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HomeFactsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices
Medical devices change of legislation : what you need to know!
Metapodatki publikacije
The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulations, (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.
- Objavljeno:
- Korporativni avtor (-ji): Generalni direktorat za notranji trg, industrijo, podjetništvo ter mala in srednja podjetja (Evropska komisija)
- Področja: Zdravstvena politika , Zakonodaja in pravosodje
- Področje medicinski in kirurški instrumenti , nadzor trga , oznaka skladnosti CE , standard kakovosti , tržni standard , uredba (EU) , usklajevanje standardov , varnostni standard , zdravstvena zakonodaja
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| ISSN | ISBN 978-92-79-90405-9 | DOI 10.2873/850249 | Kataloška številka ET-02-18-961-EN-N |
- Released on EU publications website:
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