MEDICAL DEVICE EU REGULATION 2017/745 MDR
MEDICAL DEVICE REGULATION (EU) 2017/745
Bio Basic Europe medical device expert team lists all news and requirements about the Medical Device Regulation (EU) 2017/745.
NEWS, OBLIGATIONS AND DEADLINES
- The Technical Documentation shall be drafted according to the new Regulation (EU) 2017/745.
- Manufacturers shall identify a Person responsible for regulatory compliance (article 15) with expertise in the field of medical devices.
- European Database on Medical Devices (EUDAMED) includes 6 electronic systems. It is now active only the first form, which is optional, concerning the registration of economic operators. It will be mandatory after 6 month from the full functionality of EUDAMED, that will be later announced (provision may 2022) on the Official Journal of European Union.
- Traceability of medical devices and Unique Device Identification System (UDI system). UDI code allows the identification and traceability of the medical device on the market. Particularly:
UDI DEVICE IDENTIFIER: in force from the date of application of the two new Regulations, 26th May 2021 (medical devices) and 26th May 2022 (n vitro diagnostic medical devices).
ENTER UDI DATA IN EUDAMED: in force 24 months from the full activation of EUDAMED.
PLACING OF THE UDI on the label or on the packaging: in force according to specific deadlines, outlined below (articles 123(3)(f), 27(4)):
- 26th May 2021 - Implantable and class III devices
- 26th May 2023 - Class IIa and IIb devices
- 26th May 2025 - Class I devices
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Bio Basic Europe - Experts on medical devices