Hitec Medical MDR training Technical Documentation Requirements under MDR Part 1

Elements

Content

Device description, included software and accessories

General description of the product, including intended use and intended users; UDI; indications and contraindications; instructions for use; user requirements; product classification; model list; material description; and performance indicators.

Information provided by the manufacturer

Labels on products and their packaging, instructions for use. (Use a language acceptable to the Member State where the device is intended for sale)

Design and manufacturing information

Complete information and specifications for understanding the design phase of the device, the manufacturing process and its validation, continuous monitoring and final product testing.

Identify the site where design and manufacturing activities will take place, including subcontractors.

General Safety Performance Requirements GSPR

Demonstration information for general safety and performance requirements in Appendix I; includes justification, validation and verification of solutions adopted to meet the requirements.

Risk-benefit analysis and risk management

The risk benefit analysis and risk management results are included in Appendix I.

Product Validation and Verification

Should contain the results and critical analyzes of all verification and validation tests/studies performed

manufacturer

EU representative

Product Code

Production time

Validity period

Does not contain natural latex

Serial Number

Ethylene oxide sterilization

Unique device code

Do not use if the packaging is damaged

Handle with care

Phthalate free

Avoid direct sunlight

keep dry

Contains DEHP

Not reusable

Read the instructions before use

Non-sterile medical devices

Precautions

Not re-sterilizable

Storage temperature range

CE Announcement Number

Notified body code

medical instruments

Storage humidity range