IVDR Conformity

Assessment Routes
Notified Body Assessments

By Royal Charter
IVDR Conformity Assessment Routes 2

Contents
3 14
IVDR Classification Rules under the IVDR Class C Self-testing and NPT devices

4 16
Useful definitions Class C Companion Diagnostic (CDx) devices

5 18
Class A devices Class D with Common Specifications
(Excluding CDx)
6
Class A sterile devices
20
Class D with no Common Specifications
8 (Excluding CDx)

Class B
(Excluding self-testing NPT devices)
22
Class D CDx devices
10
Class B self-testing and NPT devices
24
How BSI supports your Medical Devices launch
12
Class C
25
(Excluding self-testing NPT and CDx devices) CE-Excellence

DISCLAIMER:

• The information presented in this brochure is based on our current understanding of the IVDR requirements at
the time of publishing and is subject to change
• The tables do not cover assessments under the conformity route of Annex XI (Production Quality Assurance).
BSI is not designated to Annex X (Type Examination)
• The Competent Authority may ask for verification testing by the EU Reference Laboratory for devices other
than Class D
IVDR Conformity Assessment Routes 3

Hover over each letter to see the examples

IVD Classification Rules under the IVDR

All devices need to be divided into classes, A, B, C, or D, taking into account their their intended purpose and inherent risks. The Classification map below allows you to allocate your device correctly.
Application of the Classification Rules shall be governed by intended purpose, novelty, complexity and inherent risk of the devices.

Rule 1 Rule 2 Rule 3 Rule 4 Rule 5 Rule 6 Rule 7

Infectious
disease

Cancer Specific IVD

Transmissible
testing reagents
Disease
Blood or Controls with
Implementing Blood N tissue N
Companion
diagnostics N Self-testing N
Instruments
N
None of the
no assigned
screening other Rules
Rules compatibility
Genetic
Specimen
receptacles
values
High risk
disease testing

Congenital
screening

Y Y Y Y Y Y Y

D C C C A B B
High risk Self-test:
blood Exempted
groups (see below-right)

Y Y Class B self-tests
• Pregnancy tests •D
 etection of glucose,
• Fertility tests erythrocytes, leucocytes
D B • Cholesterol tests and bacteria in urine
Note: See MDCG 2020-16 for full guidance

All near patient tests are

classified in their own right, they
Note: When classifying your device, can be D, C, or B, depending on
always consult the IVDR and in particular, intended purpose
Annex VIII.
IVDR Conformity Assessment Routes 4 IVDR Conformity Assessment Routes 5

Useful information Class A devices

Notified Body (NB) CA and EMA

The role of BSI as a Notified Body is to conduct In the case of companion diagnostics, the
a conformity assessment under the IVDR. This Competent Authority (CA) or the European
usually requires an audit of the manufacturer’s
quality management system and, depending on
Medicines Agency (EMA) will be consulted
regarding the associated medicinal product.
Class A
the particular classification of the device, a review Excluding sterile
of the relevant Technical Documentation in support EU Reference Laboratory
devices
of the safety and performance claims for the
These have been introduced under the IVDR
device. The Technical Documentation is assessed
and are laboratories designated by the European
against the General Safety and Performance
Commission to support with the assessment of
Requirements (GSPR) within the IVDR.
Class D IVD devices. An EU Reference Laboratory
is responsible for verifying the performance of
CE 2797
Class D IVD devices and the ongoing verification
Throughout this guide, our Notified Body is of manufactured devices. Annex II and III
referenced using its assigned Notified Body Technical
The Competent Authority may ask for verification
number: BSI The Netherlands (2797). Documentation
testing by the EU Reference Laboratory for
devices other than Class D.
Common Specifications
The European Commission provides Common
Specifications to the IVDR as a means of complying
with the legal obligations applicable to a device, Declaration of conformity
process or system, such as the General Safety (Annex IV)
and Performance Requirements (GSPRs), the Self-declaration
requirements for performance studies and
performance evaluation, and/or post-market
surveillance.

