This document outlines the requirements for type examination of medical devices according to the Medical Devices Regulation 2017/745. It discusses the process by which a manufacturer applies to a notified body for type examination, including submitting technical documentation and a sample of the device. It also describes the notified body's assessment process, including examining documentation, reviewing clinical evidence, and testing devices. The notified body issues an EU type examination certificate if the device fulfills the regulation's requirements. Requirements are also provided for changes to the device type and record keeping.

1. ANNEXX
CONFORMITYASSESSMENT
TYPE-EXAMINATION
MEDICAL DEVICES REGULATION 2017/745
ANNEX X
PAGE 1

2. PAGE 2
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
per device generic device
group
Annex X
Type Examination
Annex XI Part B
Production verification
Class IIb Devices Annex VIII Rule 12
All active devices intended to administer and/or remove medicinal
products, body liquids or other substances to or from the body are classified
as class IIa, unless this is done in a manner that is potentially hazardous,
taking account of the nature of the substances involved, of the part of the
body concerned and of the mode of application in which case they are
classified as class IIb.
Annex IX Sec.5 / Annex X Sec. 6
Clinical Evaluation Consultation Procedure
Annex XI Part A
Production Quality
Assurance Annex IV
Declaration of
Conformity
Annex V
CE Marking

3. PAGE 3
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
per device generic device
group
Annex X
Type Examination
Annex XI Part B
Production verification
Class IIb Implantable Well-Established Technologies
Class IIb non-implantable (non-rule 12, non-WET)
Annex XI Part A
Production Quality
Assurance
Well-established technologies (WET): sutures, staples, dental fillings, dental braces,
tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
Annex IV
Declaration of
Conformity
Annex V
CE Marking

4. PAGE 4
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
For every device
Annex X
Type Examination
Annex XI Part B
Production verification
Class IIb Implantable devices (non-WET)
Annex XI Part A
Production Quality
Assurance
Well-established technologies (WET): sutures, staples,
dental fillings, dental braces, tooth crowns, screws,
wedges, plates, wires, pins, clips and connectors
Annex IV
Declaration of
Conformity
Annex V
CE Marking

5. PAGE 5
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
For every device
Annex X
Type Examination
Annex XI Part B
Production verification
Class III non-implantable devices
Consultation
2001/83/EC
EC/726/2004
2004/23/EC
EU/722/2012
Annex XI Part A
Production Quality
Assurance
Annex IV
Declaration of
Conformity
Annex V
CE Marking

6. PAGE 6
Annex I
General safety and
performance
requirements
Annex IX
Quality Management
System
Chapters I, III
Annex IX
Chapter II
Technical documentation
For every device
Annex X
Type Examination
Annex XI Part B
Production verification
Class III Implantable devices
Consultation
2001/83/EC
EC/726/2004
2004/23/EC
EU/722/2012
Annex XI Part A
Production Quality
Assurance
Annex IX Sec.5 / Annex X Sec. 6
Clinical Evaluation Consultation Procedure
Annex IV
Declaration of
Conformity
Annex V
CE Marking

7. EU type-examination
 Manufacturer applies to NB:
 Technical documentation (Annex II, Annex III)
 Sample of the device production
 Declaration that no application was lodged
with another NB
PAGE 7
NB certifies that a device, including its technical documentation
and relevant life cycle processes and a representative sample
production, fulfils the relevant provisions of this Regulation.

8. Assessment by NB
 NB staff with proven knowledge and experience
regarding the technology concerned
 Examine and assess the technical documentation
 Review clinical evidence
 Assess suitability of using data of similar or
equivalent devices
 Document outcome in EU type examination report
 Carry out/arrange physical and laboratory tests
 Verify chosen standards were applied by the
manufacturer
PAGE 8
EU type-
examination
certificateManufacturer’s details
Conditions of validity
Identification of type
approved
(Annex XII)
Relevant parts of
documentation annexed
to the certificate

9. Changes to the type
 Manufacturer informs NB of any changes to type,
its intended purpose and conditions of use
 NB shall examine the planned changes and issues
supplement EU-type examination report
Administrative provisions
 Documentation shall be kept for 10 years
(implantable devices 15 years) after the last device
has been placed on the market
PAGE 9
EU type-
examination
certificateManufacturer’s details
Conditions of validity
Identification of type
approved
(Annex XII)
Relevant parts of
documentation annexed
to the certificate