TECHNICAL DOCUMENTATION STRUCTURE

PER ANNEX II OF MDR (EU) 2017/745

Clinical Evaluation Plan & Report

Usability 62366 *

The Technical Documentation shall be presented in a clear, organized, readily VALIDATION Post Market Clinical Follow Up (PMCF) Plan & Report
searchable and unambiguous manner and include the elements shown in this poster. DATA

PMS Plan & Report (see Annex III of (EU) 2017/745

6
Name, General Description, Basic UDI-DI
DESIGN
VERIFICATION V&V Performance and Safety Test Results
Intended use, claims, patients, users, conditions, & VALIDATION
contraindications, warnings SUMMARY
REPORT* Physical, Chemical & Microbiological
Characterization
Operating principles & mode of action
1
Classification including rule justification, rationale DEVICE Biocompatibility 10993-X
for classification as a device DESCRIPTION
Stability & Shelf Life
Description, configuration, variants, accessories, VERIFICATION
other devices and combinations DATA Reprocessing

Key functional elements

(parts/formulation/composition/functionality) 5 Electrical Safety & EMC 60601-X

Raw materials (of key functional elements & of

2 RISK
MANAGEMENT
Software Verification & Validation 62304

parts with indirect/direct body contact) INFORMATION

Information on test design, test protocols,
SUPPLIED data analysis methods, data summaries
Technical Specifications and test conclusions
(Features/dimensions/ performance
attributes in specs made available to user)

Previous generations & similar devices on markets

Risk Management Plan

Labels
Risk Management Methods, e.g. Preliminary Hazard
Analysis, D-FMEA, P-FMEA, FTA, HAZOP, HACCP *
IFUs 4
GENERAL SAFETY AND Risk Management Report
PERFORMANCE , including benefit- risk analysis
3 REQUIREMENTS
(GSPRS)
Design Stages applied (Design Control) DESIGN &
MANUFACTURING
Design & Manufacturing specifications

Manufacturing processes, process validations,

adjuvants & continuous monitoring
List of applied standards
Final product testing / Quality Control Plan * including Common Specifications

Site identification (All sites, suppliers, subcontractors GSPR Checklist / Matrix

with design/manufacturing actitivies)

GSPR link to verification/validation including

precise identity of evidence documents for each
harmonized standard and Common Specification

Michael Hottner
michael@straightforward-consulting.de
www.straightforward-consulting.com
* not directly required by Annex II of 2017/745, but typically
necessary to show evidence with GSPRs