Health implications of Medical Devices Directive 93/42/EEC
This procedure is an own-initiative report examining the health impacts of the EU directive governing medical devices. It aims to evaluate whether current safety and quality standards are sufficient to protect patients and healthcare providers from risks associated with medical equipment.
The review affects medical device manufacturers, healthcare professionals, and patients. It focuses on improving product safety, labeling, and transparency to ensure that medical devices are safe and effective for public use.
Documents
[IT] Decreto legislativo del 24/02/1997 n. 46, attuazione della direttiva 93/42/CEE concernente i dispositivi medici Supplemento ordinario n .49/l alla GURI - Serie generale - del 06/03/1997 n. 54 — https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:1997-02-24;46
national transposition · IT · 2026-08-24
[NL] Besluit van 30/03/1995 medische hulpmiddelen, Staatsblad nr 243 van 1995 — https://wetten.overheid.nl/BWBR0007307
national transposition · NL · 2026-08-14
[SE] Förordning om ändring i förordningen (1993:876) om medicintekniska produkter, Svensk författningssamling SFS) 1994:1518 — https://lagen.nu/1993:876
national transposition · SV · 2026-07-29
Health implications of Medical Devices Directive 93/42/EEC
report · EN · 2026-05-23