Frequently asked questions

The MDR came into effect on 26 May 2020 and the IVDR on 26 May 2022. Their purpose is to provide a high level of protection for the health of patients and users of these medical devices.

RegMetrics is a regulatory compliance software that helps companies classify their medical devices, identify safety and performance requirements, and find relevant standards and test houses.

RegMetrics can help medical device companies save time and money by streamlining the regulatory process. It can also help ensure that devices comply with all applicable regulations.

RegMetrics is a valuable tool for anyone involved in the development, manufacturing, or marketing of medical devices.

RegMetrics is developed with the input from the MedTech innovator, supporting them step by step through the regulatory compliance process. Ensuring that every MedTech innovator is empowered and understands their regulatory strategy and is able to back it up with references to credible sources.

RegMetrics takes complicated concepts and breaks it down for the users. This is in the form of ‘yes’ and ‘no’ questions, simplified forms or tick boxes.

Currently RegMetrics is able to support the innovator with the regulatory strategy for a new product. It does that by defining if the device is a medical device, what the intended purpose is and the risk classification according to the MDR or IVDR. In addition, it helps the innovators understand which clauses they need to adhere to according to the regulations. This informs which tests and verification is required, helping them plan for the next steps of their product development in accordance with the regulations.

The benefit of using RegMetrics is that it is accessible for anyone working on medical devices. You do not need to have regulatory knowledge to use RegMetrics. While you are working on your regulatory strategy, you will get a better understanding of the regulatory language. This will allow you to communicate better with a regulatory consultant saving you time and money.

A regulatory consultant and a medtech innovator did not agree on the classification for a new device. The consultant asked the innovator to classify their device using RegMetrics. When reviewing the classification summary, it was clear that the device included an active component. The innovator forgot to mention this to the consultant at their meeting, which led to the difference in classification. Using RegMetrics helped the consultant and innovator communicate more effectively, they agreed on the classification, which in turn saved a lot of time.

RegMetrics is for any medical devices or in vitro diagnostic devices, including software, aiming to bring their product or software to the European market.

Feel free to contact us at any time, we are happy to help.

RegMetrics has received the MPLS commercial impact award from the University of Oxford. More information can be found here.

By understanding the regulatory strategy from the early stages of the device development you can develop the device in accordance with the regulations, ensuring that the materials you choose are safe and the device is tested on its performance as stated in the regulations / standards. Knowing the regulatory strategy upfront fosters innovation and ultimately allows the innovation to reach the patients faster.

The RegMetrics team offers workshops in person and online for larger communities such as universities, accelerators and incubators. Feel free to get in touch and we can discuss your needs and support your community understanding the regulatory strategy.

We value your feedback on how we can improve our offering. If you have 5 minutes to complete our Continuous Improvement Questionnaire.