Useful documents

August 2018 -

The European Commission recently updated its website and has published the below documents containing information for manufacturers.

February 2018 - 

The CAMD network publishes FAQ documents covering the transitional provisions of the MDR and IVDR.
These documents were developed by the CAMD Transition Subgroup (TSG) which was tasked with agreeing and providing greater clarity on the transition-related provisions in the new Regulations

The European Commission have also published a document entitled Withdrawal of the United Kingdom and EU rules in the field of industrial products which highlights the impact on economic operators.

August 2017 –
Presentation on EU regulations on medical devices

Linked below is an overview presentation on some of the key aspects of the new EU regulations. The HPRA were invited to present at the China International Medical Device Regulatory conference on the new EU Regulations on medical devices as a guest of the China Food and Drug Administration (CFDA) and the China Centre for Food Drug International Exchange (CCFDIE). This presentation represents the views and perspective of HPRA on the new EU Regulations on medical devices and in-vitro diagnostics and does not represent an official European view. Additional text boxes have been added to some of the slides of this presentation to cover specific points or emphasis made by the speaker. 

Niall MacAleenan's presentation at 8th China International Medical Device Regulatory Conference
New European Regulations on medical devices - Perspective of the HPRA, Ireland. 16th August 2017