Module 15 2022

5/19/2022

Annex I GSPR – Annex II Technical Documentation

MDD

MDR

Essential Requirement

General Safety and Performance Requirement

1-6

General requirements

1-9

General requirements

7 8 9

Chemical, physical and biological properties Infection and microbial contamination Construction and environmental properties

10 11

Chemical, physical and biological properties Infection and microbial contamination

12 Devices incorporating medicinal substance or absorbed/locally dispersed

10 11

Devices with a measuring function

13 14

Devices incorporating materials of biological origin Construction of devices and interaction with their environment

Protection against radiation

12

Devices connected to or equipped with an energy source Information supplied by the manufacturer on the label and in the instructions for use

15

Devices with a measuring function

13

16

Protection against radiation

17 18 19 20 21

Electronic programmable systems

Active devices and devices connected to them Particular requirements for active implantable devices Protection against mechanical and thermal risks Protection against the risks posed to the patient or user by devices supplying energy or substances 22 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons 23 Label and instructions for use

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2017/745 Annex II – Technical Documentation

• 1. Device Description And Specification, Including Variants And Accessories • 1.1. Device description and specification (a-l) • 1.2. Reference to previous and similar generations of the device (a-b)

• 2. Information To Be Supplied By The Manufacturer

• 3. Design And Manufacturing Information (a-c)

• 4. General Safety And Performance Requirements (a-d)

• 5. Benefit-risk Analysis And Risk Management (a-b)

• 6. Product Verification And Validation • 6.1. Pre-clinical and clinical data (a-d) • 6.2. Additional information required in specific cases (a-g)

Adobe Acrobat Document

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© NAMSA 2021

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