Medical Devices Regulation (MDR) 2017/745 - Annex I General Safety and Performance Requirements https://www.aretezoe.com/medical-devices

1. GENERAL
SAFETY&
PERFORMANCE
REQUIREMENTS
ANNEX I
PAGE 1

2. PAGE 2
Devices shall achieve the performance intended by their manufacturer and shall be designed and
manufactured in such a way that, during normal conditions of use, they are suitable for their intended
purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety
of patients, or the safety and health of users or, where applicable, other persons, provided that any
risks which may be associated with their use constitute acceptable risks when weighed against the
benefits to the patient and are compatible with a high level of protection of health and safety, taking
into account the generally acknowledged state of the art.
Annex I, Chapter 1, Article 1

3. PAGE 3
RISK MANAGEMENT SYSTEM
• Risk management plan for each device
• Identify foreseeable hazards
• Evaluate risks associated with use and
reasonably foreseeable misuse
• Eliminate or control the risks
• Evaluate impact of information from
production and post-market surveillance
• Amend control measures

4. PAGE 4
RISK CONTROL MEASURES
• Residual risks associated with each
hazard must be acceptable
• Overall residual risks associated with
each hazard must be acceptable
• Eliminate risks through design and
manufacture
• Protection measures (alarms)
• Information for users - warnings,
precautions, contraindications, training
Risk control measures adopted by
manufacturers for the design and
manufacture of the devices shall conform
to safety principles, taking account of the
generally acknowledged State of the Art.

5. PAGE 5
USE ERROR
• Reduce risks relating to ergonomic
features and environment
• Consider user technical
knowledge, experience,
education, training
• Consider use environment
• Consider medical and physical
condition of intended users

6. PAGE 6
RISK MANAGEMENT SYSTEM
• Performance of the device shall last
during the lifetime of the device if
used and maintained properly
• Appropriate design and packaging for
storage and transport
• Minimize foreseeable risks and
undesirable side-effects

7. DESIGN&
MANUFACTURE
Annex I, Chapter II
PAGE 7

8. PAGE 8
CHEMICAL, PHYSICAL &
BIOLOGICAL PROPERTIES
• Toxicity of materials and substances
• Compatibility
• Mechanical properties
• Surface properties
• Devices incorporating medicinal product
• Labeling

9. Chemical, physical, biological properties
Design and manufacture shall ensure characteristics and performance of
the device in normal use.
 Choice of materials and substances considering their toxicity and flammability
 Compatibility considering intended use and substances it will be in contact with
 Compatibility with different parts of a device
 The impact of processes on material properties
 Biophysical or modelling research
 Mechanical properties
 Surface properties
 Confirmation that the device meets any defined chemical and/or physical specifications
 Minimize the risk posed by contaminants and residues
PAGE 9

10. Substances
 Minimize risk posed by substances, particles, debris and degradation products
 Prevent unintentional ingress of substances into the device
 Reduce as far as possible risk of release of particles into human body (nanomaterials)
LIMITS: 0,1% weight (w/w) limit
Devices that are in direct contact with human body, fluids or are used to administer medicines
 Carcinogenic, mutagenic and toxic to reproduction (CMR)
 Endocrine disruptors
 Phthalates
LABELING
 Concentrations >0,1% have to be declared
 Precautions for vulnerable groups in instructions for use
PAGE 10

11. Infection and microbial
contamination
Design and manufacture shall
 Reduce the risk of infection
 Risks from unintended cuts and pricks
 Easy and safe handling
 Prevent microbial leakage
 Prevent microbial contamination
 Facilitate safe cleaning, disinfection, re-sterilization
 Remain sterile during transport and storage
 Breach of sterile packaging obvious to user
 Validated methods of sterilization
 Packaging systems shall maintain integrity and cleanliness
 Labelling shall clearly distinguish sterile and non-sterile devices
PAGE 11

12. Devices incorporating a medicinal product
 Devices that are composed of substances that are
absorbed or locally dispersed
 Devices that contain a medicinal product are subject to
conformity assessment under this Regulation
 Medicinal products shall be evaluated for absorption,
distribution, metabolism, excretion, local tolerance,
toxicity, interactions and potential for adverse reactions
(Annex I to Directive 2001/83/EC)
PAGE 12

13. Devices incorporating materials of biological origin
Devices manufactured utilizing non-viable derivatives of
tissues or cells of human and animal origin:
 Donation, procurement and testing of components of
human origin subject to Directive 2004/23/EC
 Sourcing, procurement and testing of components of
animal origin subject to Regulation (EU) No 722/2012
 Processing, preservation and handling (human and
animal) shall provide safety for patients, users and
other persons.
 viruses and other transmissible agents inactivated
 traceability system (Directive 2004/23/EC, Directive
2002/98/EC)
 Animal components subjected to veterinary controls
 Geographical origin of the animals known
PAGE 13
https://althealthworks.com/12473/brazilian-doctors-put-tilapia-on-their-
patients-skin-what-happens-next-will-shock-youyelena/

14. PAGE 14
Construction, interaction with environment
Combinations of devices, including the connection
system shall be safe and shall not impair performance
 Any restrictions on use shall be declared on the label
 Minimize risk of misconnection
 Consider foreseeable external influences:
 magnetic fields, electrical, electromagnetic
 Electrostatic discharge
 Radiation (X-rays, CT)
 Variations in pressure, humidity, temperature
 acceleration
 radio signal interferences

15. PAGE 15
Construction, interaction with environment
 Contact with materials, liquids, and substances during normal conditions of use
 Negative interaction between software and IT environment
 Accidental ingress of substances into the device
 Reciprocal interference with other devices
 Ageing of materials
 Risks of fire or explosion
 Safe and effective calibration and maintenance
 Reliable and safe interoperability and compatibility
 Ergonomically designed measurement, monitoring or display scale
 Safe disposal described in instructions for use.

