Official reference source
Read the linked decisions and amendments to identify the exact cited edition, the date the citation takes effect, any restriction and any cessation date. Commission summary lists provide a convenient index; legal effects follow from the relevant acts.
Indexed standard references
44 reference strings from the source snapshots are linked to this framework. The results include historical entries.
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
General requirements for in vitro diagnostic medical devices for self-testing
Performance evaluation of in vitro diagnostic medical devices
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
Review a legal citation
- Identify the governing legislation and its application to the defined product.
- Check the full standard reference, edition and amendment set in the Official Journal act.
- Read any limitations, conditions and dates attached to that citation.
- Keep the publication record and citation record separately in the evidence file.
- Review later amending and withdrawing acts before relying on the reference.