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.
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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.
1.
1. Chemical,
Physical and Biological properties.
2. Infection
and Microbial Contamination.
3. Devices
incorporating the substances considered to be Medicinal Product.
4. Devices
incorporating materials of Biological Origin.
5. Construction
of Devices & Interaction with their environment.
6. Devices
with Diagnostic & Measuring function.
7. Protection
against Radiation.
8. Electronic
Programmable Systems.
9. Active
devices & devices connected to them.
10. Particular requirements for active implantable
devices.
11. Protection against Mechanical and Thermal risks.
12. Protection against the risks posed to the patient or
user by devices supplying energy or substances.
13. 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.
NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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