MDR 2017/745 Technical Documentation Submission Template

📋 How to Use This Template This template mirrors Annex II and Annex III of MDR (EU) 2017/745, structured to align with Team-NB Best Practice Guidance V3 (April 2025).

Complete all fields marked ★ REQUIRED — justification needed if marked N/A
Content type is indicated by colour badges: DOCUMENT REPORT PLAN CHECKLIST
Agree folder structure and naming convention with your Notified Body (NB) before final submission
Ensure ALL information is consistent across all documents (product name, intended use, UDI-DI, etc.)
Submit only complete, final (non-draft) documents — no abbreviated or partial reports

📑 Table of Contents

Pre-Submission Checklist ANNEX II — Technical Documentation Section 1 — Device Description & Specification 1.1 Device Description and Specification 1.2 Reference to Previous / Similar Generations Section 2 — Information Supplied by Manufacturer Section 3 — Design & Manufacturing Information Section 4 — General Safety & Performance Requirements (GSPRs) Section 5 — Benefit-Risk Analysis & Risk Management Section 6 — Product Verification & Validation 6.1 Pre-clinical & Clinical Data 6.2 Devices with Special Materials 6.3 Clinical Evaluation ANNEX III — Post-Market Surveillance Technical Documentation 7.1 Post-Market Surveillance (PMS) Plan 7.2 Periodic Safety Update Report (PSUR) Document Index / Submission Master List

🔲 Pre-Submission Checklist

Complete all actions before lodging your application with the Notified Body. Failure to complete these steps is the leading cause of delays.

Action	Reference	Status
Contact NB for pre-application dialogue — confirm language requirements	MDR Art. 52(12); MDCG 2019-6 §I.6.3	☐ Done ☐ N/A
Agree documentation folder structure and labelling convention with NB	Team-NB BPG §General Considerations	☐ Done ☐ N/A
Agree electronic submission method / portal with NB	MDCG 2019-6	☐ Done ☐ N/A
Confirm device classification (Class I / IIa / IIb / III) with NB	MDR Annex VIII	☐ Done ☐ N/A
If leveraging prior MDD/MDR assessment: reference previous NB review ID / project number; indicate what has/has not changed	Team-NB BPG §Leveraging Evidence	☐ Done ☐ N/A
Prepare complete index / Table of Contents with hyperlinks to all documents	MDR Annex II	☐ Done ☐ N/A
Verify all documents are final, complete, and signed — not draft, abbreviated, or amended	Team-NB BPG	☐ Done ☐ N/A
Verify product name / intended use / UDI-DI are consistent across ALL TD documents	Team-NB BPG §1	☐ Done ☐ N/A
Verify all data in TD matches data in application forms	Team-NB BPG	☐ Done ☐ N/A
Confirm quality of all translations (poor translations cause delays or negative recommendation)	Team-NB BPG	☐ Done ☐ N/A
Confirm harmonised standards used are SOTA (current versions); if not, prepare gap analysis	Team-NB BPG	☐ Done ☐ N/A
Confirm all V&V reports link back to specific risk controls in the risk assessment	Team-NB BPG	☐ Done ☐ N/A

⚠️ Top Causes of NB Submission Delays (Team-NB BPG)

Incomplete or inconsistent device descriptions across variants, accessories, and combined devices
Incomplete mapping of all devices under the Basic UDI-DI
Information present but difficult to locate (no index, poor structure)
Draft, abbreviated, or partial documents submitted
GSPR checklist is a list of test reports only — without demonstrating compliance logic
Duplicated information (intended use, warnings, UDI-DI) inconsistent across documents

Section 1 — Device Description & Specification, Including Variants, Accessories, Classification & Materials

1.1 Device Description and Specification DOCUMENT

(a) Product / Trade Name & General Description

Field	Content Required	Guidance / Reference
Product / Trade Name ★	[Enter exact product/trade name as it appears on labelling, DoC, and application form]	Must be identical across ALL TD documents — explain any variations in writing
Intended Purpose / Intended Use ★	[State the specific medical purpose, target patient population, target tissue/body site, conditions and duration of use, user profile (lay / professional / both)]	Must match labelling and IFU verbatim. Consistent throughout ALL evidentiary documents.
Intended Users ★	[Healthcare professional / Lay user / Both — specify any required training, expertise, or qualifications]	Links to Usability (§6.1.6)
EMDN Codes ★	[Applicable EMDN code(s) per MDCG 2021-12. Format: 1 letter + 9 digits, e.g., P0901010101]	Per MDCG 2021-12
MDA / MDN / MDS / MDT Code ★	[Applicable code(s) per Commission Regulation (EU) 2017/2185]	Per (EU) 2017/2185
Use Pattern ★	[☐ Single use only ☐ Multiple use ☐ Reprocessable — if reprocessable: state maximum number of reprocessing cycles]	Reprocessing instructions → §6.2.7
Device Classification ★	[Class: ☐ I ☐ IIa ☐ IIb ☐ III \| MDR Annex VIII Rule applied: Rule ___ \| Justification: ___]	MDR Annex VIII

