28/03/2022 0 Comments
Looking to bring a new medicine to the market?
The various stages of the pharmaceutical product development cycle ensures new medicines and medical devices can become viable assets in the market place.
Russell Scientific Consultants help clients with strategic planning and strategy formation when they are looking to manage the development of their product in the most efficient way possible.
We help you overcome issues and provide a clear understanding on current legislation that is in place for medicines and medical devices.
Key Aspects Of Medical Device Regulation
Clear requirements for clinical data on medical devices
Clients will need to demonstrate the safety and performance of a medical device on an ongoing basis by gathering and evaluating clinical data.
Specific Product Requirements
High-risk medical devices require clinical data criteria and specifications to determine the performance and safety of a medical device.
Pre-market Assessment of Medical Devices
Clinical concerns or emerging safety issues with similar devices can lead to medical devices being subjected to heightened scrutiny and potential reviews by an independent panel.
Enhanced Market Surveillance
Continuous risk analysis and clinical documents as well as post-market surveillance of medical devices is a task manufacturers are obliged to carry out.
Frequently Asked Questions
How are medical devices evaluated?
Medical devices are evaluated by the medicine regulatory authority in each member state - in Ireland's case, the Health Products Regulatory Authority (HPRA). The European Medicines Agency can be consulted on medical devices that contain medicinal substances.
If I am based in the EU, can I bring a medical device to market outside of the EU once the device has been authorised?
A medicine that is authorised in the EU might not be authorised or marketed outside of the EU. To get more information on the availability of medicines in other territories, it is recommended to contact the medicine regulatory authorities in these countries or regions.