Module 18 2021

05/02/2021

Annex I – Safety and performance requirements

1.

Safe, Perform as Intended, State of the Art

10.

Chemical, Physical & Biological Properties

17.

Electronic programmable systems

2.

Risk reduction as far as possible

11.

Infection & Microbial Contamination

18.

Active devices and devices connected to them

3.

Risk Management

12.

Devices incorporating a medicinal product and devices composed of substances that are absorbed by or locally dispersed in the human body Devices incorporating materials of biological origin Construction a n d interaction with the environment

19.

Requirements for AIMD

4.

Risk Control

20.

Protection against mechanical and thermal risks Protection against the risks posed to the patient or user by supplied energy or substances Protection against the risks posed by medical devices intended for use by lay persons

5.

Risk of Use Error

6.

Lifetime

21.

7.

Packaging, Transport, Storage

13.

8.

Undesirable side-effects minimised & Risks

22.

14.

9.

Annex XVI “no risk at all” or “no more than the maximum acceptable risk”

15.

Devices with a diagnostic or measuring function

23.

Information Supplied

16.

Protection against radiation

If you believe a GSPR is not relevant always state why, rather than just N/A

The Organisation for Professionals in Regulatory Affairs

33

Documentation Learning Points

Identification of Applicability and Justification

01

Ideally in the format of a checklist GSPR Checklist

Methods used to demonstrate conformity

TOP Level Summary Reports Detail from subcontractors and suppliers Demonstrates MAH is in control of product

02

Harmonised standards / Common Specifications / Other guidance or applied state of the art solutions

Detailed Reports and Data

03

Identification / Traceability of evidence

The Organisation for Professionals in Regulatory Affairs

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