(b) Design, Packaging & Sterilisation Description

Field	Content Required	Guidance / Reference
Design Description ★	[Describe device design, key components, materials of construction, physical form, dimensions, colour coding. Include labelled schematic drawings / photographs]	Must enable understanding of design, packaging, sterilisation, and characteristics
Principle of Operation / Mode of Action ★	[Describe mechanism by which device achieves its intended purpose (mechanical, electrical, biological, chemical, etc.)]
Packaging Description ★	[Describe primary sterile barrier, secondary packaging, and shipping packaging. State sterile barrier system type (e.g., peel pouch, Tyvek, blister)]	→ Packaging validation: §6.1.4
Sterilisation Method (if applicable)	[☐ ETO ☐ Gamma radiation ☐ E-beam ☐ Steam (autoclave) ☐ Dry heat ☐ Supplied non-sterile (user-sterilised) ☐ N/A — describe method and SAL target (typically SAL ≤ 10⁻⁶)]	→ Sterilisation validation: §6.2.7
Materials of Construction ★	[List all materials in contact with patient / user, internal structural materials. Include trade names + chemical names + CAS numbers where applicable]	→ Biocompatibility: §6.1.1 → Hazardous substances: §6.2.6

(c) Variants, Accessories & Device Family

Field	Content Required	Guidance / Reference
Device Variants ★	[List ALL variants (e.g., sizes, colours, lengths, power settings). For each variant: model number, description of difference from base model, impact on safety/performance]	Common pitfall: incomplete variant listing
Accessories ★	[List all accessories CE-marked for use with this device: name, model, intended purpose of accessory, manufacturer (if different)]
Basic UDI-DI ★	[Enter Basic UDI-DI and confirm ALL variants/accessories covered under this Basic UDI-DI are listed above and included in the scope of this TD]	Common pitfall: incomplete mapping to Basic UDI-DI
Device-Specific UDI-DI(s) ★	[Table of all Device Identifier (UDI-DI) codes per variant/configuration, with reference numbers and EUDAMED registration status]
Combined Devices (if applicable)	[If device is combined with another device, medicinal product, or human/animal tissue: describe each component, their respective roles, and how the combination is assessed]	→ §6.2 for biological materials; → §6.2.1 for drug-device combinations

(d) Performance Specifications

Field	Content Required	Guidance / Reference
Technical Specifications / Performance Specifications ★	[State all technical parameters relevant to safety and performance: dimensions, tolerances, electrical specifications, output energy levels, accuracy specifications, software version(s), etc.]	→ V&V: §6.1.5
Shelf Life / Expected Service Life ★	[State claimed shelf life (sterile shelf life, if applicable) and expected service life. State conditions under which these are valid (temperature, humidity, storage requirements)]	→ Stability validation: §6.1.4

⚠️ Common Pitfalls — Section 1

Product name / intended use differs across CER, GSPR checklist, labelling, or DoC without explanation
Incomplete listing of variants — not all covered under the Basic UDI-DI are described
EMDN codes missing or misaligned with MDCG 2021-12
Materials list incomplete — missing CAS numbers or contact status not identified

1.2 Reference to Previous or Similar Device Generations DOCUMENT

Field	Content Required	Guidance / Reference
Previous Generations	[List any previous generation(s) of the same device: model name, changes introduced, clinical rationale for changes, and whether the previous generation is still on the market]	Required if equivalence approach used in CER (§6.3)
Equivalent / Similar Devices	[List competitor or own-manufacturer devices used for equivalence or comparison in clinical evaluation. State basis of equivalence per MDR Art. 61(5) and MDCG 2020-5]	MDCG 2020-5; → CER: §6.3.3
Prior MDD/MDR Assessment Reference	[If this device was previously assessed under MDD or MDR: NB name, review/certificate number, date, and a clear description of what has and has NOT changed since that assessment]	Team-NB BPG §Leveraging Evidence. Must indicate extent of changes per each evidence section.

Section 2 — Information to be Supplied by the Manufacturer (Labelling & IFU) DOCUMENT

Item	Content Required	Reference
Declaration of Conformity (DoC) ★	[Complete DoC per MDR Annex IV — signed, dated, includes all devices in scope, applicable GSPRs declared, standards listed. Must be consistent with GSPR checklist (§4)]	MDR Annex IV; Art. 19
Label(s) — All Variants ★	[Provide all label versions (primary, secondary, shipping) for all variants. Labels must comply with MDR Annex I GSPR 23 and include all mandatory UDI, CE mark with NB number, manufacturer info, symbols per ISO 15223-1, expiry date, lot/serial, storage conditions, sterile indicator if applicable]	MDR Annex I GSPR 23; ISO 15223-1
Instructions for Use (IFU) ★	[Complete IFU for all language versions required. IFU must comply with MDR Annex I GSPR 23.4. Content: intended use, contraindications, warnings, precautions, instructions for preparation/use/disposal, side effects, storage conditions, shelf life, symbols legend]	MDR Annex I GSPR 23.4; ISO 15223-1
e-IFU (Electronic IFU) ★ (if applicable)	[If IFU is provided electronically: confirm compliance with Regulation (EU) 2021/2226. Provide URL where e-IFU is accessible (must be live and stable). State how IFU is provided upon request in paper format]	EU Regulation 2021/2226; MDR Annex I GSPR 23.1
URL for IFU / Device Information Website	[If applicable under MDR Annex I GSPR 23.1: provide the stable URL referenced on the label. Confirm it is accessible and functional]	MDR Annex I GSPR 23.1
Patient Handbook / Card (if applicable)	[For implantable devices: provide implant card per MDR Art. 18. For devices intended for lay use: provide patient information/handbook]	MDR Art. 18
Physician Handbook / Training Materials (if applicable)	[Provide any physician or HCP training guides, surgical technique guides, or training requirement descriptions]
Promotional / Marketing Materials (if applicable)	[Provide samples of any promotional materials that make CE-marking or clinical performance claims. Confirm all claims are consistent with IFU and CER conclusions]	Claims must be substantiated in CER (§6.3)

