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Medical Device: from a Directive (MDD) to a Regulation (MDR)
Medical Device: from a Directive (MDD) to a Regulation (MDR)

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Date

04 May 2020

Medical Device: from a Directive (MDD) to a Regulation (MDR)

A “medical device” is any instrument, appliance, equipment, software, reagent, material or other item intended for use by the manufacturer on humans for one or more medical uses specificat

The Covid-19 is impacting also the timelines for the MDR readiness. EU commission is evaluating to postpone the implementation of 1 year. This can be considered an opportunity for all the stakeholders (Manufacturer, Authorized Representative, Importer, Distributor, Suppliers, Notified Body, Competent Authorities, European Commission) to deeply evaluate the transition from the current MDD to the 745/2017/UE (MDR) and 746/2017/UE (IVDR), with all the challenges and difficulties, and consequently optimize the transition.


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Let’s go back to a definition:

a medical device is any instrument, appliance, equipment, software, reagent, material or other items, intended for use by the manufacturer on humans, alone or in combination, for one or more of medical uses specifications. There are a lot of medical devices and they are classified base on the risk class. The risk class is defined based on the potential risk for the patient (class I, IIa, IIb, III).

Medical Device Reporting

The main MDR goals are to update the MDD, increasing safety on medical devices, conformity on pre-commercialization, post market surveillance, traceability on the distribution and enhance the innovation. Considering the topic of traceability, the MDR considers using an UDI (Unique Device Identification) system. The requested UDI fields (UDI-DI and UDI-PI) depend on the medical device risk class. A UDI system is intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier (to be conveyed by using Automatic Identification and Data Capture and, if applicable, its Human Readable Interpretation) based upon standard.

Considering the MDR objective on the traceability, the regulation is creating an extended traceability on the supply chain for all the stakeholders and the Economic Operators with the aim to improve patient safety. This is completely in line with Antares Vision capabilities, that can be applied from the Medical Device Economic Operators, to fulfill the regulation requirements from the UDI management on the entire supply chain. Moreover, Antares Vision solutions can manage all aspects related to the Post Market Surveillance (Complaint, Not Conformity, CAPA Management) and Vigilance (Incident, Field safety corrective action) that are related to the tracking event along the product lifecycle.

Concerning the product quality side, Antares Vision technologies can be adopted as in line/ offline/ sample control and used for the full production workflow traceability. This will be directly connected with the DHR (Device History Record) with the aim to have an optimized product control and traceability that will lead an improved method in case of any RCI (Root Cause Investigation).

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