EU 2017/745 TECHNICAL DOCUMENTATION (TECHNICAL FILE)
Manufacturers must present technical documentation demonstrating GSPR compliance before placing a medical device on the European market.
Medical devises Regulation EU 2017/745, and In-vitro Diagnostic Device Regulation EU 2017/746 must be followed when creating technical documentation.
We assist manufacturers in ensuring that their Technical Documentation complies with regulations and is acknowledged and authorized by Notified Bodies as quickly as possible.
EUROPEAN AUTHORISED REPRESENTATIVE SERVICE
Any natural or legal person identified and appointed in the European Community by the manufacturer officially to act on their behalf is known as an Authorized Representative.
Authorities and entities within the Community may approach this individual rather than contacting the orginal equipment manufacturer abroad.
CLINICAL EVALUATION OF MEDICAL DEVICES
The Clinical Evaluation Report (CER) is an important element of the technical documentation for medical devices. Clinical Evaluation Reports explain a medical device’s safety and evaluation report based on clinical data obtained from clinical inquiry and other investigations on the device.
The goal of a CER is to demonstrate that a device is safe and effective without creating a danger or harm to patients.
MEDICAL DEVICE RISK MANAGEMENT
When humans use medical devices, risk management entails identifying, understanding, controlling, and preventing failures that can result in hazards.
MEDICAL DEVICE BIOLOGICAL EVALUATION
A biological evaluation report is a compilation of data used to establish a medical device’s compatibility with the human body. In other words, the biological evaluation report establishes a medical device’s biocompatibility, or biological safety.
CLASSIFICATION OF MEDICAL AND INVITRO DIAGNOSTIC DEVICES
The new EU MDR and IVDR uses a risk-based categorization system for medical devices. The categorization of a medical device is determined by the amount of danger it poses.
IVDR MDR CE MARKING PROCESS
The new EU 2017/745 and EU 2017/746 CE Certification processes are outlined in-depth, along with the manufacturer and consultant organization’s combined duties.