On 25 May 2017, two new regulations on medical devices entered into force, the Medical Devices Regulation (MDR) and the Regulation on in vitro diagnostic medical devices (IVDR). These regulations replace the existing medical device directives. There is a transitional period of three years for the MDR (until 26 May 2020) and five years for the MDR IV (until 26 May 2022).
26 May 2020 is fast approaching and many medical device manufacturers have been preparing for some time. What do you need to prepare for and what do you really need to know about the MDR?
1. More software falls under the definition of medical device
In short, medical devices are healthcare products designed to detect, prevent, treat and alleviate conditions and limitations. A medical device can be a walking frame or an artificial hip, but also software created by the manufacturer to be used medically, such as […]. With the advent of MDR, the definition of a medical device changes. From that moment on, software that can make a prediction about a disorder or give a prognosis is also included in the definition, such as an app that says something about a chance of a disease based on lifestyle.
2. Software for lifestyle and welfare purposes are not medical devices
Software that is not intended for medical purposes does not qualify as a medical device, even if it can be used in practice in healthcare. However, it is important for the software manufacturer or app vendor to properly describe the intended use so that the software or app is not sold as a medical device. If the app or software is nevertheless sold as a medical device, the manufacturer is obliged to conduct further research into how the product is used in practice.
3. Software falls into a higher risk class
The MDR has different rules for risk classification. Software that provides information intended for making decisions for diagnostic or therapeutic purposes is considered to be at least Class IIa according to the MDR. This is a higher class than currently applies to this type of software. Manufacturers of these apps will therefore have to certify their product in good time via a notified body. In addition, manufacturers will have to show sufficient clinical evidence for the safety and performance of their product.
4. Software developed in-house by the healthcare institution must also comply with the MDR.
Healthcare institutions may develop their own medical devices if no devices with the required performance are yet available on the market. Most of the obligations in the MDR are addressed to manufacturers that place medical devices on the market. If the medical device is developed by the healthcare facility for its own use, the healthcare facility does not qualify as the manufacturer placing the medical device on the market. However, these medical devices must meet the general requirements for safety and performance. Deviations from this must be substantiated. In addition, the health care institution must adequately document the design in a technical file, have an appropriate quality system in place and conduct clinical evaluations.
The difference with a medical device originating from an external manufacturer is in the CE marking, which is not mandatory for medical devices developed in-house.
5. There will be a new database for medical devices
Currently the database for medical devices is ‘Eudamed2’. This is a central repository for market surveillance information intended for use by national competent authorities. With the advent of the MDR, a new, much larger EUDAMED database is also being introduced. This new EUDAMED will be multifunctional. It will function as a registration system, cooperation system, notification system and publicly accessible dissemination system. However, the new EUDAMED will not be ready on time. The obligation to register in EUDAMED has therefore been postponed for two years (until 26 May 2022).