Irish Authority: Practical Application of the new Regulations

The Irish Health Products Regulatory Authority (HPRA) published Information Pack on the new EU Device Legislation (MDR/ IVDR).

The guide contains practical graphs and tables addressing

  • Wider application scope of MDR;

  • New classification system of medical devices and IVDs;

  • Bigger scrutiny for Class III implantable devices and Class D IVD;

  • Validity of ”old” CE Certificates

Overview of the obligations of economic operators (Page 9). It is particularly important for distributors, importers and authorised representatives.

You can consult other Useful documents on the new Regulations in our MDlaw library.

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