MedTech is a combination of technology and medical interventions as itcovers all the equipment, tools, and devices which are employed to diagnose and treat a patient. Medical devices vary from a simple aid kit to complex scanners, radiology equipment, and laser machines, encompassing both low- and high-risk medical devices. All existing medical technologies fall under certain categories of medical devices under EU legal regulations; therefore, it is essential to understand them correctly and comply with them as patient safety is nonnegotiable priority.
Medical device manufacturers are transitioning from requirements set by European Medical Device Directives to Medical Devices Regulation (EU MDR) 2017/745. If your medical device is not sterile and is not measuring any vital functions, you are likely to fall under the procedures of self certification, if it is at the higher risk – you will working closely with a notified body.
In any case you will have to conduct a number of tests, conformity assessment, when necessary – clinical trials and provide literature review concerning your medical device for the purposes of CE marking and registration. The earlier you understand the nature and perspectives of your medical device the more focused on successful results you become. Please feel free to ask for our assistance at any stage of the development of your device.
Once your medical device is certified and registered – let’s talkmarket-wise and discuss a business model which is the most suitable for your medical device to enter the precise markets within EU.
