Our Guide to Medtech Clinical Investigations

What is the Medtech Clinical Investigation Toolkit?

If you are planning a clinical investigation in Ireland, the Medtech Toolkit provides you with the information needed to do so, in one simple, concise document.

It will help Academic and/or Commercial Organisations to understand the regulatory requirements in Ireland and Europe.

It has helpful links to the relevant regulations, guidance documents and organisations with whom you will need to connect such as National Office for Research Ethics Committees and the Health Products Regulatory Authority (HPRA) .

Whether you have a lot of experience conducting Clinical Investigations in Ireland, or are completely new to the area, the Toolkit has something for everyone, and will help you to navigate the Irish system in a more streamlined manner.

The Medtech Toolkit contains information on the following topics:

• The Irish Review System
• Clinical Investigations
• Medical Device Regulations
• Medical Device Classification
• General Data Protection Regulations (GDPR)
• Good Clinical Practices
• Quality Management Systems
• Medical Device Risk Management
• Clinical Evaluation
• Medical Device Software (MDSW)
• Cyber Security and Data Protection

If you would like to find out more and sign up to recieve our toolkit, please visit our dedicated page: https://ncto.ie/medtech-toolkit/.

We also have an extensive set of pages dedicated to Clinical Investigation Support for Medtech Companies, Academics and Entrepreneurs in Ireland, find out more here: https://ncto.ie/medtech-support/.

Health Research Board (HRB) , Enterprise Ireland , Research Ireland , Irish Medtech , Health Innovation Hub Ireland .

The Toolkit is available for free; simply complete the request form below.