According to Article 10 of the MDR, a medical device technical file is a compilation of the documentation required to demonstrate Safety, efficiency and performance to the relevant regulation and the Notified Body. The technical file must be kept up to date throughout the life cycle of the device and must be made available on request of the competent authority via the manufacturer or through the European Authorized Representative

Declaration of Conformity

An EU declaration of conformity (DOC) is a mandatory document part of IVDR/MDR Technical Documentation. The latest signed version must be available with the manufacturer or your authorised representative. By signing the DOC, you take full responsibility for your device’s safety and regulatory compliance with the applicable EU law.

You must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.

Medical Device Labelling

To implement labelling in line with the European Medical Device Regulation (MDR) to ensure high standards of quality and safety for medical devices when used by the target population. The concerned personnel should provide the printed label and IFU for fixing on and accompanying the products to be packed for sales in those specific regions.

Medical Device Symbols

The symbols proposed in this document are validated under ISO 15223-1. Any symbol proposed in this document applies to a range of medical devices and has global and regional applicability.

·         When the risk management shows it to be appropriate for symbols to be used to convey information essential for proper use on the medical device, its packaging or in associated documentation, the symbols given in Annex I of this SOP should be used.

·         Symbols that are registered with ISO 7000 should comply with the graphical representation in ISO 7000 especially concerning relative dimensions, including relative thickness, orientation and the absence or presence of filled or shaded areas.

·         The appropriate size for the symbol to be legible for its intended function should be determined as a part of risk management.

·         It is important that the symbols be used properly. Before symbols are used, carry out a risk assessment which indicates that the use of symbols does not cause any unacceptable risk.

·         Symbols should be used without accompanying texts. Where regulations require accompanying texts, the title of the symbol given in this document should be considered enough.

·         Information essential for proper use should be indicated on the medical device, its packaging or in the associated documentation regardless of category by using the corresponding symbols given in Annex I of this SOP.

IFU/User manual Language Requirement

The marketing department should identify the language requirement of the specific country or region in the EU to which medical devices will be marketed. The identified label and the IFU will be translated by an agency or individuals who are authorized for translation and arrange for the label and IFU to be printed in the required language. After identifying language requirements for a specific country or region, the marketing department should identify the label & IFU related to the product and should list them in the Label Language Requirement Identification Sheet. The concerned personnel should contact the Competent Authority of the specific country and identify the language requirement of each label and IFU.

Risk Management File

Risk Management is a systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, and controlling risk.  The critical activities involved are the following.

·       Risk Evaluation is a process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.

·       Risk Control is a process through which decisions are reached and protective measures are implemented for reducing risks to or maintaining risks within, specified levels.

·       Risk Assessment is the overall process comprising a risk analysis and a risk evaluation.

·       Risk Analysis systematic use of available information to identify hazards and to estimate the risk.

This RMF defines the development, implementation, and maintenance of a risk management system for medical devices. It covers the risk management activities for the entire life cycle of all the medical devices from its design stage to the post-market phase, as well as for the design changes. The following regulation is applicable.

·       ISO 14971:2019 – Medical Devices – Application of risk management to medical devices

·       ISO/TR 24971:2020 – Medical Devices: Guidance on the application of ISO 14971

Clinical Evaluation Report

A clear statement concerning compliance with Clinical Evaluation must be documented in GSPR. Acceptability of the risk-benefit profile according to current knowledge/ the state of the art in the medical fields concerned and according to available medical alternatives should be explained in the technical documentation file.

Conclusion

Team I3CGLOBAL Technical Consultants help with MDR/IVDR Technical File preparation and assist medical devices by coordinating throughout the Notified Body review process. Contact us for more information.

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