⚠️ Common Pitfalls — Section 2

Intended use or device description on label/IFU differs from TD without explanation
Missing mandatory UDI-DI on label
IFU not available in all required languages
e-IFU URL is broken, under construction, or returns a 404
Promotional claims not substantiated by clinical evidence in the CER

Section 3 — Design & Manufacturing Information DOCUMENT

Field	Content Required	Reference
Manufacturer — Legal Manufacturer ★	[Full legal name, registered address, contact details, EU-registered place of business. EUDAMED SRN. EU Authorised Representative (if manufacturer outside EU): name, address, SRN]	MDR Art. 11; Art. 13
Design Sites ★	[List all sites responsible for design activities. For each: company name, address, description of design activities performed at that site, ISO 13485 cert reference]
Manufacturing Sites ★	[List all manufacturing sites (including subcontractors, OEM suppliers). For each: company name, address, activities performed, ISO 13485 cert reference or equivalent QMS evidence. State if site is approved by a regulatory authority (e.g., FDA establishment registration)]	MDR Annex II §3.1
Critical Suppliers / Subcontractors ★	[List all critical component suppliers / subcontractors. For each: company name, address, component or process supplied, basis for criticality determination, supplier control mechanism (e.g., audit frequency, approval status)]
Manufacturing Process Description ★	[Provide a high-level flow chart and narrative description of the manufacturing process from raw materials to finished device, including key process steps, in-process controls, and critical process parameters]
Quality Management System ★	[Provide ISO 13485 certificate(s) covering all design/manufacturing activities in scope. Certificate(s) must be current (valid), cover the specific device, and reference the correct sites]	MDR Art. 10(9); MDR Annex IX
Sterilisation Sites / Process (if applicable)	[Identify sterilisation site(s). Provide process description, method, and reference to sterilisation validation report (→ §6.2.7)]	→ §6.2.7

Section 4 — General Safety & Performance Requirements (GSPRs) CHECKLIST

📘 GSPR Compliance Approach — Critical Requirements

The GSPR checklist must address EVERY applicable GSPR in MDR Annex I — not just those for which test reports exist
For each GSPR: state (1) whether applicable, (2) the method of demonstrating compliance, (3) the specific document / standard / test / justification used
Simply listing test reports is NOT sufficient — demonstrate the compliance logic
Use current (SOTA) versions of harmonised standards; if a non-current version is used, provide a gap analysis
If GSPR is Not Applicable (N/A): provide an explicit, documented justification

GSPR #	Requirement	Applicable?	Method of Compliance / Document Reference	Standard / Reference
1	General safety & performance — do no harm	☐ Y ☐ N/A	[Describe / reference]
2	Acceptability of risks — risk/benefit balance	☐ Y ☐ N/A	[Describe / reference]	ISO 14971
3	Performance characteristics — known side effects	☐ Y ☐ N/A	[Describe / reference]
4	Characteristics of devices intended for lay users	☐ Y ☐ N/A	[Describe / reference]	IEC 62366-1
5	Devices intended to be combined with other devices	☐ Y ☐ N/A	[Describe / reference]
6	Chemical, physical, biological properties	☐ Y ☐ N/A	[Describe / reference]	ISO 10993 series
7	Infection and microbial contamination — sterility	☐ Y ☐ N/A	[Describe / reference]	ISO 11135/11137/13485
8	Devices incorporating medicinal substances	☐ Y ☐ N/A	[Describe / reference]
9	Devices incorporating materials of animal/human origin	☐ Y ☐ N/A	[Describe / reference]
10	Devices incorporating a substance considered a medicinal product	☐ Y ☐ N/A	[Describe / reference]
11	Devices interacting with environment (energy)	☐ Y ☐ N/A	[Describe / reference]	IEC 60601 series
12	Devices with a diagnostic or measuring function	☐ Y ☐ N/A	[Describe / reference]
13	Radiation protection	☐ Y ☐ N/A	[Describe / reference]	IEC 60601-1-3
14	Software requirements (MDSW / SaMD / SIMD)	☐ Y ☐ N/A	[Describe / reference]	IEC 62304; MDCG 2019-16
15	Active devices — electrical & mechanical requirements	☐ Y ☐ N/A	[Describe / reference]	IEC 60601-1
16	Protection against mechanical risks	☐ Y ☐ N/A	[Describe / reference]
17	Devices delivering substances to patients	☐ Y ☐ N/A	[Describe / reference]
18	Active implantable devices	☐ Y ☐ N/A	[Describe / reference]
19	Specific requirements for active implantable devices	☐ Y ☐ N/A	[Describe / reference]
20	Protection against risks from external energy sources	☐ Y ☐ N/A	[Describe / reference]
21	Protection against risks posed to patients using implantable devices	☐ Y ☐ N/A	[Describe / reference]
22	Reprocessing — reusable surgical instruments	☐ Y ☐ N/A	[Describe / reference]	ISO 17664
23	Labelling requirements — information supplied by manufacturer	☐ Y ☐ N/A	[Describe / reference]	MDR Annex I §23; ISO 15223-1

