Platelet-Rich Plasma in The new Medical Devices Regulation (2017/745/EU), applicable since May 2021 in EU, will replace the existing Medical Devices Directives (93/42/EEC). This regulation provides a framework for the manufacture, modification, and use of devices when equivalent devices are not commercially available (Article 5 of the Medical Device Regulation). In these situations, health care… Continue reading New Medical Device Regulation
Platelet-Rich Plasma in The new Medical Devices Regulation (2017/745/EU), applicable since May 2021 in EU, will replace the existing Medical Devices Directives (93/42/EEC).
This regulation provides a framework for the manufacture, modification, and use of devices when equivalent devices are not commercially available (Article 5 of the Medical Device Regulation). In these situations, health care facilities will be required to have appropriate quality management systems in place, to document the manufacturing process, design, and performance data of the devices, including their intended purpose, and to monitor experience gained from the clinical use of these devices.
In the case of marketed devices, the manufacturer is responsible for the quality and safety of the product.
Regen Lab actively pursues patent protection and regulatory approval of its products so that physicians have peace of mind that they can offer continuous, consistent, safe and effective treatment for their patients without the fear of being restricted in their practice.
More info about Medical Devices Regulation
More info about Regen Lab medical devices
Bruno BOEZENNEC, MD, Managing Editor