Medical Device Design and Development
Planning for the design and development of a medical device is a requirement of regulatory systems. All manufacturers of Medical
EU Medical Device Regulatory Roadmap
Following this 12 Step Guide can help you determine the regulatory roadmap for you medical device
- Step 1 - Identify if your product is a medical device
- Step 2 - Determine your device classification
- Step 3 - Review the GSPRs
- Step 4 - Start Risk Management Process
- Step 5 - Create a Quality Management System
- Step 6 - Conduct Biological Evaluation
- Step 7 - Conduct Clinical Evaluation
- Step 8 - Prepare Technical Documentation
- Step 9 - Appoint an EU Authorised Representative
- Step 10 - Notify a Notified Body
- Step 11 - Register your Device
- Step 12 - Monitor Post-Market Performance
- Medical Device Compliance & Regulations
Step 1 - Identify if your product is a medical device
Determine if your product qualifies as a medical device under EU MDR definitions and criteria.
Step 2 - Determine your device classification
Understand your device’s classification under EU MDR based on intended use and risk class.
Step 3 - Review the GSPR's
Evaluate your device against the General Safety and Performance Requirements (GSPRs) of the EU MDR.
Step 4 - Start Risk Management Process
Initiate risk management activities to identify, evaluate, and mitigate risks associated with your medical device.
Step 5 - Create a Quality Management System
Implement a QMS in accordance with ISO 13485 and EU MDR requirements.
Step 6 - Conduct Biological Evaluation
If your medical device has user/patient contact evaluate the biocompatibility of your device to ensure it is safe for its intended use.
Step 7 - Conduct Clinical Evaluation
Prepare clinical evaluation reports demonstrating device safety and performance.
Step 8 - Prepare Technical Documentation
Compile the technical documentation required for your device’s CE marking.
Step 9 - Appoint an EU Authorised Representative
Non-EU manufacturers must appoint an Authorised Representative within the EU.
Step 10 - Notify a Notified Body
Class Im (measuring), Class Is (sterile), Class Ir (reusable surgical tools), Class IIa, Class IIb and Class III medical devices require a Notified Body. Identify and work with a Notified Body to assess your device for compliance.
Step 11 - Register your Device
Register your device on EUDAMED.
Step 12 - Monitor Post-Market Performance
Establish a system for post-market surveillance (PMS) and reporting of adverse events.
Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.
Tracey Slater, Cormed
Find out more about medical device compliance and regulations
Medical Device Clinical Evaluation
Medical device clinical evaluation is an essential part of regulatory compliance. Clinical Evaluation is a review of all the data
The Biological Evaluation of Medical Devices
In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment,
ISO 13485 Standard – Quality Management System
The ISO 13485 standard was built around the structure of ISO 9001 which is a standard for Quality Management Systems
