Eu Medical Device Complaints

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …

EU Medical Device Vigilance Reporting in Europe - Emergo

https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe

EU medical device adverse incident and FSCA reporting process. These are the basic steps to reporting an incident in Europe: Reference MEDDEV 2.12/1 to determine the …

Quality defects and recalls | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls

Reporting obligations. Assessment of reports of product quality defects. Rapid alerts and recalls. This content applies to human and veterinary medicines. The European …

Complaint Handling Process for Medical Device …

https://www.qualitymeddev.com/2021/03/25/complaint-handling/

How to Meet New EU MDR Requirements …

https://www.assurx.com/how-to-meet-new-eu-mdr-requirements-for-vigilance-and-reporting/

While EU MDR closes gaps in the previous MDD regulation, it also means big changes to how companies handle …

The European Union Medical Device Regulation – …

https://eumdr.com/

The EU Competent Authorities for Medical Devices (CAMD) have also published FAQs specifically on the transitional arrangements: MDD to MDR and IVDD to IVDR. The …

Vigilance Reporting Requirements …

https://www.qualitymeddev.com/2021/02/25/vigilance-reporting/

According to the new EU MDR, events directly involving a medical device are considered reportable under the following circumstances: The event caused or might cause a serious public …

Medical Device Complaint Handling Processes - SimplerQMS

https://www.simplerqms.com/medical-device-complaint-handling/

Examples of medical device complaints: Labeling error resulting in 3 cc syringes labeled as 5 cc syringes Malfunctioning electric wheelchairs Mobility …

Medical Devices: Document Control Requirements …

https://www.isotracker.com/blog/medical-devices-document-control-requirements-us-and-eu/

The current document control standards of the MDSAP list the following requirements: approve documents for adequacy prior to use review and update as necessary and re-approve documents …

EU Classification of Medical Devices with examples

https://omcmedical.com/eu-classification-of-medical-devices-with-examples/

Medical devices range from low-risk products such as thermometers to high-risk devices such as pacemakers. In the European Union, the medical devices are …