CE marking
(Annex V)

Note: No Notified Body involvement

IVDR Conformity Assessment Routes 6 IVDR Conformity Assessment Routes 7

Class A sterile devices Applicable audits, assessments and requirements

Class A sterile devices

Initial Surveillance
Class A Conformity
Sterile devices Assessment Y1 Y2 Y3 Y4 Y5

Class A Annex II and III

Technical
QMS Audits Yes Yes Yes Recert** Yes Yes

sterile Documentation
Microbiology Audits Yes N/A N/A Yes N/A N/A

Technical Documentation
N/A N/A N/A N/A N/A N/A
Assessment

Competent Authority or EMA

N/A N/A N/A N/A N/A N/A
consultation (Annex IX, Section 5.2)

Experts consultations (Article 48(6)) N/A N/A N/A N/A N/A N/A

Annex XI*
Annex IX* QMS Verification by EU reference
N/A N/A N/A N/A N/A N/A
Production Quality laboratory (Annex IX, section 4.9)
Chapters I, III
Assurance
Summary of Safety and Performance
N/A N/A N/A N/A N/A N/A
(Article 29)

Performance Evaluation Report updates (Annex XIII - Part A,

Not required for NB assessment
Section 1.3.2 and Article 56)

Post Market Performance Follow-up (PMPF) updates Evaluation

Not required for NB assessment
Report (Article 56 and Annex XIII, Part B)
Declaration of conformity
(Annex IV) Updated when necessary and made available to
Post Market Surveillance (PMS) Report (Article 80)
the Notified Body upon request

Periodic Safety Update Report (PSUR) (Article 81) N/A N/A N/A N/A N/A

Unannounced Audits At least once every 5 years

CE marking
(Annex V)
CE 2797

* Limited to sterility aspacts

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 8 IVDR Conformity Assessment Routes 9

Class B Applicable audits, assessments and requirements

Class B excluding self-testing and NPT devices
Excluding self-testing and NPT devices
Class B Initial Surveillance
Excluding self-testing Conformity

Class B Assessment Y1 Y2 Y3 Y4 Y5
and NPT devices
QMS Audits Yes Yes Yes Recert** Yes Yes
Excluding Class B
self-testing and Microbiology Audits Yes* N/A N/A Yes* N/A N/A
near-patient
testing Sample per
As per the Technical Documentation Sampling Plan. A
Technical Documentation Technical Documentation surveillance audit is required
device
Assessment every year whilst there are still devices left to be
Annex IX QMS category
reviewed under the certificate scope.
Chapters I, III
Competent Authority or EMA
N/A N/A N/A N/A N/A N/A
consultation (Annex IX, Section 5.2)

Experts consultations (article 48(6)) N/A N/A N/A N/A N/A N/A

Annex IX and Chapter II Verification by EU reference

N/A N/A N/A N/A N/A N/A
Technical Documentation laboratory (Annex IX, section 4.9)
Assessed per device category
(Section 4) Summary of Safety and
N/A N/A N/A N/A N/A N/A
Performance (Article 29)

Updated as per manufacturer’s Performance Evaluation

Performance Evaluation Report updates (Annex XIII - Part
Plan. Notified Body to review as per Technical
A, Section 1.3.2 and Article 56)
Documentation Sampling Plan
Declaration of conformity
(Annex IV) Updated as per manufacturer’s PMS, PMPF plans.
Post Market Performance Follow-up (PMPF) updates Notified Body to review as per Technical Documentation
Evaluation Report (Article 56 and Annex XIII, Part B) Sampling Plan. Implementation of the PMPF plan will be
verified during annual surveillance visits

Updated when necessary and provided to the CA

Post Market Surveillance (PMS) Report (Article 80)
and/or Notified Body upon request

Periodic Safety Update Report (PSUR)(Article 81) N/A N/A N/A N/A N/A

CE marking Unannounced Audits At least once every 5 years

(Annex V)
CE 2797
* If sterile
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 10 IVDR Conformity Assessment Routes 11

