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What is medtech?

MedTech, or medical technology, refers to any product, service, or solution that uses medical technology to enhance people's health through illness prevention, diagnosis, monitoring, and treatment..

As a result, MedTech devices are required to improve the patient's quality of life.

Medical technology is now so widespread and incorporated into our daily lives that it is impossible to picture existence without it. Early diagnostic methods, for example, can be used to avoid disease, and diagnosis assists doctors in identifying particular problems and providing early treatment. It is stated that knowledge is the most potent weapon in the fight against sickness.

The globe is witnessing the devastating effects of the COVID-19 epidemic. MedTech is saving thousands of lives by developing medical devices (respirators), in-vitro diagnostic devices (e.g., PCR rapid testing kits), and digital health devices that use information and communication technologies to educate the public on how to protect themselves from the coronavirus and prevent its spread.

In 2018, the MedTech Industry filed about 14,000 patents with the EPO (European Patent Office). That is about the same as the number of patents registered in Pharma (7.441) and Biotechnology (6.742) combined! The European MedTech sector is expected to be worth €115 billion, with 27.000 medical technology businesses employing over 675.000 people.In-vitro diagnostic devices are expected to be the most popular device category and the number one device area in 2024.

Without a question, the European MedTech business is an appealing and profitable market to penetrate. However, the European Union is also highly stringent in terms of regulatory criteria for entering this market, therefore it is critical to understand all of the stages necessary to gain market permission (CE-marking).

To receive the CE-mark for a MedTech product, two rules must be met: IVDR 2017/746 for in-vitro diagnostics and MDR 2017/746 for medical devices. To access the European market, your goods must have a plan and transition strategy in place to bridge the gap between the existing MDD law (or IVDR) and the new MDR (or IVDR) regulation.

Furthermore, additional standards, such as the ISO 14155 standard, which describes how to design, conduct, record, and report a clinical investigation with medical devices in human subjects, and the ISO 13485 standard, which defines how to set up and maintain a Quality Management System, must be followed. Also necessary for most product approvals are the ISO 14971:2019 risk analysis standard and the ISO 26304 software standard.

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