Conformity Assessment & Technical Documentation
Before any medical device or IVD can bear the CE marking and be placed on the EU market, it must undergo a conformity assessment to demonstrate compliance with the applicable regulation. This module covers the conformity assessment routes under both MDR (EU) 2017/745 and IVDR (EU) 2017/746, the role of Notified Bodies, CE marking, and what goes into Technical Documentation.
Select your perspective:
What Is Conformity Assessment?
Conformity assessment is the process by which a manufacturer demonstrates that a medical device or IVD meets the applicable General Safety and Performance Requirements (GSPRs) set out in MDR Annex I or IVDR Annex I. The complexity of the assessment depends on the risk class of the device.
The Core Principle
Higher risk = more scrutiny. Class I devices can largely be self-certified by the manufacturer, while Class III devices require the most extensive Notified Body involvement. This graduated approach ensures regulatory resources are focused where patient risk is greatest.
CE Marking
The visible outcome — affixed to the device after successful conformity assessment
Declaration of Conformity
Legal document signed by the manufacturer declaring compliance
Notified Body Certificate
Issued by a Notified Body for devices requiring third-party assessment
MDR Conformity Assessment Routes (MDR Article 52)
The MDR defines conformity assessment procedures in Annexes IX, X, and XI. Which route applies depends on the device classification. The manufacturer chooses the applicable procedure(s) from those available for their device class.
Class I Devices
MDR Article 52(7) — No Notified Body required (with exceptions)
For standard Class I devices, the manufacturer draws up the technical documentation, establishes the quality management system, and issues the EU Declaration of Conformity on their own. No Notified Body involvement is needed.
⚠️ Exceptions Requiring a Notified Body
- • Class I sterile (Is) — Notified Body assesses sterility aspects (Annex IX Chapter I or Annex XI Part A)
- • Class I with measuring function (Im) — Notified Body assesses metrological aspects
- • Class I reusable surgical instruments (Ir) — Notified Body assesses reprocessing aspects
Class IIa Devices
MDR Article 52(6)
Class IIa devices require Notified Body involvement. The manufacturer can choose from:
Option 1: Annex IX (QMS)
Quality management system assessment. For Class IIa, assessment of technical documentation for at least one representative device per category.
Option 2: Annex XI Part A (Production QA)
Production quality assurance combined with technical documentation assessment for at least one representative device.
Class IIb Devices
MDR Article 52(5)
More rigorous than Class IIa. The Notified Body assesses the QMS andthe technical documentation. Options include:
Option 1: Annex IX (QMS + TD)
Full quality management system assessment plus technical documentation assessment for each device.
Option 2: Annex X + XI Part B
Type examination (Annex X) combined with product conformity verification (Annex XI Part B).
Class III Devices
MDR Article 52(4)
The most rigorous assessment. Notified Body must assess both the QMS and the technical documentation for every device. Additionally, some Class III devices require expert panel consultation.
Required Route: Annex IX (Full) or Annex X + XI Part A
- • Full QMS audit including design & development
- • Technical documentation review for each device (not representative)
- • Clinical evaluation assessment including PMCF plan
- • SSCP validation by the Notified Body
- • Expert panel consultation for Class III implantable devices and Class IIb active devices delivering/removing medicines (MDR Article 54)
Why This Matters for Procurement
When evaluating medical devices for your facility, understanding the conformity assessment route tells you how much independent scrutiny the device received. A Class III device with a Notified Body certificate has undergone comprehensive third-party review, while a standard Class I device was self-certified. This doesn't mean Class I devices are unsafe — it means the regulatory system matched the assessment rigour to the risk level. Always check that certificates are current and issued by a valid EU Notified Body.
IVDR Conformity Assessment Routes (IVDR Article 48)
The IVDR follows a similar graduated approach with Annexes IX, X, and XI. Due to the reclassification, far more IVDs now require Notified Body involvement compared to the old IVDD.
| IVDR Class | Notified Body? | Routes | Additional Requirements |
|---|---|---|---|
| Class A | No (except As) | Self-assessment (Annex IX Section A) | Sterile Class A devices need NB for sterility aspects |
| Class B | Yes | Annex IX or Annex XI Part A | QMS assessment + TD for representative device |
| Class C | Yes | Annex IX or Annex X + XI | Companion diagnostics: NB must consult medicines authority |
| Class D | Yes + EU Ref Lab | Annex IX | Mandatory EU Reference Laboratory batch verification (Article 100) |
Key Regulatory References
Outlines which Annex routes apply to each device class
Full QMS audit plus technical documentation assessment by the Notified Body
NB examines a representative sample of the device type
NB audits the manufacturing QMS; used in combination with Annex X
Defines all required contents of the technical file
Requirements for PMS plan and periodic safety update reports
Requirements for the DoC content and format
Rules for affixing the CE mark to devices
IVDR-specific conformity assessment routes for IVD classes
Guidance on Notified Body designation requirements
Key Takeaways
Irish Context — Notified Bodies & Ireland
Ireland does not currently have a domestic MDR/IVDR Notified Body. Irish manufacturers typically use Notified Bodies based in other EU Member States (e.g., BSI in the Netherlands, TUV in Germany).
The HPRA is the designating authority for any future Irish Notified Body applications and oversees market surveillance of devices placed on the Irish market.
This is educational content only and is not an accredited or externally verified course. Always refer to official HPRA publications and your facility's own policies.