GSPR Checklist

GSPR Checklist

The GSPR stands for General Safety and Performance Requirements as listed in Annex I of EU MDR 2017/745 and EU IVDR 2017/746. These requirements are similar to the Essential Requirements under MDD 93/42/EEC.

The GSPR has 23 requirements under EU MDR and 20 requirements under EU IVDR. The manufacturers who wish to get CE mark for their device have to establish conformity with these requirements and should provide sufficient evidence to demonstrate compliance with GSPR. GSPR is a core element to navigate CE marking for a device.

You can now manage GSPR within Essenvia at the device level with the Device Spaces and attach it with the Technical Documentation. 

Create a new Version of  GSPR

To create GSPR, follow the steps below:
  1. Login to Essenvia
  2. Click on the Space for which you want to create GSPR
  3. Click "GSPR" on the top navigation
  4. Click "Create new version" if you already have an existing GSPR version or click "Get started" if you do not have any prior versions

  5. Click "Continue" on the prompt

  6. Enter Version Name, Date of Submission and choose if you want to create GSPR from blank version or choose an existing GSPR version and then click "Continue"

  7. Click on the Version name on the GSPR versions screen

  8. Enter the details in the 3 Chapters

Publishing the GSPR Checklist

Follow the steps below to publish the GSPR checklist to a PDF: 
  1. Login to Essenvia
  2. Click on the Space for which you want to publish GSPR
  3. Click "GSPR" on the top navigation
  4. Click on the Version name on the GSPR versions screen

  5. Click "Preview" in the top right

  6. The GSPR Checklist PDF will be generated 

Attach GSPR to a Technical Document

Once GSPR is ready, you can easily attach it in the Appendix of the Technical Document by following the steps below:
  1. Login to Essenvia
  2. Click on the Space and navigate to the Technical Document project within the Space
  3. Click "Appendix" on the "Sections" screen within the Project

  4. Choose the version of GSPR that you would like to attach to the Technical Document and click "Attach" 

The specified GSPR version will be published as a PDF and attached to the Appendix. 

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