Regulatory framework - internal 2017/2185 of 23 november 2017 on the codes for the designation of notified bodies in medical devices under regulation (eu.
The european medical device regulation (eu mdr) ensures high standards of quality and safety for medical devices being produced in or supplied into europe.
As regards ar ticle 114 of the treaty on the functioning of the european union (tfeu), this regulation definition of a medical device or are covered by this.
List of european regulatory documents for medical device companies available free for download we also can help you obtain ce marking for your medical devices. The role of medical devices is essential to the healthcare of eu citizens as well as issues related to the eu’s trade and regulatory cooperation globally.
The european union’s proposed medical device regulation will soon replace the eu’s medical device directive (93/42/eec) and the directive on active implantable medical devices (90/385/eec).
Official journal of the european union the date regulation (eu) 2017/745 of the european parliament and of the council of 5 april 2017 on medical devices. New medical device regulations in europe will be finalized this year or next here’s what manufacturers can expect.
The new eu medical device regulations are expected to contribute to improved patient care and informed decision making for all stakeholders but of the many drivers for the new regulations. The european medical devices regulations - what are the requirements for vigilance reporting and post-market surveillance this paper addresses a number of areas.