Compendium: EU Regulations on medical devices and IVDs
| ISBN | |
| Verkaufspreis Inland (inkl. MwSt.) | 233.00€ |
The topics covered in this compendium are:
- A Competent Authority perspective on the new European medical device and in vitro diagnostic legislation
- The challenges in implementing the new European medical device and IVD Regulations
- Economic Operators in the new European Regulations on medical devices and in vitro diagnostics
- The Medical Device Coordination Group (MDCG) – A successor to the MDEG or a new CHMP in the making?
- The impact of the new Medical Device Regulation on device/drug and drug/device combination products in Europe
- How will the new EU Medical Devices Regulation affect the reprocessing of single-use devices?
- Closing the gap between regulatory and HTA requirements for approval and reimbursement of high-risk medical devices in Europe
Specification: 60 pages plus covers, in English, supplied by email as a PDF.
These articles have been published previously in the Journal of Medical Device Regulation.
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| Verlag / Anschrift | aktualisiert am | Seitenaufrufe | |
|---|---|---|---|
| Global Regulatory Press | 25.03.2019 - 15:33 | 17 | |
| Units 317/318 Burford Business Centre, 11 Burford Road , E15 2ST London | |||
| Ansprechpartner | Marija Capek  | +44 (0)1305 264797 | |
