MDR: a guarantee of safety and performance.
More safety and effectiveness with MDR certified devices.
The new European Medical Device Regulation (MDR) 2017/745, which entered into force on 26th May 2021, establishes a more stringent, articulated and up-to-date legislative regime compared to the previous Directive 93/42/EEC.
- The verification of the safety requirements of medical devices is not limited to the pre-certification phase, but must be guaranteed by the manufacturers on an ongoing basis even after the sale of the product.
- Manufacturers are therefore required to guarantee the performance of the devices, monitoring them by way of a rigorous market surveillance system.
- The traceability of the devices must be guaranteed along the entire distribution chain, from the manufacturer right through to the final consumer. In this way, the device can be promptly identified in case of any issues.
- Every medical device must be clinically updated, with the manufacturer guaranteeing its clinical efficacy over time, and updating its clinical validation with new clinical data coming from the market.
- With the entry into force of the new regulation, all new technologies are taken into consideration, including, for example, nano-materials and hazardous substances, and new stringent requirements have been introduced to guarantee the safety of the devices.
- Furthermore, many more products intended for non-medical use (e.g. contact lenses, fillers, liposuction devices, dermal treatment lasers), due to the MDR, are now included in the category of medical devices, thus imposing the same obligations of the new regulation on their manufacturers.
This is only part of the new strict requirements introduced, which require precision and rigour from manufacturing companies, and which highlight the constant need to guarantee the safety of end-users.
Thanks to the experience and incessant work of our team in technical and scientific fields, we were the first to register PEMF therapy devices, in our case the LaMagneto series, in the single European database EUDAMED according to MDR.
The certification of the LaMagneto devices has certainly not been easy. The process demanded 16 months of hard work to be able to certify the medical devices in accordance with the new provisions. However, it is a result that makes us very happy and proud, because it allows us to guarantee even safer and more reliable medical devices.