Preparing for IVDR

In this project we connect 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:

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