Medical Device Technical File is a must for CE Marking. Notified Body analysis the safety, efficiency and performance of the medical device after through review of your device technical file or technical documentation. Technical File must contain supporting evidences to demonstrate European medical device regulation (MDR).
EU new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will have major requirement change the way when it was compared with earlier MDD CE Marking and Technical File requirements. REGhelps will do it for you.
REGhelps is a leading services provider many companies outsource the regulatory work. Often customers take our service for a long-term goal not for a single device, but for many devices throughout the life cycle of the device.
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No, the technical file contents are different for each risk class of medical device because the type of medical device dictates the information included therein.
The purpose of a design dossier is to facilitate a design examination by a Notified Body whose goal is to verify that your medical device conforms to its technical specifications. Applicable for Class III devices as per MDD.
No, the technical file must have a Risk Management file showing the Risk analysis done on the medical device to meet the general safety and performance of it.
Yes, clinical evaluation report is a part of the technical file.
Yes, it is mandatory for devices in contact with the body or devices goes inside the body. (EN ISO 10993-1 latest version must be followed for testing)
Yes, it is mandatory for devices active devices. (IEC 60601-1 Latest edition must be followed for testing) Active device means device functions by any means of any source of energy.
Yes, it is mandatory for all type of device. No matter the class of device. The EN ISO 14971 latest version has to be adopted.
Expiry date is fixed for each device based on shelf life especially for Non active devices. Lifetime calculation is a must for active devices.