MedTech, or medical technology, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing, monitoring, and treating disease.
Because of this, MedTech products are necessary to improve the patient’s quality of life.
Nowadays, medical technology is so common and so integrated into our everyday life that it is difficult to imagine living without this technology. As an example, early diagnostic tools can be used to prevent disease, and the diagnosis helps doctors to identify specific conditions and provide treatment early. It is said that information is the most powerful tool against disease.
The world is experiencing the dramatic consequences of COVID-19 pandemic. MedTech is saving thousands of lives with medical devices (respirators), in-vitro diagnostic devices (e.g., PCR rapid testing kits), and digital health devices that use the information and communication technologies to inform the population about how to protect themselves from the coronavirus and how to avoid its propagation.
In 2018 the MedTech Industry registered closer to 14,000 patents in the EPO (European Patent Office) in 20181. That is approximately the same number of patents registered in Pharma (7.441) and Biotechnology (6.742), together! The MedTech market is estimated at €115 billion in Europe, and there are 27.000 medical technology companies in Europe with more than 675.000 employees2. The forecast is that in-vitro diagnostic devices will remain the highest selling category of devices, and be the number one device area in 20243.
There is no doubt that the European MedTech market is an attractive and profitable market to enter. But the European Union is also very demanding in terms of regulatory requirements to enter this market, and it is essential to know about all the steps required to obtain market authorization (CE-marking).
Different regulations are required to obtain the CE-mark of the MedTech product: IVDR 2017/746 for in-vitro diagnostic and MDR 2017/746 for medical devices. To enter the European market, you need to have a plan and transition strategy in place for your products to bridge the gap from the previous MDD legislation (or IVDR) to the new MDR (or IVDR) regulation.
Furthermore, additional standards are required to be followed, such as the ISO 14155 standard that describes how to design, conduct, record, and report a clinical investigation with medical devices in human subjects, and the ISO 13485 standard that defines how to set up and maintain a Quality Management System. Also, the ISO 14971:2019 risk analysis standard and the ISO 26304 standard for software, are two other standards required for most product approvals.
References
1- European Patent Office. Annual Report 2018
2- MedTech Europe calculation. Medtecheurope.org
3- Worldwide Medtech Sales by EvaluateMedTech® Device Area: Top 15 Categories & Total Market (2017 – 2024) – http://info.evaluategroup.com/WPMT2018-CS.html
Subject Matter Expert
Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn
