Notice to regarding change of HPRA case management system for medical devices

News Category: Regulatory news

Date: 02/06/2023

We will officially change to a new case management system for medical devices on 6 June.

As a result, there will be changes to the way we communicate with you regarding your case. We want you to be aware of these changes.

Please read the information below carefully to ensure this transition does not impact your correspondence with us relating to your case.

Change of case reference number (CRN)

Previously, our market surveillance or vigilance case reference numbers were displayed as VXXXXX or MSXXXXX.

Case numbers will now be alpha numerical for example CRN00011X. We will still be able to identify any closed or ongoing cases using the old reference numbers.

Changes to email communications

New cases will be assigned a dedicated e-mail address for example Case Number@case.hpra.ie.

This will enable you to send case-specific communications directly to the allocated team.

E-mail correspondence sent to you from the HPRA that is relevant to the case will come from this dedicated e-mail address.

Please consult with your IT departments to ensure that e-mails of this nature are not blocked in your organisation.

Please note that vigilance reports should continue to be submitted through devicesafety@hpra.ie

We will aim to maintain service levels during and following the transition to the new system. We appreciate your understanding and patience during this transition phase.

Finally, please contact us immediately in the unlikely event that you find any inaccurate information arising from the transition to the new system. You can do this by email at devices@hpra.ie.

Should you have any questions on the contents of this email please send them to devices@hpra.ie




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