MDR & IVDR Regulation

The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) align EU legislation with technical developments, changes in medical science and progress of the legislative project.

The new regulations will establish an internationally recognized, robust, transparent, predictable and sustainable regulatory framework for medical devices which ensure a high level of protection of health for patients and users. They also take into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products

Unlike directives, regulations do not need to be transposed into national law. MDR and IVDR regulations will therefore reduce differences in interpretation across the EU market.

The regulation on medical devices will be fully implemented from 26 May 2021 after the end of the transitional period.

The corresponding date of application of In Vitro Medical Devices Regulation (EU) 2017/746 remains in May 2022

The new European regulation that has been in force since May 2021 is a challenge for us. Being fully prepared and informed, we are well able to support and meet your needs in the field of Medical Devices.

“Medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilisation of devices.