We inform that on the 5th May 2017 it has been officially published the new European Regulation “MDR” (Medical Device Regulation) 2017/745, which entered into force on the 26th May 2017, and that amends the 90/385/CEE Directive concerning Active Implantable Medical Devices, and the 93/42/CEE Directive concerning Medical Devices. The new “MDR” (Medical Device Regulation) 2017/745 is intended to improve the Medical Devices safety through strict controls, making the obligations of the manufacturers, together with the supervision role carried out by the Notified Bodies, more stringent. The desired effect is to guarantee greater benefits for the patients, while maintaining a timely access to innovative solutions in the field of healthcare. The manufacturers of Medical Devices sold in Europe, will have a transitional period of three years (till the 26th May 2020) in order to adapt to the new requirements. Certain parts of the Regulation are, however, already of interest to some manufacturers and Notified Bodies. Bio Basic Europe has established internally a Department dedicated to Medical Devices, highly prepared about the subject and constantly updated on the relevant legislation. Below are mentioned the main changes regarding “MDR” (Medical Device Regulation) 2017/745: • MEDICAL DEVICE DEFINITION EXTENDED: the definition of “Active Implantable Medical Devices” and “Medical Devices” has been extended, to include also those Medical Devices which do not have a medical intended use (for example “coloured contact lenses”, “hyaluronic acid filler”, “silicone implants” etc.). • CLINICAL TRIALS: it is requested to perform clinical trials to ensure the safety and the clinical performances of each Medical Device according to the associated risk, and to perform comparative studies among Medical Devices. There is the obligation for manufacturers to store all the documentation, also post-marketing, to allow a continuous evaluation of the potential risks concerning the safety in the long term and for a large scale. • QUALIFIED PERSON: manufacturers shall identify within their organization a “qualified person” who has the responsibility of the Medical Device compliance with the essential requirements of the new regulation. • UNIQUE IDENTIFICATION (UDI): it is introduced the UDI (Unique Device Identification), a unique identification code of the Medical Device to be included in the label, in order to improve the traceability and the recalling of those products potentially dangerous to health. • EUROPEAN DATABASE “EUDAMED”: the EUDAMED database will be extended to enhance transparency and to facilitate access to data by the public and the healthcare professionals, and to strengthen the communication among European states. • STRICT POST-MARKETING SUPERVISION: carried out by the Notified Bodies, for example asking every year the manufacturer to present a document which shall confirm the post-market, safety and performance data concerning the Medical Device. • COMMON SPECIFICATIONS: European Commission together with a group of experts will publish some “common specifications” which the manufacturers and the Notified Bodies shall take into consideration. Let us remind that Bio Basic Europe has an internal research centre specialized in safety and efficacy evaluations “CDC Dermo-Clinical Research Centre”, with a team of qualified dermatologists led by a C.R.C. (Clinical Research Coordinator). C.R.C. allows us – supported by relevant Ethical Committees – to deal with the request of clinical trials, to guarantee the safety and efficacy of Medical Devices. Thank you for your attention and please contact us to get some more information or to arrange an appointment with a dedicated consultant. Technical Director Dr. Claudio Angelinetta Medical Device Dpt Responsible Dr.ssa Silvia Busoli Badiale doc@biobasiceurope.it +39024155729 Medical Device Dpt Assistant Dr.ssa Giulia Capasso doctest2@biobasiceurope.it +39024155729 BIO BASIC EUROPE S.r.l. Managing Director Dr. Umberto Pianca