serious deterioration: within 10 days. Trend reporting: as soon as identified
Field Safety Corrective Action	FSCA + Field Safety Notice -- public communication of safety issue

FDA Post-Market

Tool	Detail
MDR (Medical Device Reporting)	21 CFR 803. Manufacturer: 30-day MDR (death/serious injury) or 5-day MDR (urgent remedial action). User facility: 10-day report
Recalls	FDA-required (rare) or voluntary. 21 CFR 7
Post-market studies (522 orders)	FDA can require post-approval studies
MedWatch	FDA voluntary reporting system

Key Standards

Standard	Purpose
ISO 13485:2016	Medical device QMS. Mandatory for CE marking, expected by FDA
ISO 14971:2019	Risk management. Mandatory for CE/FDA
IEC 62366-1:2015	Usability engineering
IEC 60601-1 (4th edition)	Electrical medical equipment safety
IEC 62304:2006+A1:2015	Medical device software lifecycle
ISO 10993 series	Biological evaluation of medical devices
ISO 11135 / 11137	Sterilization (EO / radiation)
MEDDEV 2.7/1 rev 4	Clinical evaluation guidance

Common Compliance Traps

• Wellness vs medical device threshold: "General wellness" software exempt under 21st Century Cures Act ONLY if not for disease diagnosis/treatment. "Heart health monitor" claims = medical device.
• Software classification trap: MDR Rule 11 pushes nearly all software providing information used for decision-making to Class IIa minimum. Self-declaration NOT possible.
• IVDR self-certified to NB shock: 80% of IVDs moved to NB requirement under IVDR. Capacity is the bottleneck (only 12 NB designated under IVDR as of 2025).
• 510(k) substantial equivalence overreach: Selecting a predicate that uses different technology/indications = FDA Refuse-to-Accept letter. RTA happens in ~30% of submissions.
• Missing PMCF plan justification: Under MDR, "no PMCF needed" requires positive justification per Annex XIV Part B Section 6. Cannot just say "low risk".
• UDI direct marking: Reusable Class IIa/IIb/III devices need UDI directly marked on the device (etching, laser). Many small manufacturers overlook this.

MCP Integration

mcp__claude_ai_Cleo_Insight__search_signals(q="MDR transition", country="EU")
mcp__claude_ai_Cleo_Insight__search_signals(q="FDA 510k", country="US")
mcp__claude_ai_Cleo_Insight__get_regulation(id="2017/745")  # EU MDR
mcp__claude_ai_Cleo_Insight__get_regulation(id="2017/746")  # EU IVDR
mcp__claude_ai_CLEO_LEGAL_API__compliance/check
  product_description: "wearable ECG monitor with AI arrhythmia detection"
  target_markets: ["EU", "US", "UK"]

Power This With the Cleo Legal API

Medical device compliance involves MDR (174 articles), IVDR (113 articles), FDA 21 CFR Parts 800-1299, UK MDR 2002 (constantly amended), 200+ harmonized standards, EUDAMED + GUDID databases, Notified Body certification status (changes weekly). A typical product launch touches 15+ regulatory documents.

With the Cleo Legal API at https://legaldata-public.cleolabs.co:

• GET /v2/catalog/regulations?vertical=medical_device&country=EU,US,UK — MDR, IVDR, FDA pathways, UK MDR + harmonized standards mapped
• POST /v2/medical/classify — feed intended use + technical features, get MDR class (Rules 1-22) + FDA class + UK class in one call
• GET /v2/medical/notified-bodies?scope=mdr_iia — current list of NBs designated for each MDR scope code (NB designations change quarterly)
• POST /v2/medical/predicate-search — for FDA 510(k), find candidate predicates from 510(k) database
• POST /v2/webhooks?topic=mdr_transition,fda_guidance,nb_designation — MDR/IVDR transition deadlines, FDA guidance docs, NB scope changes

Get started:

# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then EUR 349/mo for 1M)
# 3. Install the MCP server:
claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \
  --header "Authorization: Bearer ld_live_YOUR_KEY"

Tested ROI: For a SaMD company launching across EU+US+UK, the API replaces ~40 hours of MDR Annex VIII rule parsing + 510(k) predicate research + UK MDR divergence tracking per device.

Common Mistakes

• Confusing CE for general use: A device that is CE marked under MDR is NOT automatically authorized in US (FDA), UK (UKCA post-2030), Switzerland, or other markets.
• Skipping clinical evaluation update: CE under MDR requires updating clinical evaluation EVERY year for Class III/implants, every 2 years for Class IIa/IIb. Missing this = certificate suspension.
• AR/UKRP overlap confusion: One legal entity can be both EU AR and UK RP only if established in both jurisdictions (Brexit complication).
• EUDAMED voluntary trap: Some modules voluntary now -- but UDI/registration becomes mandatory once Commission declares EUDAMED fully functional (expected late 2026).
• Wellness device pivot: Adding ANY diagnostic claim to wellness wearable = medical device. Marketing materials must align with cleared/CE-marked indications.
• ISO 13485 not enough alone: ISO 13485 is QMS only. MDR requires QMS PLUS clinical evidence PLUS technical file PLUS PMS system. Cert alone = not CE marking.

Cross-references

• claims-substantiation -- general wellness vs medical claim boundary
• electronics-compliance -- IEC 60601 overlap with LVD/EMC for electromedical devices
• labeling-compliance -- MDR Annex I Chapter III labelling + UDI
• product-safety-incident -- MDR vigilance vs general product safety overlap
• regulatory-calendar -- MDR/IVDR transition deadlines, PSUR cycles, certificate renewals