(Under forberedelse) Europaparlaments- og rådsforordning (EU) .../... om revisjon av EU-reglene for medisinsk utstyr og in vitro-diagnostikk (forordning (EU) 2017/745 og (EU) 2017/746)
Medisinsk utstyr og in vitro-diagnostikk: revisjon (initiativ 2025)
(In preparation) Regulation (EU) .../... of the European Parliament and of the Council. Targeted revision of the EU rules for medical devices and in vitro diagnostics
Notat om planlagt forordning lagt fram av Kommisjonen 8.9.2025 med tilbakemeldingsfrist 6.10.2025
Bakgrunn
(fra Kommisjonens initiativ 8.9.2025)
Medical devices and in vitro diagnostics – targeted revision of EU rules
This initiative seeks to simplify EU rules for medical devices and in vitro diagnostics. It aims to ensure availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare.
Drawing on an evaluation of the current rules, the initiative seeks to:
- make the EU medical device sector more competitive in the internal market and globally, to support innovation and reduce dependencies;
- make safety requirements more cost-efficient and proportionate.
Call for evidence
Feedback period: 08 September 2025 - 06 October 2025