New European rules on medical devices (MDR) and in vitro diagnostics (IVDR) bring about major changes in the areas of active implantable medical devices, medical devices and in vitro diagnostic medical devices. The new rules affect manufacturers, importers and distributors of medical devices, healthcare institutions, healthcare providers and (indirectly) patients. This changed legislation offers opportunities for companies, clinical institutions and research institutions. The stricter safety and quality requirements require innovative implants, materials and products. Allowing innovative companies, top clinics and topresearch to work together can ensure that innovative medical devices become and remain available to the patient and thereby increase patient safety. A production facility for personalised implants for patients is being developed in the North Netherlands region. Years of scientific medical knowledge has been present here in the field of implantable medical devices. With the introduction of the new MDR legislation, opportunities can be harnessed to bring together existing knowledge and initiatives to subsequently generate a range of innovations in the field of personalised implants. An implant is an object that is placed in a human body. These include breast and dental implants, artificial lenses, hip and knee implants, heart valves, pacemakers, etc., but also material to fix broken bones and joints. The use of implants is not without risks. A risk that exists with each implant is the reaction of the human body to the (foreign) material. For example, allergic reactions may occur where the human body rejects the implant, or whose complications are so serious that people may die. Where the making and placement of an implant around the Second World War was done by a ‘handed’ surgeon, this is in the 21st century a series of different specialisations such as: materials science, materials, clinical research, production technologies (including 3D printing), IT and visualisation technology and, of course, highly specialised surgeons. Currently, standard implants are produced and customised manually for the patient during the operation. This affects the quality of the product and the fit of the implant in the patient. New knowledge, techniques and insights have led to implants being produced in a way that allows them to be personalised for the patient. In addition, the UMCG is the first party in the world to produce a personalised implant as well as fast-track. However, the regional knowledge and expertise available from the full breadth of the value chain is needed to use all the links to create a sustainable climate to create a production facility that will continuously develop high-quality personalised implants. This group of innovative companies, entrepreneurs, doctors from trauma surgery, MKA, orthopedics, the supportive UMCG 3D Lab and RUG researchers from, among others, Zernike Institute for Advanced Materials (ZIAM) and the UMCG research group BioMedical Engineering (BME) have met and found in the ambition to create a creative environment for a regional, multidisciplinary and dynamic ecosystem called “Personalised Implants”. Parties want to give energy to these issues to: bereiken:1.Hoogkwalitatieve and personalised implants for the patient 2.Fast-track production, with the latest (IT &Amp; production) technologies and materials3.Made with materials and production systems of companies in the region4.Quality throughout the (production) chain5.Active support &Amp; involvement of clinicians 6.Integrated in training and research 7.Atract for excellent students and talent 8.Perspective on commercial multiplier effectThe ecosystem “Personalised Implants” strives for efficiency and effectiveness in the transformation of the entire production value chain and all links for (g personalised) implants. This can be achieved as an ecosystem (only) through the involvement of all parties in the implant value chain (open ecosystem), focus on 4 related domains, regional and multidisciplinary cooperation and knowledge sharing and handling of (chain broad) pre- and intra-operative operating procedures and the deployment of (new) 3D visualisations and 3D planning techniques.