Preparing for IVDR

In this project we connected a network of professionals within NACG to collaborate on the interpretation of the IVDR and to share the burden of securing compliance with the new regulations.

Relevant links shared here are not updated after the 10th workshop.

The In Vitro Diagnostics Regulation

https://eur-lex.europa.eu/eli/reg/2017/746/oj

Guidance documents:

https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf

https://www.medical-device-regulation.eu/mdcg-endorsed-documents/

https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_mdsw_en.pdf

https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_11_guidance_qualification_classification_software_en.pdf

 

Proposed Artificial Intelligence Regulation

https://ec.europa.eu/newsroom/dae/redirection/document/75788

In House Exemption guidance for Northern Ireland (following Brexit)

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948827/Health_institution_exemption.pdf

Miscellaneous

• https://www.phgfoundation.org/briefing/what-is-the-ivdr

• https://www.phgfoundation.org/documents/algorithms-ivdr-gdpr-workshop-report.pdf

• https://www.phgfoundation.org/documents/algorithms-as-medical-devices.pdf

• https://d2evkimvhatqav.cloudfront.net/documents/md_wp_ivdr.pdf

• https://www.nice.org.uk/about/what-we-do/our-programmes/evidence-standards-framework-for-digital-health-technologies

• https://blog.limbus-medtec.com/the-ivdr-affects-how-genetic-testing-laboratories-can-operate-all-over-europe-c39749e8ef07

Nando – Database with list of Notified Bodies

• https://ec.europa.eu/growth/tools-databases/nando/index.cfm