Device Description & Specification

MDR Reference: Annex II, Section 1
BPG Rev.4 Reference: Section 1 (pp. 12-18)
Document Code: AII-S1
Responsible Party: Manufacturer (Client)
Service Mode: Assist

Requirements Checklist

1.1(a) Product Description & Intended Purpose

• [ ] Product or trade name and general description of the device
• [ ] Intended purpose per MDR Article 2(12)
• [ ] Intended users (physicians, surgeons, lay-persons, etc.)
• [ ] Applicable EMDN codes (per MDCG 2021-12)
• [ ] Single-use / multiple-use / reprocessing indication and cycle count
• [ ] Applicable MDA/MDN/MDS/MDT code per (EU) 2017/2185
• [ ] Use specification per EN 62366-1 clause 5.1: intended medical indication, intended patient population, intended body part/tissue, intended user profile, use environment, operating principle
• [ ] For SaMD: software versioning policy and current software version

1.1(b) Identification & UDI

• [ ] Basic UDI-DI as per Annex VI Part C
• [ ] Product code, catalogue number, or other unambiguous traceability reference
• [ ] Consistent with labelling and Declaration of Conformity

1.1(c) Patient Population & Medical Conditions

• [ ] Intended patient population (age groups, weight range, health status)
• [ ] Medical conditions to be diagnosed, treated, and/or monitored
• [ ] Patient selection criteria, indications, contra-indications, warnings
• [ ] Intended conditions of use (environment, frequency, location, mobility)

1.1(d) Principles of Operation

• [ ] Detailed explanation of device function (physics, chemistry, mechanics, biodegradation)
• [ ] Scientific demonstration where necessary (referencing design V&V, pre-clinical/clinical studies)
• [ ] Mode of action description

1.1(e) Qualification as Medical Device

• [ ] Rationale for qualification as a medical device per MDR Article 2
• [ ] If Annex XVI product: explanation for non-medical purpose qualification
• [ ] Borderline product considerations (see MDCG 2022-5)

1.1(f) Classification

• [ ] Risk class determination (I, Is, Im, Ir, IIa, IIb, III)
• [ ] Applicable classification rule(s) per Annex VIII with justification for each
• [ ] Each potentially applicable rule listed with applicable/not-applicable justification
• [ ] For multi-component devices: classification of each component
• [ ] For SaMD: qualification and classification rationale (see MDCG 2019-11)
• [ ] For WET devices: rationale per MDCG 2020-6 and Article 52(4)/(5)
• [ ] Classification guidance reference: MDCG 2021-24

1.1(g) Novel Features

• [ ] Description of novel features (novel vs market / novel vs manufacturer's portfolio)
• [ ] Scientific evidence supporting novel features
• [ ] Impact on technical/clinical safety and performance
• [ ] If no novel features: explicit statement
• [ ] Novelty degree per EU Commission Guidance 2020/C 259/02

1.1(h) Accessories & Combination Use

• [ ] Brief description of each accessory and how used with the device
• [ ] Classification and rationale for each accessory
• [ ] TD references for accessories (file name, issue status, date)
• [ ] Indication whether accessories are packaged with device or separate
• [ ] Certificate references for already-certified accessories
• [ ] Compatibility evidence
• [ ] Non-device products intended for combination use: identification, compatibility, chemical/biological compatibility

1.1(i) Configurations & Variants

• [ ] Complete list of all configurations/variants
• [ ] Sufficient information to distinguish each variant

1.1(j) Key Functional Elements

• [ ] Parts/components description (including software per EN 62304)
• [ ] Formulation, composition, functionality
• [ ] Labelled pictorial representations (diagrams, photographs, drawings)
• [ ] For active devices: electrical circuit diagrams
• [ ] Qualitative and quantitative material composition
• [ ] Critical specifications including tolerances, critical-to-quality aspects
• [ ] Critical dimensions and critical components/ingredients list
• [ ] For software: decomposition into systems, items, units per safety class

1.1(k) Raw Materials

• [ ] Bill of Materials (BOM) with CAS numbers for substances
• [ ] Raw materials in key functional elements
• [ ] Nature of contact with human body (direct/indirect/circulating fluids)
• [ ] Coatings critical for safety and performance
• [ ] Human or animal-based products identification
• [ ] Nanomaterials identification
• [ ] Packaging materials (primary and secondary)

1.1(l) Technical Specifications

• [ ] Features, dimensions, and performance attributes
• [ ] Specifications for all variants/configurations and accessories
• [ ] Indication of which specifications appear in user-facing product literature

1.2 Previous Generations & Similar Devices

• [ ] Market history of previous generation(s) with timing of changes
• [ ] If new device: explicit statement of no prior marketing
• [ ] EU and international market approvals, sales volumes per country
• [ ] Previous NB assessment references (if applicable)
• [ ] For MDD-to-MDR transition: confirmation and description of changes
• [ ] Overview of similar devices per MDR Article 2(7) and MDCG 2020-5
• [ ] Comparison showing similarities and differences vs similar devices
• [ ] Alignment of similar devices with clinical evaluation and PMCF plan

Key Regulatory References

• MDR (EU) 2017/745, Annex II, Section 1
• MDR (EU) 2017/745, Annex VIII: Classification rules
• MDCG 2021-24: Classification of medical devices
• MDCG 2020-5: Equivalence (similar device identification)
• MDCG 2020-6: Clinical evaluation -- Sufficient clinical evidence
• MDCG 2022-5: Borderline products
• MDCG 2019-11: Software qualification and classification
• EN 62366-1:2015+A1:2020: Usability engineering (use specification)
• EN 62304: Medical device software lifecycle processes
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 1

Common Pitfalls (from BPG Rev.4)

• Inconsistencies across documentation (abbreviations in DoC vs full names in labelling)
• Classification rationales lacking sufficient detail
• Contraindications not covering anatomy or populations unsupported by evidence
• Variants/configurations unclear or inconsistent throughout the TD

Dependency

This document is a Phase 1 deliverable and is the foundation for most subsequent documents. The Device Description must be aligned with IFU and established before clinical evaluation planning begins.