Class B self-testing and NPT devices Applicable audits, assessments and requirements
Class B, self-testing and NPT devices

Initial Surveillance
Class B Conformity
Self-testing and NPT devices Assessment Y1 Y2 Y3 Y4 Y5

Class B QMS Audits Yes Yes Yes Recert** Yes Yes

Self-testing and
Microbiology Audits Yes* N/A N/A Yes* N/A N/A
near-patient
testing Technical Documentation Review for every
N/A N/A N/A N/A Recert
Assessment device
Annex IX QMS
Competent Authority or EMA
Chapters I, III consultation (Annex IX, Section 5.2)
N/A N/A N/A N/A N/A N/A

Experts consultations (article 48(6)) N/A N/A N/A N/A N/A N/A

Verification by EU reference
Annex IX and Chapter II N/A N/A N/A N/A N/A N/A
laboratory (Annex IX, section 4.9)
Technical Documentation
Assessed per device category Summary of Safety and Performance
N/A N/A N/A N/A N/A N/A
(Section 4 and 5.1) (Article 29)

Performance Evaluation Report updates (Annex XIII - Part Updated as per Manufacturer’s Performance Evaluation
A, Plan; Notified Body to review at the time of substantial
Section 1.3.2 and Article 56) change reviews

Declaration of conformity Updated as per manufacturer’s PMS, PMPF plans.

Post Market Performance Follow-up (PMPF) updates
(Annex IV) Evaluation Report (Article 56 and Annex XIII, Part B)
Notified Body to review at the time of substantial
change reviews

Updated when necessary and provided to the CA

Post Market Surveillance (PMS) Report (Article 80) upon request. Notified Body to review at time of
substantial change reviews

Periodic Safety Update Report (PSUR) (Article 81) N/A N/A N/A N/A N/A

Unannounced Audits At least once every 5 years

CE marking
(Annex V)
CE 2797
* If sterile
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 12 IVDR Conformity Assessment Routes 13

Class C devices Applicable audits, assessments and requirements

Class C excluding self-testing, NPT and CDx devices
Excluding self-testing, NPT and CDx devices
Class C Initial Surveillance
Excluding self-testing, NPT Conformity
Assessment Y1 Y2 Y3 Y4 Y5
and CDx devices
Class C QMS Audits Yes Yes Yes Recert** Yes Yes

Excluding self-testing, Microbiology Audits Yes* N/A N/A Yes* N/A N/A
NPT and CDx
devices Sample per
As per the Technical Documentation Sampling Plan. A
Technical Documentation Technical Documentation surveillance audit is required
generic
Assessment every year whilst there are still devices left to be
Annex IX QMS device group
reviewed under the certificate scope
Chapters I, III
Competent Authority or EMA
N/A N/A N/A N/A N/A N/A
consultation (Annex IX, Section 5.2)

Experts consultations (article 48(6)) N/A N/A N/A N/A N/A N/A

Annex IX and Chapter II Verification by EU reference

N/A N/A N/A N/A N/A N/A
Technical Documentation laboratory (Annex IX, section 4.9)
Assessed per generic device
group (Section 4) Summary of Safety and Performance
Yes Updated as soon as possible, where necessary
(Article 29)

Performance Evaluation Report updates Updated at least annually. Notified Body to review as
(Annex XIII - Part A, Section 1.3.2 and Article 56) per Technical Documentation Sampling Plan

Declaration of conformity Updated as per manufacturer’s PMS, PMPF plans.

(Annex IV) Notified Body to review as per Technical
Post Market Performance Follow-up (PMPF) updates
Documentation Sampling Plan. Notified Body QMS
Evaluation Report (Article 56 and Annex XIII, Part B)
audits to verify implementation of the plan by
sampling complaints, vigilance information etc.

