Medical Device Registration in


Ministry of Health

Department of Health

Regulatory Authority

Health Products Regulatory Authority

Medical Device Regulation

EU MDR 2017/745

Official Language

Irish, English


Class I, IIa, IIb and III

Registration Process

  • Determine the device classification
  • Appoint Authorized Representative and Notified Body
  • Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
  • For other classes, prepare a CE Technical File
  • Obtain and register UDI in EUDAMED.
  • Technical File should be audited by Notified Body.
  • Once approved, prepare a Declaration of Conformity.
  • The device can now be marketed in Ireland

Documents Required

  • CE Certificate or UKCA certificate
  • Declaration of Conformity
  • Technical File
  • QMS Certificate
  • Risk Management Plan
  • IFUs, Label or User Manual
  • Clinical Studies Report
  • Postmarket Surveillance Plan

Post-market Requirements

  • Serious public health threats – 2 day
  • Death or serious health deterioration – 10 days
  • Other serious incidents – 15 days

Applicable QMS

ISO 13485

Registration Timeline

Class I – 4-6 weeks

Others – Based on the timeline by the Notified Body

Authorized Representative


License Validity

5 years

Special Notes

IFUs or Labels should be in Irish or English

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