⚠️ Common Pitfalls — Section 4

GSPR checklist is a list of test reports only — without explaining HOW each report demonstrates compliance to each GSPR
Non-SOTA standard versions used without gap analysis or justification
GSPRs marked N/A without documented justification
GSPR checklist inconsistent with DoC — different standards listed

Section 5 — Benefit-Risk Analysis & Risk Management

5.1 Risk Management Plan PLAN

Field	Content Required	Reference
Scope of Risk Management ★	[Define scope: which device(s), phases of lifecycle covered (design, manufacture, post-market). State that scope is not limited to risks listed in any specific section — all foreseeable hazards must be included]	ISO 14971:2019 §4.3
Risk Acceptability Criteria ★	[State risk policy: criteria for determining acceptable vs. unacceptable risk. Describe risk evaluation matrix (probability x severity). Reference clinical and safety data used to define acceptability]	ISO 14971:2019 §4.4
Intended Use Characterisation ★	[Document intended use, intended users, environment of use, patient population, and foreseeable misuse per ISO 14971 Annex C]	ISO 14971:2019; ISO/TR 24971
Residual Risk Policy ★	[State policy for evaluation of overall residual risk. Confirm benefit-risk balance evaluation approach]	ISO 14971:2019 §9

5.2 Risk Analysis & Risk Control Measures REPORT

Field	Content Required	Reference
Hazard Identification ★	[Systematic identification of all hazards and hazardous situations — energy hazards, biological hazards, use errors, software hazards, environmental hazards, etc.]	ISO 14971:2019 §5; ISO/TR 24971 Annex A
Risk Estimation & Evaluation ★	[For each harm: estimate probability of occurrence and severity; evaluate risk acceptability per defined criteria]	ISO 14971:2019 §§5–6
Risk Control Measures ★	[Document all risk control measures applied (inherent safety by design → protective measures → information for safety). Confirm hierarchy of controls applied per ISO 14971 §7]	ISO 14971:2019 §7
V&V Linkage ★	[CRITICAL: Each risk control measure must be linked to a specific verification or validation activity. Provide cross-reference table: Risk → Control Measure → V&V Protocol/Report reference]	Team-NB BPG — mandatory linkage

5.3 Scope of Risk Analysis

📘 Guidance The scope of risk analysis is NOT limited to a fixed list. It must include ALL foreseeable risks associated with the device across its entire lifecycle, including: energy hazards, biological hazards, use errors, software/algorithm risks, environmental degradation, combination risks (when used with other devices), risks from abnormal operation, risks from maintenance/reprocessing.

5.4 Risk Management Report REPORT

Field	Content Required	Reference
Risk Management Report ★	[Complete RMR summarising: all identified hazards, residual risks after controls, confirmation all risks are ALARP, overall residual risk evaluated as acceptable. Must be signed and dated by authorised person]	ISO 14971:2019 §9
Benefit-Risk Analysis ★	[Document benefit-risk analysis: describe clinical benefits, quantify where possible, compare against residual risks. Conclusion must be explicit: benefits outweigh residual risks]	MDR Annex I §1; ISO 14971:2019 §9

⚠️ Common Pitfalls — Section 5

Risk analysis incomplete — not all hazards identified (e.g., software hazards, use errors, combination risks omitted)
V&V reports not cross-referenced to specific risk controls
Risk management report not updated after design changes
Benefit-risk analysis conclusion not explicit

Section 6 — Product Verification & Validation

6.1 Pre-Clinical & Clinical Data

6.1.1 Biocompatibility REPORT

Field	Content Required	Reference
Biological Evaluation Plan (BEP) ★	[BEP per ISO 10993-1 identifying all patient-contact materials, nature and duration of contact, biological risks to be evaluated, and testing/justification strategy]	ISO 10993-1; MDCG 2020-18
Material Characterisation ★	[Chemical characterisation of all patient-contact materials per ISO 10993-18. Include chemical analysis results, SOUP assessment, CAS numbers]	ISO 10993-18
Biological Evaluation Report (BER) ★	[Complete BER per ISO 10993-1 with test results or literature-based justifications for all identified biocompatibility endpoints: cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation (if applicable), haemocompatibility (if blood contact), chronic toxicity/carcinogenicity (if long-term contact)]	ISO 10993 series
Toxicological Risk Assessment (TRA)	[TRA per ISO 10993-17 for any chemical substances identified through characterisation. Include Tolerable Intake (TI) calculations, exposure estimates, and risk conclusions]	ISO 10993-17

