Ads
related to: mdr 745 2017 pdf formpdffiller.com has been visited by 1M+ users in the past month
Search results
Results From The WOW.Com Content Network
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Directive EU 2017/745 Repealed The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical devices within the European Union .
Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Help; Learn to edit; Community portal; Recent changes; Upload file
Medical Device Regulation ("MDR") — Regulation (EU) 2017/745 [5] — and in vitro diagnostic Medical Device Regulation — Regulation (EU) 2017/746 [6] — increase obligations of E.A.R in the field of surveillance of medical devices. [5]
The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information of a technical documentation for a medical device.
A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in. The Medical Device Regulation (EU) 2017/745 (MDR) provides in §2 the following definition of post-market surveillance:
For example, a notified body may designate that a medical device conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...