MDR (Medical Devices Regulation)
The Medical Devices Regulation (MDR) (EU) 2017/745, published in May 2017, is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. MDR repeals the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMD) 90/385/EEC on 26 May 2021.
According to the MDR, ‘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 vitroexamination 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 as referred to in the MDR Article 1(4) and of those given above.
The MDR has a transition period of three years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Manufacturers can apply for certificates to the new Regulation once their notified body is designated.
The date by which the Regulation was to be fully implemented by replacing the previous directives was originally defined as 26 May 2020. Following the international health emergency COVID-19, the European Commission and the European Parliament decided in April 2020 to postpone the deadline by one year to 26 May 2021.
EUDAMED Medical Consultancy is always ready to help you manage The Medical Devices Regulation (MDR) implementation and transition processes related to your company and the products you manufacture / import.