Medical Device Regulation

All products that are used for a medical purpose, such as diagnosis, treatment or alleviation of diseases. Ultrasound devices, endoscopes, implants and training devices for therapy and rehabilitation are characterized by tested accuracy, technical and biological safety, effectiveness and intuitive usability. The highest demands are placed on these products.

The requirements are immensely high. As part of the European Medical Device Regulation EU 2017/745 and a generally certified quality management system in accordance with EN ISO 13485, all steps in planning, development and production are systematically planned, implemented, verified and validated by a team of highly qualified and motivated experts using international standards.
These requirements also apply to manufacturers based outside the EU if they place medical devices on the market within the EU.

Compliance with the specified quality standards is checked and evaluated by independent bodies (in our case TÜV Süd) in annual audits (monitoring).

This can generally be seen on the declaration of conformity for the product. Here, the manufacturer states which legal requirements the product fulfills. In the case of medical devices, at least the European Medical Device Regulation (2017/745 - MDR). In addition, the manufacturer or your device supplier is obliged to provide this declaration of conformity for each product on request. Every facility operator should have these declarations of conformity available in their facility in order to avoid possible legal consequences in the event of inquiries from the responsible state authorities.

A CE mark must be affixed to each device to indicate its conformity. This is usually located on the type plate. For many medical devices (higher classification), a four-digit identification number of a notified body must be indicated after the CE mark (e.g. TÜV Süd - CE 0123).

There are medical devices for a wide variety of user groups. The manufacturer specifies these within the scope of the intended purpose. There are also medical devices specifically designed for lay users.

For medical devices in professional use, the legislator rightly stipulates that only therapists and users who have completed appropriate training and have been instructed in the use of the medical devices may carry out diagnostics and therapy.

Yes, the risks can be considerable. If a doctor, therapist or operator does not use medical devices for medical purposes (e.g. KGG) and a patient is harmed, this can be considered negligent in case of doubt and have legal consequences.

Training devices that are approved as medical devices have

• scientifically proven clinical effectiveness,
• complete risk management,
• tested biological, electrical and mechanical safety.

The products are also subject to constant technical and clinical monitoring during use by the user in order to minimize risks and ensure successful therapy. For a lifetime.

Medical devices are subject to regular safety and/or metrological inspections or controls defined by the manufacturer. Proof of the inspections or checks must be submitted to the state offices for social services on request.

By concluding a maintenance contract, the regular inspections can be carried out automatically and documented in full.

Please note that the connection of one of our medical devices with accessories or a training control that has not been authorized by us can lead to a loss of conformity of the product and the liability risk is completely transferred to you as the operator.

Modifications to devices at the customer's premises, for example the installation of third-party software or the attachment of a different display to a device that has already been delivered, must be authorized in writing by the manufacturer beforehand, otherwise this device will lose its tested safety! This would result in the operator being fully liable for any damage or injury and the warranty and guarantee would become void.

For over 30 years, our customers worldwide have placed their trust in our medical test/training and therapy systems and supported our vision of a healthy society. You are on the safe side with us, because as an EN ISO 13485 certified, leading medical technology company, PHYSIOMED offers tested and highest safety and quality standards: Our products meet the requirements of the European Medical Device Regulation (MDR) and bear the CE mark.

As a certified company, we define a service life for our products during which time - after they have been placed on the market - there is no risk to patients and users from the product in question. Within the product lifetime, manufacturers are also obliged, for example, to provide spare parts for any repairs, as only spare parts provided by the manufacturer in accordance with the design and risk management may be used. We carry out the prescribed market observation, which must also be guaranteed within the product life cycle.

Discontinuation must be taken into account throughout the entire product life cycle of a medical device. We aim to provide our customers with professional support for our products for as long as possible - with our traffic light system, which we implement for our own products as well as our commercial products.