16. PAGE 16
DEVICES WITH A DIAGNOSTIC
OR MEASURING FUNCTION
• Accuracy, precision and
stability
• Limits of accuracy specified
• Metric units (Directive
80/181/EEC)

17. GENERAL PROTECTION AGAINST RADIATION
 Exposure reduced as far as possible
 Reducing risks inherent to
installation
 Detailed operating instructions
 Performance testing
 Maintenance procedure
PAGE 17

18. INTENDED RADIATION
 Benefits outweigh the risks
 User is able to control the emissions
 Visual displays, audible warnings
 Risk of unintended exposure
minimized
PAGE 18

19. PAGE 19
https://hackaday.com/2015/10/26/killed-by-a-machine-the-therac-25/
• Overconfidence in Software
• Confusing Reliability with Safety
• Lack of Defensive Design
• Unrealistic Risk Assessments
• Inadequate Investigation of
Incidents Follow-up on Accident
Reports
• Inadequate Software and System
Engineering Practices
• Software Reuse
• Safe versus “Friendly” User
Interfaces
• Reliance on outdated standards
https://www.computer.org/csdl/magazine/co/201
7/11/mco2017110008/13rRUxAStVR

20. PAGE 20
IONIZING RADIATION
Directive 2013/59/Euratom
Ability to control and monitor
quantity, quality and geometry of
radiation during treatment
Balance image quality and
exposure to patient
Reliable monitoring
Control of delivered dose

21. PAGE 21
ELECTRONIC PROGRAMMABLE
SYSTEMS & SOFTWARE
• Repeatability, reliability and
performance in line with intended use
• State of the art principles of security,
verification and validation
• Mobile apps features appropriate
• Minimum requirements on hardware,
IT network and security
Engadget, 2017

22. PAGE 22
NON-IMPLANTABLE ACTIVE
DEVICES
• Devices with internal power supply shall be
equipped with warnings
• Devices with external power supply alarms
must have to signal power failure
• Alarm systems on clinical monitors
• Reduce electromagnetic interference
• Reduce risk of electric shocks
• Protect against unauthorized access

23. PAGE 23
ACTIVE IMPLANTABLE DEVICES
• Minimize risk of current leakage and overheating
• Reduce risks from other treatments –
defibrillators, high-frequency surgery
• Risks arising from lack of maintenance and
calibration
• Compatibility with substances they administer
• Reliable source of energy
• Identifiable devices and components
• Code readable w/o surgery

24. PAGE 24
MECHANICAL & THERMAL
RISKS
• Resistance to movement, instability and moving parts
• Risk arising from vibration
• Reduce noise
• Safe terminals and connectors
• Prevent errors during refitting parts
• Accessible parts shall not overheat

25. PAGE 25
DEVICES SUPPLYING ENERGY
• Amount can be accurately controlled
• Prevent accidental release of dangerous
amount of energy
• Indicators of inadequate amounts
• Controls and indicators clearly specified

26. PAGE 26
DEVICES USED BY LAYPERSONS
• Devices designed to accommodate
the abilities of lay people
• Instructions for use understandable
to lay people
• Risk of unintended cuts and pricks
• Risk of error
• Procedure for laypersons to verify
functionality

27. INFORMATION
SUPPLIEDWITH
THEDEVICE
ANNEX I, CHAPTER III
PAGE 27

28. LABEL & INSTRUCTIONS FOR USE
 Identify the device and manufacturer
 Safety and performance information
 Appropriate medium and content
 Provided on device or packaging
 Human-readable, optional RFID
 Conditions for electronic IFU
 Residual risks - limitations, contra-
indications, precautions, warnings
 Internationally recognized symbols
PAGE 28

29. Information on the label
PAGE 29
Identify the device
Manufacturer or
authorized
representative
Registered place of
business
Information on
medicinal products
and human or
animal tissues
Lot #, serial #, UDI Time limitations
Storage and
handling conditions

30. Information on the label
PAGE 30
Sterile state,
sterilization
method
Single use device
Information on
medicinal products
CMR substances
and endocrine
disruptors if above
0.1% w/w
Reprocessed single
use device
Warnings and
precautions
Medical device /
investigational
device
Serial # for active
implantable
devices

31. PAGE 31
Sterile packaging
• Indication how to recognize sterile packaging
• Declaration of sterile condition
• Method of sterilization
• Manufacturer’s name and address
• Description of device
• Month and year of manufacture
• Time limit for using/implanting the device
• Instruction to check integrity of packaging before use
• “Exclusively for clinical investigations”
• “Custom-made device”

32. PAGE 32
Instructions for use
• Intended purpose, clinical benefits
• Links to summary of safety and clinical
performance
• Performance characteristics
• Corresponding software and accessories
• Residual risks, contra-indications, side
effects
• Degree of accuracy if the device has a
measuring function
• Preparatory treatment, assembly,
calibration, disinfection
• Special facilities or training
• How to verify the device is installed
properly
• Sterilization and re-sterilization instructions
• How to combine device with other
equipment
• Warnings, precautions, side effects
• Information on safe disposal
• Medicinal substances if combination
devices
• Exposure to materials if implantable