6.1.2 Software & Software Validation (incl. Cybersecurity) DOCUMENT

Field	Content Required	Reference
Software Description (SOUP list) ★	[Describe software architecture, software safety class (per IEC 62304 A/B/C), list of all SOUP components with version numbers and their safety classification]	IEC 62304; MDCG 2019-16
Software Development Lifecycle (SDLC) documentation ★	[Software Development Plan, Software Architecture, Software Design Specifications, Software Verification & Validation reports, Software Release documentation]	IEC 62304
Cybersecurity Documentation ★	[Threat model, security risk assessment, security testing results (penetration testing, vulnerability scanning), cybersecurity plan for lifecycle, disclosure/patching policy]	MDCG 2019-16; IEC 81001-5-1
Algorithm Performance (if AI/ML or diagnostic algorithm)	[For AI/ML-enabled devices: training/validation/test dataset description, algorithm performance metrics (sensitivity, specificity, AUC, etc.), generalisability analysis, bias assessment]	MDCG 2019-16; ISO/IEC 42001
SaMD Qualification (if applicable)	[Confirm SaMD qualification per MDCG 2019-11 and state intended medical purpose and severity of condition addressed]	MDCG 2019-11

6.1.3 Electrical Safety & EMC REPORT

Field	Content Required	Reference
Electrical Safety Test Report ★ (if active device)	[Test report to IEC 60601-1 (general) and applicable collateral/particular standards. Must be by accredited test lab. Confirm test specimen represents final device version]	IEC 60601-1 and collaterals
EMC Test Report ★ (if active device)	[EMC test report to IEC 60601-1-2. Include emissions and immunity testing. Specify frequency bands, test configurations, pass/fail criteria and results]	IEC 60601-1-2
MR Compatibility / Safety (if applicable)	[For devices used in MRI environment: MR Conditional/Safe/Unsafe classification per ASTM F2503. Provide supporting test reports (static field, RF, gradient field testing)]	ASTM F2503; ISO/TS 10974

6.1.4 Packaging, Stability & Shelf-Life REPORT

Field	Content Required	Reference
Packaging Validation ★	[Packaging validation report per ISO 11607 Parts 1 and 2. Include seal strength testing, microbial barrier testing, accelerated ageing protocol, and visual inspection results]	ISO 11607-1; ISO 11607-2
Shelf Life / Stability Study ★	[Real-time and/or accelerated ageing study results. State shelf life claimed, ageing protocol (temperature/humidity conditions), and physical/chemical/biological end-points tested. State Q10 factor used if accelerated ageing]	ASTM F1980; ISO 11607
Transport Validation	[Distribution cycle testing / transport validation report demonstrating device survives distribution conditions without degradation]	ASTM D4169; ISTA protocols

6.1.5 Performance & Safety — Design V&V REPORT

Field	Content Required	Reference
Design Verification Reports ★	[All design verification test reports demonstrating device meets design specifications. Must be final, complete, signed reports — not reports subsequently amended as device changed. Include: OQ/PQ records, dimensional verification, mechanical testing (tensile, compressive, fatigue, burst, etc.)]	ISO 13485 §7.3
Design Validation Reports ★	[Validation reports demonstrating device meets user needs and intended use under actual or simulated conditions of use. Include: simulated use studies, clinical simulation, bench-to-bedside testing]	ISO 13485 §7.3
Measuring/Diagnostic Function Verification (if applicable)	[For devices with a measuring function: accuracy, precision, linearity, limit of detection, reproducibility verification per applicable standard. Include traceability to SI units where applicable]	MDR Annex I GSPR 12; ISO/IEC 17511
Process Validation (special processes) ★	[IQ/OQ/PQ validation records for all special processes (welding, moulding, bonding, sterilisation, etc.) where output cannot be fully verified by inspection]	ISO 13485 §7.5.6
Compatibility Testing (if combined with other devices)	[Testing demonstrating safe and effective use when combined with other intended devices, including worst-case configurations]	MDR Annex I GSPR 5

6.1.6 Usability REPORT

Field	Content Required	Reference
Usability Engineering File ★	[Complete usability engineering file per IEC 62366-1: user interface specification, use specification, use errors analysis, formative evaluation results, summative validation study report (summative usability test with representative users under simulated conditions)]	IEC 62366-1; IEC 62366-2
Risk Controls from Usability Engineering ★	[Document use-error related risks identified, link to risk management file (§5.2), and demonstrate residual use-error risks are acceptable]	IEC 62366-1; ISO 14971

6.2 Devices with Special Materials

6.2.1 Drug / Device Combination Products DOCUMENT

Field	Content Required	Reference
Medicinal Substance Assessment ★	[If device incorporates a medicinal substance as an integral part: provide full pharmaceutical assessment of the substance, evidence it has ancillary action, justification that benefit/risk is acceptable. For Class III devices: provide EMA consultation outcome or procedure reference]	MDR Art. 117; MDR Annex IX §5.2; Directive 2001/83/EC
CoA for Medicinal Substance	[Certificate of Analysis for the incorporated medicinal substance showing identity, purity, and potency]