Post-market surveillance will be captured in the

Post Market Surveillance (PMS) Report (Article 80)
Periodic Safety Update Report

PSUR update required at least annually. The PSUR

Periodic Safety Update Report (PSUR) (Article 81)
should be available to the Notified Body upon request
CE marking
(Annex V) Unannounced Audits At least once every 5 years

CE 2797
* If sterile
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 14 IVDR Conformity Assessment Routes 15

Class C self-testing and NPT devices Applicable audits, assessments and requirements
Class C Self-testing and NPT devices

Initial Surveillance
Class C Conformity
Self-testing, and NPT devices Assessment Y1 Y2 Y3 Y4 Y5

Class C QMS Audits Yes Yes Yes Recert** Yes Yes

Self-testing and
Microbiology Audits Yes* N/A N/A Yes* N/A N/A
near-patient testing
Technical Documentation Review for every
N/A N/A N/A N/A Recert
Assessment device
Annex IX QMS
Chapters I, III Competent Authority or EMA
N/A N/A N/A N/A N/A N/A
consultation (Annex IX, Section 5.2)

Experts consultations (article 48(6)) N/A N/A N/A N/A N/A N/A

Verification by EU reference
N/A N/A N/A N/A N/A N/A
laboratory (Annex IX, section 4.9)
Annex IX and Chapter II
Technical Documentation Summary of Safety and Performance
Assessed for every device Yes Updated as soon as possible, where necessary
(Article 29)
(Section 4 and 5.1)

Updated at least annually. Notified Body to review

Performance Evaluation Report updates (Annex XIII - Part
at the time of PSUR reviews or substantial change
A, Section 1.3.2 and Article 56)
reviews

Declaration of conformity UPost Market Performance Follow-up (PMPF) updates

Updated as per manufacturer’s PMS, PMPF plans.
(Annex IV) Evaluation Report (Article 56 and Annex XIII, Part B)
Notified Body to review at the time of PSUR reviews or
substantial change reviews

Post-market surveillance will be captured in the

Post Market Surveillance (PMS) Report (Article 80)
Periodic Safety Update Report

PSUR update required at least annually. The PSUR

Periodic Safety Update Report (PSUR) (Article 81)
should be available to the Notified Body upon request

Unannounced Audits At least once every 5 years

CE marking
(Annex V)
CE 2797
* If sterile
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 16 IVDR Conformity Assessment Routes 17

Class C Companion Diagnostic (CDx) devices Applicable audits, assessments and requirements
Class C Companion Diagnostic (CDx) devices

Class C Initial Surveillance

Companion Diagnostic Conformity
Assessment Y1 Y2 Y3 Y4 Y5
Class C (CDx) devices

QMS Audits Yes Yes Yes Recert** Yes Yes

Companion
Diagnostic (CDx) Microbiology Audits Yes* N/A N/A Yes* N/A N/A
devices
Technical Documentation Review for every
Annex IX QMS N/A N/A N/A N/A Recert
Assessment device
Chapters I, III
Modifications to the devices may need supplementary
Competent Authority or EMA
Yes consultations (determined on a case-by-case basis
consultation (Annex IX, Section 5.2)
taking into account the nature of the changes proposed)

Annex IX and Chapter II

Experts consultations (article 48(6)) N/A N/A N/A N/A N/A N/A
Technical Documentation
Assessed for every device
Verification by EU reference
(Section 4 and 5.2) N/A N/A N/A N/A N/A N/A
laboratory (Annex IX, section 4.9)

Summary of Safety and Performance Updated as soon as possible, where

Yes
(Article 29) necessary
CA or EMA consultation
as per Annex IX
Section 5.2
Updated at least annually. Notified Body to review
Performance Evaluation Report updates (Annex XIII - Part
at the time of PSUR reviews or substantial change
A, Section 1.3.2 and Article 56)
reviews

Updated as per manufacturer’s PMS, PMPF plans.

