Medical Devices Regulation (MDR) 2017/745 - Annex XIII, Conformity assessment, Custom made devices See more https://www.aretezoe.com/medical-devices

1. ANNEXXIII
CONFORMITYASSESSMENT
CUSTOM-MADEDEVICES
MEDICAL DEVICES REGULATION 2017/745
ANNEX XIII
PAGE 1

2. PAGE 2
Annex I
General safety and
performance
requirements
Annex XIII
Documentation
Annex XI Part A
Production Quality
Assurance
Custom-made class III implantable devices
Annex IX
Quality Management
System
Chapter I
Annex IV
Declaration of
Conformity
Annex V
CE Marking

3. PAGE 3
Annex I
General safety and
performance
requirements
Statement
Annex III Section 1
Annex XIII
Documentation
Custom-made devices (excl. Class III implantable)
Annex XIV Part B
PMS, PMCF

4. PAGE 4
Manufacturing
processCompliance
RISK
MANAGEMENT
SYSTEM
Clinical
evaluation
Declaration
of Conformity
Technical
documentation
QUALITY
MANAGEMENT
SYSTEM
Keep Technical
Documentation
AUTHORIZED
REPRESENTATIVEUDI system Corrective
actions
Label in
local
language
POST-MARKET
SURVEILLANCE
Incident
reporting
system
Cooperate
with
Competent
Authorities
Compensation
for damage
Field
Safety
Corrective
Actions
When placing their devices on the market
or putting them into service
GENERAL OBLIGATIONS
OF MANUFACTURERES

5. PAGE 5
GENERAL OBLIGATIONS
OF MANUFACTURERES
 Design and manufacture in compliance with this Regulation
 System for risk management (Section 3 of Annex I)
 Clinical evaluation, Post-Market Clinical Follow-Up (PMCF) (Article 61 and Annex XIV)
 Technical documentation to allow conformity assessment shall be available for 10
years (Annexes II and III)
 Technical documentation for custom-made devices (Section 2 of Annex XIII)
 Declaration of Conformation, CE marking of conformity (Article 19 and 20)
 UDI system (Article 27, 29 and 31)
 Technical documentation available for competent authorities for 10 years (implantable
devices for 15 years)
 Authorized representative permanently available
List of General Obligations of Manufacturers(Article 10)

6. PAGE 6
GENERAL OBLIGATIONS
OF MANUFACTURERES
 Procedures to ensure conformity with this Regulation
 Quality management system
 Post-market surveillance system (Article 83).
 Label in local language (Section 23 of Annex I)
 Obligation to implement corrective actions, withdraw or recall devices in case of
non-conformity
 System for recording and reporting incidents and field safety corrective actions
(Articles 87 and 88).
 Demonstrate device conformity upon request from Competent authorities
 Disclosure of legal or natural persons designated to manufacture devices
 Right to claim compensation for damage caused by a defective device
List of General Obligations of Manufacturers(Article 10)

7. PAGE 7
Statement for a patient or user
 Name and address of the manufacturer (all sites)
 Name and address of the authorized representative
 Data allowing identification of the device
 A statement that the device is intended for exclusive use
by a particular identifiable patient or user
 Prescribing health professional, incl. health institution
 Specific characteristics of the product
 Conformity statement
 General safety and performance requirements
 Medicinal substances incorporated in the device
 Keep 10 years (implantable 15 years)
General requirements
Manufacturers shall draw up, keep up to date
and keep documentation available for
conformity assessment
Surveillance
The manufacturer shall review and document
experience gained in the post-production phase,
including Post-Market Clinical Follow-Up and
implement appropriate corrective action
Reporting obligations
• Serious incidents
• Field safety corrective actions
General Obligations of Manufacturers
CUSTOM-MADE DEVICES
List of General Obligations of Manufacturers(Article 10)

8. DEVICES FOR SPECIAL PURPOSES
Member States shall not create obstacles:
 Supply of investigational devices to
investigators
 Making available custom-made devices
compliant with Annex XIII
 Devices w/o CE marking at exhibitions, trade
shows and demonstrations
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9. 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
PAGE 9
 “Exclusively for clinical investigations”
 “Custom-made device”

10. Involvement
of Notified
Bodies
 Not required for devices Class I (non-sterile, non-reusable,
w/o measuring function)
 Not required for custom-made devices (excl. custom-made
class III implantable)
 Manufacturer may apply to a NB of its choice (one only)
 NBs inform each other about withdrawn applications in
EUDAMED
 Manufacturer has the duty to disclose withdrawals and
refusals
 NB has the right to request any information required for
conformity assessment
 NBs are subject to CHAPTER IV and ANNEX VII
 Voluntary change of NB shall specify details in an
agreement
PAGE 10

11. Statement
Manufacturer draws up a Statement:
 Name and address of the manufacturer (authorized representative)
 Identification of the device
 Statement that the device is intended for exclusive use by a particular patient or user
 Prescribing professional (and health institution)
 Specific characteristics of the product as indicated by the prescription
 Statement that the device conforms to Annex I (general safety and performance
requirements)
 Information on other components (medicinal substance, human blood or plasma)
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12. Procedure
 Manufacturer shall keep documentation on the design, manufacture and
performance of the device to allow assessment of conformity
 The Statement shall be kept for 10 years (15 years implantable devices)
 Section 8 of Annex IX shall apply.
 Manufacturer shall review experience from post-production phase (PMCF)
 Manufacturer shall report any serious incidents or field safety corrective actions
PAGE 12