6.2.2–6.2.4 Human / Animal / Biological Origin Matter DOCUMENT

Field	Content Required	Reference
Materials of Human/Animal Origin ★	[Identify source, processing, testing, and viral inactivation measures. For animal-derived materials: species, tissue type, country of origin, TSE risk assessment. For human-derived: donation/consent procedures, pathogen testing]	MDR Annex I GSPR 9; EC 722/2012 (animal); EC 2016/1214 (human)
TSE/BSE Risk Assessment (animal origin)	[Transmissible Spongiform Encephalopathy risk assessment and mitigation measures per EC 722/2012]	EC 722/2012

6.2.5 Substances Absorbed or Locally Dispersed DOCUMENT

Field	Content Required	Reference
Absorption / Dispersion Assessment ★	[For devices that release or absorb substances: characterisation of the substance, quantity released/absorbed, local and systemic toxicological risk assessment]	MDR Annex I GSPR 6.4; ISO 10993-17

6.2.6 Hazardous Substances — CMR & Endocrine Disruptors DOCUMENT

Field	Content Required	Reference
CMR / Endocrine Disruptor Assessment ★	[Screen all materials for CMR (Carcinogenic, Mutagenic, Reprotoxic) substances and endocrine disruptors per MDR Annex I GSPR 10.4. For each identified substance: concentration, route of exposure, TRA conclusion, justification that use is justified or unavoidable, statement on alternatives considered]	MDR Annex I GSPR 10.4; REACH Regulation; ISO 10993-17
Phthalates / DEHP Assessment (if applicable)	[If device contains DEHP or other restricted phthalates and is intended for vulnerable patient populations: enhanced justification and clinical risk assessment required]	MDR Annex I GSPR 10.4.2

6.2.7 Sterilisation & Reusable Surgical Instruments REPORT

Field	Content Required	Reference
Sterilisation Validation Report ★	[Complete sterilisation validation report: IQ/OQ/PQ for the sterilisation process, SAL demonstration (≤10⁻⁶), bio-burden data, dose-setting/dose-audit records (for radiation), cycle development records (for ETO/steam). Must reference final device configuration]	ISO 11135 (ETO); ISO 11137 (radiation); ISO 17665 (steam); ISO 13485
Reprocessing Instructions & Validation (reusable instruments)	[For reusable instruments: validated cleaning, disinfection, and sterilisation instructions. Include: cleaning validation (protein residue, microbiological), compatibility with specified reprocessing agents, maximum number of cycles and end-of-life criteria]	ISO 17664; ISO 15883; MDCG 2022-6

6.3 Clinical Evaluation

6.3.1 Clinical Evaluation Strategy PLAN

Field	Content Required	Reference
Clinical Evaluation Strategy Document ★	[High-level document outlining the overall clinical evaluation strategy: equivalence vs. clinical investigation data; scope of literature review; planned clinical investigations; justification of approach for the device's risk class]	MDR Art. 61; MDCG 2020-6; MDCG 2020-5
Equivalence Justification (if used)	[If clinical evidence is based on equivalence to another device: detailed clinical, technical, and biological equivalence justification per MDCG 2020-5. For Class III / Class IIb implantables: contractual access to equivalent device's TD required]	MDR Art. 61(5); MDCG 2020-5
Common Specifications (CS) Compliance (if applicable)	[If a Common Specification exists for the device: state whether CS is complied with, or provide equivalent safety/performance justification]	Applicable CS per device type

6.3.2 Clinical Evaluation Plan (CEP) PLAN

Field	Content Required	Reference
CEP ★	[Complete CEP per MDCG 2020-6 including: scope of CEP (device, intended use, target population, intended users), SOTA definition, clinical outcomes (safety, performance endpoints), clinical claims to be substantiated, acceptance criteria for clinical data, search strategy for literature, criteria for inclusion/exclusion of clinical data, timeline]	MDR Annex XIV; MDCG 2020-6; MDCG 2020-5
SOTA Definition ★	[Define the current state of the art (SOTA) for this device type / indication, including available alternative treatments, expected clinical performance benchmarks, and safety benchmarks]	MDR Annex I GSPR 1; MDCG 2020-6
Search Strategy Documentation ★	[Literature databases searched (PubMed, EMBASE, Cochrane, etc.), search terms, date range, inclusion/exclusion criteria. Must be reproducible]	MDCG 2020-6; PRISMA guidelines