Declaration of conformity Post Market Performance Follow-up (PMPF) updates
Notified Body to review at the time of PSUR reviews or
(Annex IV) Evaluation Report (Article 56 and Annex XIII, Part B)
substantial change reviews

Post-market surveillance will be captured in the

Post Market Surveillance (PMS) Report (Article 80)
Periodic Safety Update Report

PSUR update required at least annually. The PSUR

Periodic Safety Update Report (PSUR) (Article 81)
should be available to the Notified Body upon request

CE marking Unannounced Audits At least once every 5 years

(Annex V)
CE 2797
* If sterile
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 18 IVDR Conformity Assessment Routes 19

Class D with Common Specifications Applicable audits, assessments and requirements

Class D with Common Specifications (Excluding CDx)
(Excluding CDx)
Class D Initial Surveillance
with Common Specification Conformity
Assessment Y1 Y2 Y3 Y4 Y5
(Excluding CDx)
Class D QMS Audits Yes Yes Yes Recert* Yes Yes

With Common Microbiology Audits Yes* N/A N/A Yes* N/A N/A
Specifications
(Excluding CDx) Technical Documentation Review for every
N/A N/A N/A N/A Recert
Assessment device
Annex IX QMS
Chapters I, III Competent Authority or EMA
N/A N/A N/A N/A N/A N/A
consultation (Annex IX, Section 5.2)

Experts consultations (article 48(6)) N/A N/A N/A N/A N/A N/A
Annex IX and Chapter II
Modifications to the devices may need supplementary
excluding Section 5* Verification by EU reference
Yes verifications (determined on a case-by-case basis taking
Technical Documentation laboratory (Annex IX, section 4.9)
into account the nature of the changes proposed)
Assessed for every device
Summary of Safety and Performance
Yes Updated as soon as possible, where necessary
(Article 29)

Verification by EU
reference laboratory
Annex IX – Section 4.9** Performance Evaluation Report updates (Annex XIII - Part
Updated at least annually. Notified Body to review
at the time of PSUR reviews or substantial change
A, Section 1.3.2 and Article 56)
reviews

Updated as per manufacturer’s PMS, PMPF plans.

Post Market Performance Follow-up (PMPF) updates
Notified Body to review at the time of PSUR reviews or
Declaration of conformity Evaluation Report (Article 56 and Annex XIII, Part B)
substantial change reviews
(Annex IV)
Post-market surveillance will be captured in the
Post Market Surveillance (PMS) Report (Article 80)
Periodic Safety Update Report

PSUR update required at least annually. Submitted to the

Periodic Safety Update Report (PSUR) (Article 81)
Notified Body via EUDAMED for Notified Body review

Unannounced Audits At least once every 5 years

* F
 or self-test and NPT Section5.1 is
included
CE marking
** Required for devices for which one or (Annex V)
more EU Reference Laboratories have
been designated in accordance with
CE 2797 * If sterile
Article 100  MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 20 IVDR Conformity Assessment Routes 21

Class D with no Common Specifications Applicable audits, assessments and requirements

Class D with no Common Specifications (Excluding CDx)
(Excluding CDx)
Class D Initial Surveillance
with no Common Conformity
Assessment Y1 Y2 Y3 Y4 Y5
Class D Specifications (Excluding CDx)

Annex IX QMS QMS Audits Yes Yes Yes Recert** Yes Yes
with no Common Chapters I, III
Specifications Microbiology Audits Yes* N/A N/A Yes* N/A N/A
(Excluding CDx)
Technical Documentation Review for every
N/A N/A N/A N/A Recert
Assessment device
Annex IX and Chapter II
Competent Authority or EMA
excluding Section 5* consultation (Annex IX, Section 5.2)
N/A N/A N/A N/A N/A N/A
Technical Documentation
Assessed for every device Yes if the device is
Experts consultations (article 48(6)) N/A N/A N/A N/A N/A
the first of its type

Modifications to the devices may need

Verification by EU Verification by EU reference supplementary verifications (determined on a case-
Yes
reference laboratory laboratory (Annex IX, section 4.9) by-case basis taking into account the nature of the
changes proposed)
Annex IX – Section 4.9**
Summary of Safety and Performance
Yes Updated as soon as possible, where necessary
(Article 29)

Expert consultation***
Article 48 (6) Updated at least annually. Notified Body to review
Performance Evaluation Report updates (Annex XIII - Part
at the time of PSUR reviews or substantial change
A, Section 1.3.2 and Article 56)
reviews

Updated as per manufacturer’s PMS, PMPF plans.

