EU MDR · Medium · 12 min lesson
IVDR scope, classification and the structure of the technical file - Regulation (EU) 2017/746, Annex VIII, Annexes II and III
Regulation (EU) 2017/746 Articles 2, 5, 10, 15, 29, 47 to 51, 79 to 81, Annex VIII, Annex II and Annex III
What you will learn
- Decide whether a product is an in vitro diagnostic device and name the manufacturer's main duties under the IVDR.
- Classify a device using the Annex VIII implementing rules and rules 1 to 7, and state the conformity route that follows.
- Lay out a technical file following Annex II and Annex III with a controlled index, and recognise a weak record.
Key takeaways
- Scope follows the intended purpose that the manufacturer states in labels, instructions and promotion (Article 2).
- The manufacturer classifies using the Annex VIII implementing rules and rules 1 to 7; the higher class applies when rules conflict.
- Calibrators and controls intended for a reagent take that reagent's class; controls without assigned values are class B (rule 7).
- The class sets the route: class A self-declared, B to D notified body, with summary of safety and performance for C and D (Article 29).
- Annex II fixes the file structure; Annex III holds the post-market plan and reports; a controlled index proves control.
Free practice question
Verano Diagnostics develops a reagent to measure a tumour marker in serum. It is sold with the claim 'supports diagnosis and staging of prostate cancer'. The engineer suggests class B because the test needs no instrument.
Which class does Annex VIII give it?
Class C, because rule 3 covers diagnosis or staging of cancer.
Correct. Annex VIII rule 3 places devices for cancer diagnosis or staging in class C, whatever instrument is used.
Class B, because it needs no instrument.
Not quite. Annex VIII does not lower a class for lack of an instrument; rule 3 covers the cancer purpose.
Class A, because serum is a common specimen.
Not quite. The specimen type does not set the class under Annex VIII; the intended purpose does, and this is cancer staging.
Class D, because every cancer test is class D.
Not quite. Annex VIII rule 1 gives class D for transmissible agents and main blood groups, not cancer markers.
Key terms
- in vitro diagnostic device: A product used in vitro on human specimens to give information on a state, condition or treatment response (Article 2(2)).
- intended purpose: The use for which a device is intended, as stated by the manufacturer in labelling, instructions and promotional material.
- Annex VIII: The annex with the implementing rules and seven classification rules that place a device in class A, B, C or D.
- technical documentation: The documents required by Annex II and Annex III that show a device meets the IVDR.
- summary of safety and performance: A public summary for class C and D devices, validated by the notified body and uploaded to Eudamed (Article 29).
- notified body: A conformity assessment body designated under the IVDR to assess devices of class A sterile, B, C and D.
Official sources
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text (EUR-Lex)
- Commission Implementing Regulation (EU) 2022/1107 on common specifications for certain class D IVDs (EUR-Lex)
- MDR Regulatory: IVDR overview of classification rules and annex structure (secondary source)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.