In-Vitro Diagnostic Medical Device Directive
Key Facts
- Non-EU manufacturers must appoint an Authorized Representative which is established within the Union
- General IVDs may self-certify without the intervention of a Notified Body in order to affix the CE Marking
- The remaining three classes - Self-testing, Annex II list and Annex II List B - will require a QMS & Technical File to be audited by a European Notified Body
- All IVD products must undergo a pre-Market Notification before being made available, also the ones Certified by a Notified Body
- General requirements that must be met by manufacturers (Essential Requirements) are outlined in Annex I of the IVD Directive
- There is no grandfathering-in for products which have already been selling on the EU Market - manufacturers must remain up-to-date with the most recent requirements
- IVD products are not being "approved" prior sale in the EU - Competent Authorities focus on in-market controls to verify compliance
Learn More
- Scope
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
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