Post Market Performance Follow-up (PMPF) updates
Notified Body to review at the time of PSUR reviews or
Evaluation Report (Article 56 and Annex XIII, Part B)
Declaration of conformity substantial change reviews
*  F
 or self-test and NPT Section 5.1 is
included
(Annex IV) Post-market surveillance will be captured in the
Post Market Surveillance (PMS) Report (Article 80)
Periodic Safety Update Report
**  Required for devices for which one
or more EU Reference Laboratories
PSUR update required at least annually. Submitted
have been designated in accordance
Periodic Safety Update Report (PSUR) (Article 81) to the Notified Body via EUDAMED for Notified
with Article 100
Body review
*** W
 here no common specification is
available, the NB shall provide the
performance evaluation report of
CE marking Unannounced Audits At least once every 5 years

the manufacturer to the Expert Panel (Annex V)

within five days of receipt. Required
in cases where the device is the first CE 2797 * If sterile
of its type.  MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
IVDR Conformity Assessment Routes 22 IVDR Conformity Assessment Routes 23

Class D CDx devices Applicable audits, assessments and requirements

Class D CDx devices

Initial Surveillance
Class D Conformity
CDx devices Assessment Y1 Y2 Y3 Y4 Y5
Class D Annex IX QMS
Chapters I, III QMS Audits Yes Yes Yes Recert** Yes Yes
CDx devices
Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Annex IX and Chapter II Technical Documentation Assessment

Review for every
N/A N/A N/A N/A Recert
device
including Section 5.2
Technical Documentation Modifications to the devices may need supplementary
Competent Authority or EMA
Assessed for every device Yes consultations (determined on a case-by-case basis
consultation (Annex IX, Section 5.2)
taking into account the nature of the changes proposed)

Yes, if no CS and
CA or EMA consultation
Experts consultations (article 48(6)) the deviceis the N/A N/A N/A N/A N/A
Annex IX, Section 5.2 first of its type

Modifications to the devices may need supplementary

Verification by EU reference
Yes verifications (determined on a case-by-case basis taking
Verification by EU laboratory (Annex IX, section 4.9)
into account the nature of the changes proposed)
reference laboratory
Annex IX – Section 4.9* Summary of Safety and Performance
Yes Updated as soon as possible, where necessary
(Article 29)

Expert consultation**
Updated at least annually. Notified Body will provide it
Article 48 (6)
Performance Evaluation Report updates (Annex XIII - Part to the expert panel as needed. Notified Body to review
A, Section 1.3.2 and Article 56) at the time of PSUR reviews or substantial change
reviews

Declaration of conformity Updated as per manufacturer’s PMS, PMPF plans.

Post Market Performance Follow-up (PMPF) updates
(Annex IV) Evaluation Report (Article 56 and Annex XIII, Part B
Notified Body to review at the time of PSUR reviews or
substantial change reviews

*  equired for devices for which one or

R Post-market surveillance will be captured in the
Post Market Surveillance (PMS) Report (Article 80)
more EU Reference Laboratories have Periodic Safety Update Report
been designated in accordance with
Article 100 PSUR update required at least annually. Submitted
Periodic Safety Update Report (PSUR) (Article 81) to the Notified Body via EUDAMED for Notified
** W
 here no common specification is CE marking Body review
available, the NB shall provide the
performance evaluation report of the (Annex V) Unannounced Audits At least once every 5 years
manufacturer to the Expert Panel within
five days of receipt. Required in cases CE 2797
* If sterile
where the device is the first of its type
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3.
IVDR Conformity Assessment Routes 24 IVDR Conformity Assessment Routes 25

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