6.3.3 Clinical Evaluation Report (CER) REPORT

Field	Content Required	Reference
CER ★	[Complete CER authored by qualified clinical evaluator(s) per MDCG 2020-1. Must include: device description, intended use, clinical background/SOTA, systematic literature search results (literature appraisal tables), clinical data summary, benefit-risk determination based on clinical data, conclusion on clinical safety and performance, outstanding issues/gaps for PMCF]	MDR Art. 61; MDR Annex XIV; MDCG 2020-6; MDCG 2020-1
Clinical Evaluator CV(s) ★	[CV(s) of clinical evaluator(s) demonstrating expertise: minimum 10 years clinical/scientific experience in the device field, relevant publications, no disqualifying conflicts of interest]	MDCG 2020-1
Literature Appraisal Tables ★	[For each included study: citation, study type, patient population, device used, outcomes reported (safety + performance), risk-of-bias/quality score, contribution to the clinical evaluation]	MDCG 2020-6 Appendix
Clinical Investigation Reports (if applicable)	[For devices requiring clinical investigation per MDR Art. 61(4): full Clinical Investigation Report per ISO 14155 and MDCG 2021-6. Include SAP, protocol, CSR, all data listings]	MDR Art. 62–82; ISO 14155; MDCG 2021-6
CECP Outcome (Class III / IIb implantables)	[For Class III and Class IIb implantable devices: SCENIHR / EAPC consultation outcome under the Clinical Evaluation Consultation Procedure (CECP) per MDR Art. 54]	MDR Art. 54; MDCG 2020-6
Residual Clinical Data Gaps ★	[Clearly identify any clinical data gaps, uncertainties, or limitations. State how these are addressed in the PMCF plan (§6.3.4)]	MDCG 2020-6

6.3.4 PMCF Plan & PMCF Evaluation Report PLAN REPORT

Field	Content Required	Reference
PMCF Plan ★	[Complete PMCF plan per MDCG 2020-7: rationale for PMCF activities, specific PMCF objectives (linked to CER data gaps), PMCF methods (PMCF study, patient registry, survey, literature surveillance), timelines, acceptance criteria, responsible persons]	MDR Annex XIV Part B; MDCG 2020-7
PMCF Evaluation Report (PMCFER) ★	[Complete PMCFER per MDCG 2020-8: results from PMCF activities, impact on CER conclusions, any new safety signals, conclusions and recommendations for next CER update cycle]	MDR Annex XIV Part B; MDCG 2020-8
Rationale if PMCF not conducted / survey/literature approach	[If PMCF via survey or literature surveillance only: justification per MDCG 2020-7 that this is sufficient for the device type/risk class. PMCF surveys must be prospective and statistically powered]	MDCG 2020-7

6.3.5 Summary of Safety and Clinical Performance (SSCP) DOCUMENT

📘 SSCP Applicability Required for: Class III devices and implantable devices (except Class III custom-made and investigational devices). Must be uploaded to EUDAMED and reviewed by the NB. Must be written in all EU official languages or at minimum the language(s) required per MDR Art. 32(2).

Field	Content Required	Reference
SSCP Document ★	[SSCP per MDR Art. 32 and MDCG 2019-9: device description & identification (UDI), intended use, contraindications, warnings, clinical evidence summary, residual risks, PMCF plan summary, NB name/number/opinion, revision history. Must be layered — patient-readable and professional sections]	MDR Art. 32; MDCG 2019-9
SSCP-Labelling Consistency Check ★	[Verify SSCP claims and contraindications are fully consistent with IFU labelling — conflicts flagged and resolved]	Team-NB BPG §6.3.5

7.1 Post-Market Surveillance (PMS) Plan PLAN

Field	Content Required	Reference
PMS Plan ★	[Complete PMS plan per MDR Art. 84 and MDR Annex III §1. Must include: proactive PMS methods (complaint monitoring, literature surveillance, registry data, PMCF, field safety corrective action tracking, device tracking); reactive PMS (vigilance, complaint handling, MDR Art. 87-91 reporting); defined review cycle and update triggers; responsible personnel and SOPs referenced]	MDR Art. 83–86; MDR Annex III; MDCG 2022-21
Complaint Handling System	[Describe complaint handling process: intake, investigation, regulatory reporting assessment, corrective action process, trend analysis. Reference SOP]	MDR Art. 83; ISO 13485 §8.2
Vigilance System	[Describe vigilance process: serious incident detection, assessment, reporting (15-day / 30-day / 2-day timelines per event type), field safety corrective action management, NB and competent authority reporting]	MDR Art. 87–92; MDCG 2023-3
Literature Surveillance	[Systematic literature monitoring plan: databases, search terms, frequency (at minimum annually), process for incorporating new data into CER and PSUR]	MDR Annex III §1(a); MDCG 2020-7
Registry / Real-World Data Sources	[List of any registries, real-world data sources, or surveillance databases relevant to the device. State how data from these sources feeds into the PMCF and PSUR]
PMS Report (Class I devices) / PSUR trigger	[For Class I devices: PMS Report per MDR Art. 85 (updated as needed, available on request). For Class IIa/IIb/III: PSUR per §7.2 below]	MDR Art. 85 (Class I); MDR Art. 86 (Class IIa–III)

7.2 Periodic Safety Update Report (PSUR) REPORT

📘 PSUR Frequency Requirements

Class III and implantable Class IIb: PSUR update at least annually
Class IIa and non-implantable Class IIb: PSUR update at least every 2 years
PSUR must be made available to NB upon request (Class IIa/IIb) or actively submitted (Class III / implantable IIb via EUDAMED)

