Pre-Market Activities
The Human Products Authorisation and Registration Department manages issues relating to the steps that medical devices manufacturers must follow before specific medical devices are placed on the market for sale. These include:
(1) Clinical Investigations
Review of applications to conduct clinical investigations which involve novel / non-CE marked medical devices.
(2) Notified Body Management
Designation and monitoring of Notified Bodies for conformity assessment in Ireland.
(3) Classification Issues
Review and advise on issues relating to the classification of medical devices e.g. borderline drug-device issues.
(4) Registration Database
Maintain a register of manufacturers of class I, custom-made, systems and procedure packs and in-vitro diagnostics medical devices.
(5) Knowledge Network
Developing knowledge within department and sourcing expert knowledge externally as required.
Medical device manufacturers must be able to demonstrate the basic safety and performance of their device prior to placing on the market. The manufacturer must therefore be able to demonstrate that their device conforms with the essential requirements and articles / schedules of the relevant Medical Device Directive e.g. 93/42/EEC.
The Irish Medicines Board also monitors Notified Body activity in Ireland. Notified Bodies assess data provided by manufacturers to establish if this data demonstrates safety and performance of the device and conformance with the essential requirements. If a Notified Body is satisfied that the device conforms then they award the device a CE mark, which allows the device to be marketed across the European Union.