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  • Shlomi Zandberg

How does the PRRC help meet the Unique Device Identification (UDI) System and Article 16?

Updated: Oct 20, 2021

The new EU regulations (MDR & IVDR) are here – hurry up to follow and adapt to the changes!

According to The European Commission Q&A document (Unique Device Identification (UDI) System) in the following informative blog, you will find valuable information regarding medical devices change of legislation to prepare yourself for the new changes.

The new EU medical device regulations (EU) 745/2017 on Medical Devices (MDR) and (EU) 746/2017 on In Vitro Diagnostic (IVDR) were adopted in April 2017. The general application dates of those regulations were scheduled to 26 May 2021 and 26 May 2022, respectively.

These two regulations introduce a Unique Device Identification (UDI) system for medical devices, which you must know and start preparing yourself for the necessary adjustments, and according to Article 16 the cases of which obligations of manufacturers apply to importers, distributors or other persons.

The UDI System

The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. That means allowing an absolute identification of a specific medical device on the global market.

The UDI system should improve purchasing and waste disposal policies and stock management by health institutions and other economic operators.

The UDI production includes:

o A UDI device identifier which is specific to the device.

o A UDI production identifies the unit of device production and, if applicable, the packaged devices.

The system applies all medical devices, except custom-made and performance study/investigational devices.

The Basic UDI-DI

The Basic UDI-DI is the primary key in the device-related information in the EUDAMED database.

Its goal is to connect devices with the same intended purpose, risk class, essential design, and manufacturing characteristics.

The manufacturer is responsible for complying with all UDI related requirements. Still, he can appoint an authorized person such as PRRC to manage everything related to the UDI.

According to article 16 of the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, any importer, distributor, PRRC, or another legal person that assumes the obligations incumbent on manufacturers assumes all the relevant responsibilities related to UDI, including UDI labeling.

The obligations that importer, distributor, PRRC assumes are as following:

1. makes available on the market a device under its name, registered trade name, or registered trademark.

2. Changes the intended purpose of a device already placed on the EU market or put into service.

3. modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

Additional information on this subject is available here.

What is the mandatory deadline for a device to comply with the UDI requirements?

The UDI assignment applies as the same as the two new regulations date:

· MDR – 26 May 2021

· IVDR – 26 May 2022

The submission of UDI in the database – EUDAMED applies from:

· MDR – 26 November 2022

· IVDR – 26 November 2023

It will be possible for manufacturers to comply with the registration if they wish as from the UDI assignment dates.

To manage all the responsibilities and Finish the process smoothly, you must dive deep into the new regulations and Be aware of simple changes in the market and In order to do so, we advise you to use professional help.

How can we help you?

Our professional team at SYNC Projects can accompany your organization safely and Effectively

towards the new regulation as well as provide you with PRRC services including outsourced PRRC and consulted for PRRC in your organization.

As PRRC, we will support and ensure a fast process in which all the relevant responsibilities related to UDI, including UDI labeling, will occur as soon as possible and on the relevant dates for each step and stage.

For more information about the new MDR&IVDR regulations, UDI and PRRC services we welcome you to contact us and get a free comprehensive consultation call.

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