Field	Content Required	Reference
PSUR ★	[Complete PSUR per MDR Art. 86 and MDCG 2022-21. Mandatory sections: (1) device identification (all variants/UDIs); (2) volume of sales / device market exposure; (3) summary of PMS data collected since last PSUR: complaints, serious incidents, field safety actions, literature surveillance results, PMCF data; (4) benefit-risk evaluation conclusion; (5) conclusions and actions taken; (6) main findings from PMCF; (7) SSCP update trigger assessment]	MDR Art. 86; MDR Annex III §2; MDCG 2022-21
Market/Sales Data	[Number of devices placed on market / put into service in reporting period, by country. Exposure data (patient-use days, procedures, implant years, etc.) to contextualise complaint/incident rates]	MDR Annex III §2
Trend Analysis	[Statistical trend analysis of complaint and incident data. Description of any trend identified, and actions taken or planned]	MDR Art. 88; MDCG 2023-3
Benefit-Risk Re-evaluation ★	[Updated benefit-risk analysis based on new PMS data. Conclusion must be explicit: device continues to show favourable benefit-risk balance. If unfavourable: describe field safety corrective actions]	MDR Annex III §2; ISO 14971
SSCP Update Trigger Assessment ★	[Assessment of whether PSUR findings require update of the SSCP (§6.3.5). If yes: provide updated SSCP with revision history]	MDR Art. 32; MDR Art. 86(2)

⚠️ Common Pitfalls — Annex III (PMS)

PMS plan is generic — not tailored to the specific device type, its risks, and known failure modes
Complaint data not linked to trend analysis or benefit-risk re-evaluation
PSUR not updated at the required frequency (Class III: annually)
SSCP not updated following significant PSUR findings
Vigilance reporting timelines not mapped to specific event types

Use this master list as your submission index / table of contents. Populate document title, version, date, and file reference for each item submitted. Include hyperlinks where possible. Submit this completed index as the first document in your TD submission.

Section	Document Title	Doc Type	Status
Pre-Sub	Pre-Application Communication Record	Record	☐ Included ☐ N/A
1.1	Device Description & Specification Document	Document	☐ Included ☐ N/A
1.2	Device History / Prior Assessment Reference	Document	☐ Included ☐ N/A
2	Declaration of Conformity (DoC)	Document	☐ Included ☐ N/A
2	Labels — All Variants (all language versions)	Document	☐ Included ☐ N/A
2	Instructions for Use (IFU) — All language versions	Document	☐ Included ☐ N/A
2	e-IFU Compliance Declaration (if applicable)	Document	☐ Included ☐ N/A
3	ISO 13485 Certificate(s) — all manufacturing sites	Certificate	☐ Included ☐ N/A
3	Manufacturing Site List & Critical Suppliers List	Document	☐ Included ☐ N/A
4	GSPR Checklist / Compliance Matrix	Checklist	☐ Included ☐ N/A
5	Risk Management Plan	Plan	☐ Included ☐ N/A
5	Risk Management Report (including Benefit-Risk Analysis)	Report	☐ Included ☐ N/A
6.1.1	Biological Evaluation Plan (BEP)	Plan	☐ Included ☐ N/A
6.1.1	Biological Evaluation Report (BER) incl. TRA	Report	☐ Included ☐ N/A
6.1.2	Software Development Lifecycle (SDLC) File	Document	☐ Included ☐ N/A
6.1.2	Cybersecurity Assessment Report	Report	☐ Included ☐ N/A
6.1.3	Electrical Safety Test Report (IEC 60601-1)	Report	☐ Included ☐ N/A
6.1.3	EMC Test Report (IEC 60601-1-2)	Report	☐ Included ☐ N/A
6.1.4	Packaging Validation Report (ISO 11607)	Report	☐ Included ☐ N/A
6.1.4	Shelf-Life / Stability Study Report	Report	☐ Included ☐ N/A
6.1.5	Design Verification & Validation Reports	Report	☐ Included ☐ N/A
6.1.6	Usability Engineering File (IEC 62366-1)	Report	☐ Included ☐ N/A
6.2.x	Special Materials Assessments (drug, biological, hazardous substances)	Report	☐ Included ☐ N/A
6.2.7	Sterilisation Validation Report	Report	☐ Included ☐ N/A
6.3.2	Clinical Evaluation Plan (CEP)	Plan	☐ Included ☐ N/A
6.3.3	Clinical Evaluation Report (CER) incl. literature appraisal tables	Report	☐ Included ☐ N/A
6.3.3	Clinical Evaluator CV(s)	CV	☐ Included ☐ N/A
6.3.4	PMCF Plan	Plan	☐ Included ☐ N/A
6.3.4	PMCF Evaluation Report (PMCFER)	Report	☐ Included ☐ N/A
6.3.5	Summary of Safety & Clinical Performance (SSCP)	Document	☐ Included ☐ N/A
7.1	Post-Market Surveillance (PMS) Plan	Plan	☐ Included ☐ N/A
7.2	Periodic Safety Update Report (PSUR)	Report	☐ Included ☐ N/A

Disclaimer: This template is based on Team-NB Best Practice Guidance V3 (April 2025) and MDR (EU) 2017/745. It is intended as a working tool for manufacturers and regulatory professionals to structure their Technical Documentation. It is not a legal document and does not substitute for consultation with your Notified Body or regulatory counsel. NB-specific requirements may differ. Always agree submission structure and language requirements with your designated NB prior to submission.

MDR (EU) 2017/745 — Technical Documentation Submission Template