The new regulation applicable to the medical devices sector entered into force today: European Parliament and Council Regulations 2017/745 (for medical devices) and 2017/746 (for in vitro diagnostic medical devices).
The strengthening of the legislation in the field of clinical investigation of medical devices, the promotion of European cooperation in the control and monitoring of their manufacture and marketing, and the promotion of transparency and traceability throughout the marketing are some of the main areas targeted by the new regulations.
As measures aimed to achieve these objectives, we highlight the following news:
(i) the establishment of the Medical Devices Coordination Group ("GCDM"), a committee of medical device experts to monitor and enforce the new regulation;
(ii) the joint action and evaluation by the Community authorities in the medical devices sector, on a Joint Assessment basis;
(iii) the creation of EU Portal, a new platform that will allow the centralization of relevant information in the area of surveillance and control of the medical device sector on a European level;
(iv) the creation of EUDAMED, a new European database which processes an extensive set of information related to the marketing of medical devices, their economic agents, the clinical studies and surveillance actions to which they have been subjected;
(v) the creation of the " Unique Device Identification" (UDI), an instrument that will be associated with each medical device and which will facilitate its traceability alongside the marketing chain;
(vi) the creation of the "Implant Card", a document that becomes mandatory to transmit to the user of the medical device and which contains all the information considered essential in relation to the product.
It is worth noting the concern of this legislative reform to ensure that medical devices with a higher degree of risk and vulnerability to the human body are subject to greater control prior to their entry into the market by the competent authorities. On the other hand, in order to increase public health and safety, the Community legislature has opted to apply to some non-medical products the rules applicable to medical devices (such as contact lenses, liposuction equipment or epilation equipment laser).
The new regulation shall apply from May 2020 (for medical devices), and only from May 2022 (for in vitro diagnostic medical devices). However, we draw attention to the fact that, for certain matters, the new rules are immediately applicable.