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This document applies to all medical devices and IVD medical devices and is intended to identify and describe essential principles of safety and performance which should be considered during the design and manufacturing process.
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices.
TFRs. Temporary flight restrictions (TFRs) have become more common in the post-9/11 heightened security environment, and often pop up on very short notice. Pilots should check notams before each flight by contacting flight service and/or using the FAA DUAT System program.
This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities.
#3 General Safety and Performance Requirements (GSPR) As of May 25, 2022, medical device manufacturers that are seeking market access throughout the EU must comply with Annex I - General Safety and Performance Requirements (GSPRs) of the new Medical Device Regulations (MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
23 lip 2019 · Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices.
tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally.
