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Verifarma comprehensive set of solutions serves Medical Devices manufacturers to manage labeling, reporting and quality requirements in order to ensure the compliance for upcoming EU Regulations for medical devices (MDR), in vitro diagnostic medical devices (IVDR) and improve their processes for patient safety.
New EU Regulation for Medical Devices
(adopted on April 5th 2017 and published March 5th 2017)
Main changes of the new regualtion
Inclusion of certain esthetic devices within the scope.
Minimum EU requirements related to single use reprocessing.
Stronger pre-market control of high-risk DM with MDCG.
Reinforcement of the rules on clinical evaluation and research.
Reinforced designation and supervision processes of notified bodies.
Establishment of an extensive EU database on medical devices (EUDAMED), much of the information will be made available to the public.
Introduction of a UDI system.
Verifarma MD is a smart, effective and flexible solution focused on generating the scalability organizations need for deployment while ensuring consistency, accuracy and security across data.
¿What is the UDI?
UDI = UDI DI + UDI PI
Manufacturer and product ID.
Batch, serial, informatic program, expiration date (or date of manufacture).
Basic UDI DI
- UDI-DI is the access code for information related to the device entered in EUDAMED.
- Reference to basic UDI-DI in the key documentation (declaration of conformity, certificates).
- Report serious incidents and corrective safety actions.
- Storage of the UDI for implantable MD Class III.
UDI Support = ICAD + HRI
ICAD / AIDC
Aplication MDR: UDI allocation, registered and Eudamed
Marking UDI Class III
Marking UDI Class II
Marking UDI Class I