Conformity assessment routes of Medical
Devices in EEA under Regulation (EU)
2017/745
NAME POSITION SIGNATURE
Written by
Reviewed by
Validated by
Follow up of version
VERSION NATURE OF THE MODIFICATION APPLICATION DATE
1.0 1st version
Table of content
FOLLOW UP OF VERSION..................................................................................................................................... 1
TABLE OF CONTENT............................................................................................................................................. 2
ACRONYMS & DEFINITIONS................................................................................................................................. 3
1. SCOPE......................................................................................................................................................... 4
2. ASSOCIATED DOCUMENT............................................................................................................................ 4
3. BACKGROUND............................................................................................................................................ 4
4. OBJECTIVES................................................................................................................................................ 4
5. OVERVIEW OF THE CONFORMITY ASSESSMENT ROUTES.............................................................................5
6. CLASS I........................................................................................................................................................ 6
7. CLASS IIA.................................................................................................................................................... 7
8. CLASS IIB.................................................................................................................................................... 7
9. CLASS III...................................................................................................................................................... 8
Acronyms & Definitions
Acronyms
EEA: European Economic Area
MD: Medical Device
NB: Notified Body
QMS: Quality Management System
Definitions
Annex: annex of the Regulation (EU) 2017/745.
Category: group of medical devices defined by the Regulation (EU) 2017/745, corresponding to the MDA
or MDN codes.
Conformity assessment: generic word used for the demonstration of the conformity of both the legal
manufacturer organization and the medical device with the requirements of the Regulation (EU)
2017/745.
Conformity assessment route: procedure chosen by the legal manufacturer for the conformity
assessment of the medical device.
Generic group: group of medical devices defined by the Regulation (EU) 2017/745, corresponding to the
4th level of the European Nomenclature on Medical Devices (EMDN).
1. Scope
This Operating Manual (OPM) applies to projects which are characterized as Medical Device (MD) under
the Regulation (EU) 2017/745.
2. Associated document
SOP reference Title of the document
XXXX CE marking of conformity for Medical Devices and In Vitro Diagnosis Medical
Devices in European Economic Area (EEA)
Form reference Title of the document
N/A N/A
3. Background
To be made available on the European Economic Area (EEA), a Medical Device (MD) must be CE marked.
The CE marking of conformity is obtained after the legal manufacturer and the medical device went
through a conformity assessment process.
Applicable standard:
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on
medical devices.
4. Objectives
This Operating Manual aims to provide guidance to support the legal manufacturer in choosing the right
conformity assessment route for its device.
5. Overview of the conformity assessment routes
The conformity assessment routes are provided in the Article 52 of the Regulation, the following table
provides a visual representation of the routes which can be used regarding the class of the device.
Table 1: Overview of assessment routes for each class of device under Regulation (EU) 2017/745.
(S = sterile; M = measuring function R = reusable surgical instrument). Where there are several lines for one class,
each line represents one option of conformity assessment route.
Example:
The legal manufacturer of a class III device needs to choose between three options (three lines in the
table):
- Follow annex IX parts I, II and III,
- Follow annexes X and XI part A,
- Follow annexes X and XI part B,
o The device marketed in sterile condition, no more requirement,
o The device is marketed in sterile condition, follow annex X sections 6 and 7 in addition.
In addition to the conformity assessment routes provided in the previous table, some characteristics of
the device may require additional procedures. These procedures are listed in the following table.
Table 2: additional procedures requires for specific devices.
6. Class I
A class I device does not require the intervention of a Notified Body (NB) in its conformity assessment
route. It must comply with annexes II & III describing the requirement for the Quality Management
System (QMS) and the Technical Documentation (TD).
/!\ There is an exception for class I devices which:
Are placed on the market in sterile condition (Class Is),
Have a measuring function (Class Im),
Are a reusable surgical instrument (Class Ir).
For such device, the legal manufacturer must also choose to follow one of the following annex which will
be assessed by a NB:
Annex IX sections I & III – EU Quality Management System certificate
Annex XI Part A – EU Quality Assurance certificate
7. Class IIa
A class IIa medical device requires the intervention of a NB for the conformity assessment route.
There are three possible conformity assessment routes:
Annex IX – Full Quality System Assessment
o EU quality management system certificate
o EU technical documentation assessment certificate
Annexes II & III (TD) + annex XI Part A Section 10 (Production QA assessment)
o EU quality assurance certificate
Annexes II & III (TD) + annex XI Part B Section 18 (Product verification)
o EU product verification certificate
/!\ For devices using the annexes II & III & XI Part B Section 18 which are placed on the market in sterile
condition, the assessment of the QMS through the annex XI Part A Sections 6 to 7 is required.
The assessment of the TD is done only on 1 device per category for class IIa devices. The categories are
the MDA or MDN codes.
8. Class IIb
A class IIb medical device requires the intervention of a NB for the conformity assessment route.
There are three possible conformity assessment routes:
Annex IX – Full Quality System Assessment
o EU quality management system certificate
o EU technical documentation assessment certificate
Annex X (Type examination) + annex XI Part A (Production QA assessment)
o EU type examination certificate
o EU quality assurance certificate
Annex X (Type examination) + annex XI Part B (Product verification)
o EU type examination certificate
o EU product verification certificate
/!\ For devices using the annexes X & XI Part B which are placed on the market in sterile condition, the
assessment of the QMS through the annex XI Part A Sections 6 to 7 is required.
The assessment of the TD is done only on 1 device per generic group for class IIb devices, excepted for
implantable devices which are not sutures, staples, dental fillings, dental braces, tooth crowns, screws,
wedges, plates, wires, pins, clips and connectors. In this case, the assessment of the TD must be done on
each device. The generic group is the 4 th level of the European Nomenclature on Medical Devices
(EMDN).
9. Class III
A class III medical device requires the intervention of a NB for the conformity assessment route.
There are three possible conformity assessment routes:
Annex IX – Full Quality System Assessment
o EU quality management system certificate
o EU technical documentation assessment certificate
Annex X (Type examination) + annex XI Part A (Production QA assessment)
o EU type examination certificate
o EU quality assurance certificate
Annex X (Type examination) + annex XI Part B (Product verification)
o EU type examination certificate
o EU product verification certificate
/!\ For devices using the annexes X & XI Part B which are placed on the market in sterile condition, the
assessment of the QMS through the annex XI Part A Sections 6 to 7 is required.
The assessment of the TD of all the conformity assessment routes is done on each class III device.
