Hi friends!!!
In our previous blog, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation – Part 1
EU MDR Technical Documentation – Part 2
EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.
Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 General Safety and Performance Requirements.
Let’s discuss in detail about General Safety and Performance Requirements.
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
IN EU MDR 2017/745, Annex I talk about General Safety and Performance Requirement.
The compliance with Essential Requirements is important to establish conformity with Medical Device Directive (MDD 93/42/EEC). Likewise, the compliance with General Safety and Performance Requirements is important to establish conformity with EU MDR 2017/745.
The General Safety and Performance Requirements are classified as three Chapters as follows.
Chapter I – General Requirements
Chapter II – Requirements regarding Design and Manufacture
Chapter III – Requirements regarding the Information Supplied with the Device
Let’s discuss about the requirements of each Chapter.
Chapter I – General Requirements
This chapter focusses on Clinical safety, Device performance, Risk management, Benefit risk evaluation, Risk reduction and control. The requirements of Chapter I are as following.
1. Performance and Safety
The performance of the device shall align with the intended design of the device.
2. Reduction of Risks
Risks shall be reduced as far as possible with negatively affecting the Benefit – Risk Ratio.
3. Risk Management System
The device manufacturer shall establish a well-documented risk management system that continues to be updated throughout the life cycle of a device.
4. Risk Control measures and Residual risks
Eliminate or reduce risks as far as possible through safe design and manufacture. Take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated. Provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
5. Risks related to Use
Reduce risks related to use errors as far as possible, which includes the risks related to the ergonomic features of the device and the environment in which the device is intended to be used.
6. Device lifetime
There shall not be any compromise in the health or safety of a patient, user, or any other person associated with the device during the lifetime of the device.
7. Packaging, transport, storage
Devices must be designed, manufactured and packaged in a way that protects them from any damages during transport and storage.
8. Risk benefit ratio
All known and foreseeable risks, and any undesirable side-effects, shall be minimized and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use,
9. Devices without a medical purpose
For devices without a medical purpose, Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.
Chapter II – Requirements regarding Design and Manufacture
The Chapter II specifies requirements regarding the following.
Chemical, Physical and Biological properties.
Infection and Microbial Contamination.
Devices incorporating the substances considered to be Medicinal Product.
Devices incorporating materials of Biological Origin.
Construction of Devices & Interaction with their environment.
Devices with Diagnostic & Measuring function.
Protection against Radiation.
Electronic Programmable Systems.
Active devices & devices connected to them.
Particular requirements for active implantable devices.
Protection against Mechanical and Thermal risks.
Protection against the risks posed to the patient or user by devices supplying energy or substances.
Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons.
Chapter III – Requirements regarding the Information Supplied with the Device
The Chapter III specifies requirements regarding Label and Instruction for Use.
The Requirements are as following.
1. General requirements regarding the information supplied by the manufacturer.
2. Information on the Label.
3. Information on the packaging which maintains the sterile condition of a device (sterile packaging).
4. Information in the Instruction for Use.
Now I hope you have acquired some knowledge about EU MDR 2017/745 General Safety and Performance Requirements. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
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