Information and tools
Updated on 12/05/2023 - 09:41
- MDR 2017/745
- Medical devices are used to treat patients and support decisions making of the healthcare professionals.
- A medical device can refer to a mechanical device.
- A medical device can also mean a surgical invasive device that is supposed to have a biological effect.
- It can also be a liquid, a capsule to be swallowed, or a preparation to be placed under the skin.
- The distinction between wellness technology and medical devices may also be difficult, but the new EU regulations clarify this line. The separation is made according to the intended use specified by the manufacturer for the device.
In vitro diagnostics
- IVDR 2017/746
- The diagnostic industry is one of Finland's strengths in the health technology sector.
- IVD device is used either alone or in combination for medical purposes, a sample (e.g. blood, tissue, saliva, urine, faeces) is taken from a patient or healthy person and used for example to predict, precent or diagnose a disease.
- IVD device can be for example: reagents, reagent products, calibrators, reference materials, diagnostic kits, instruments, equipment, parts of hardware, software, systems or sampling containers.
Digital Health Solutions
- When it is talked about the digital health solutions it usually means tools and services based on ICT that are used in the prevention, diagnosis, and treatment of diseases, as well as the management of healthy lifestyle.
- Digital solutions can improve both access to care and the quality and safety of healthcare products and services, all cost-effectively.
- The solutions serve healthcare decision-makers, professionals, as well as patients and healthy people.
- Digital solutions, especially remote solutions, can get much closer to where the person is. Often digital solutions are used regardless of time and place, more on human than system terms.
- Health technology manufacturers, distributors and importers, as well as technology purchasing organisations are supported by a diverse range of professional services in the health sector.
- Examples fo these professional services:
- Product design, product development, contract manufacturing, documentation services, clinical evaluations and studies, risk management, validations, technical files, certifications, contractual matters, legislative matters, public procurement, deployment, maintenance, safe removal, integrations of equipment and systems, training