DECEMBER 20218Immense attention must be paid as currently the regulatory clearance system for medical devices in the EU is facing dramatic changes in this sector with regards to the Medical Device Regulation (EU MDR 2017/745). The legislators at the European level still work on adaptions (e.g., latest published corrigendum of the MDR) and expert panels mandatory for reviewing technical documentation are not formed, yet.There are some concerns related to orthopedic devices; three of them will be highlighted in this article. Addressing them is of ample importance for the whole medical device industry since the orthopedic sector is one of the largest and fastest-growing disciplines due to, amongst others, demographic needs. Regulatory consequences at a glanceAffected by one fraud-situation regarding breast implants plus another design-related issue concerning a hip joint prosthesis leading to severe damages to patients in both cases, legislators re-visited the planned regulation to include more scrutiny and set up a more stringent vigilance system. Manufacturers are required to demonstrate compliance with the General Safety and Performance Requirements (GSPR) set in the MDR in Annex I. For implantable and class III devices a pre-market clinical investigation is required, and the equivalence demonstration will become more limited for those devices. Additionally, it is necessary to collect post-market data (PMS) systematically and actively to obtain more real-world data from the use of the devices. This is relevant for orthopedic and spinal devices, as some of them will be up-classified and most of them fall under the highest risk classification for medical devices in the EU. The EU MDR also puts the Notified Bodies (NB) under more stringent scrutiny to ensure better oversight and higher consistency in the assessment of the different NBs.Essential changes in the new EU MDR include:1. Stricter pre-market control of certain class IIb and class III implantable devices with the involvement of at the Expert Panel EU level.2. More stringent criteria and qualification requirements for the designation processes of NBs.3. Inclusion of certain aesthetic products, the so-called devices without medical purpose (devices falling under Annex 16) which represent the same characteristics and risk profile as "he same medical devices. Some orthopedic medical devices are used not only for a reconstructive indication but also for solely aesthetic signs, e.g., craniomaxillofacial plates for the transgender population.4. EU-wide database (EUDAMED) for medical devices´ EUDAMED) for medical device, and post-market surveillance.5. EU-wide requirement for an `implant card' to be provided to patients as part of higher traceability of medical devices.ORTHOPEDIC MEDICAL DEVICES UNDER THE SCOPE OF THE EU MDRDr. Max D. Singh, Global Director ­ Orthopedic Focus Team, TÜV SÜD Product Service GmbHByDr. Max D. SinghIn My Opinion
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