Guide to Writing MDR Technical Documentation

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1

Product description and specification

Guide to Writing MDR Technical Documentation – Figure 1

1.1 Basic product information

  • Product name: including the generic name and trade name

  • Basic UDI-DI: state accurately the corresponding code in the UDI database (EUDAMED)

  • Intended patient population: clearly describe the characteristics of the target population (such as age, sex and disease state)

  • Principle of operation: explanation of the mechanism of action based on scientific principles (diagrams may be used to aid explanation)

  • Medical device status: declare the product’s qualification as a medical device under the MDR

  • Risk class: the risk class determined according to MDR Annex VIII (e.g. Class I/IIa/IIb/III)

  • Description of novel features: the core technical changes compared with previous generations (such as new materials or algorithm upgrades)

  • List of accessories: models/specifications of required and optional accessories

  • Explanation of variant differences: comparison table of performance parameters for products with multiple models (tabular format recommended)

1.2 Comparison with previous generations and similar devices

  • Previous generations: list the main technical parameters of earlier models and the improvements made

  • Similar devices: competitor analysis (comparing function, performance, market positioning and other dimensions)

Guide to Writing MDR Technical Documentation – Figure 2
2

Information supplied by the manufacturer

Guide to Writing MDR Technical Documentation – Figure 3

Labelling:

  • Sales packaging label content (meeting the requirements of MDR Article 30)

  • Transport packaging labelling (such as storage and transport conditions and warning symbols)

Instructions for use:

  • Patient instructions for use (with clear operating flowcharts)

  • Technical manual for professionals (including maintenance guidance)

3

Design and manufacturing information

Guide to Writing MDR Technical Documentation – Figure 4

Design and development process: description of the quality management system in accordance with MDR Annex II

Description of manufacturing processes: key process control points and index of validation records

Supply chain information: index of qualification documents for key raw material suppliers

Guide to Writing MDR Technical Documentation – Figure 5
4

General safety and performance requirements

Guide to Writing MDR Technical Documentation – Figure 6

Compliance with the General Safety and Performance Requirements (GSPR) in MDR Annex I Chapter II

Specific requirements: list of parameters such as electrical safety, biocompatibility and mechanical performance

5

Benefit-risk management

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Risk analysis report: FMEA results in accordance with ISO 14971

Risk control measures: prevention and contingency plans for hazardous events

Benefit assessment: benefit-risk analysis supported by clinical data

6

Product verification and validation

Guide to Writing MDR Technical Documentation – Figure 8

6.1 Pre-clinical and clinical data

  • Pre-clinical studies: summary of in vitro testing, animal studies and other data

  • Clinical data: results of clinical investigations or literature reviews in accordance with MDR Annex XIV

6.2 Additional information

  • Description of residual risks and follow-up monitoring plan

  • Cybersecurity verification report for software medical devices

Guide to Writing MDR Technical Documentation – Figure 9
Guide to Writing MDR Technical Documentation – Figure 10

END

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Guide to Writing MDR Technical Documentation – Figure 11

About Us

COMPANY INTRODUCTION
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Guide to Writing MDR Technical Documentation – Figure 12

Our Offices

COMPANY  ADDRESS
Shanghai: Room 705, Building 6, Lane 111, Luxiang Road, Baoshan District, Shanghai | Germany: Landsberger Str. 155, 80687 München, Germany
Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria
Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
Guide to Writing MDR Technical Documentation – Figure 13
Guide to Writing MDR Technical Documentation – Figure 14




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