Abstract:

Medical devices contribute to the attainment of the highest standards of health for individuals, but at the same time the universe of medical devices is diverse with wide variations in potential severity of harm to the patient or user. That is why competent regulatory authority in each country should allocate its resources and imposes controls proportional to the potential for harm associated with medical devices. This will result to safety improvement and high performance of medical devices when placed on the market.As part of the European Union legislative framework, on April 2017 two new proposals on medical devices were adopted. The two new legal instruments include: – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) 178/2002 and Regulation (EC) 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; – Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. The two new regulations will enter into force after a transition period of 3 for the Regulation on medical devices (spring 2020) and 5 years (spring 2022) for the Regulation on in vitro diagnostic medical devices. They will have as a result the ensurance of consistently high level of health and safety protection for all European Union citizens as well as free and fair trade of the products throughout all Member states.