Astill. New methods and technologies have been introduced in the medical world making it difficult for manufacturers to classify their medical devices and know which rules apply to specific devices. Therefore the current legal framework for medical devices is outdated. In this regard the European Commission proposed new regulations in . After negotiations between the European Commission the European Council and the European Parliament the Medical Devices Regulation Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation Regulation IV on medical devices were officially adopted on April .
These regulations will replace the directives and will apply after a transition period of three Country Email List years after the publication of the Regulation on medical devices and five years after the publication of Regulation IV on medical devices . The main objective of these regulations is to modernize the existing legal framework for medical devices based on the experience of recent years and to establish a high standard for the safety of devices and their use throughout the European Union. the European legal framework for medical devices. We will focus on the key changes that the Medical Devices Regulation hereinafter referred to as the.
Regulation will bring to the people involved. Regulation IV on medical devices will not be discussed in detail but in general the comments on the regulation should also be considered when dealing with in vitro medical devices. First we must draw attention to the choice of a regulation instead of a directive. This means that once adopted the rules of the regulation will apply directly in the Member States without having to be implemented in national legislation. Consequently the legal framework for medical devices has been unified throughout the European Union. Key subjects affected by the regulations The Regulation not only contains new obligations for manufacturers but other actors in the supply.
發表於 2023-12-27 15:31:28
