EU MDR · Basic · 14 min lesson
Classification under MDR Annex VIII and IVDR Annex VIII rules with fictional examples
Regulation (EU) 2017/745 Article 51, Annex VIII (22 rules, classes I, IIa, IIb, III) and Annex II section 1.1; Regulation (EU) 2017/746 Article 47, Annex VIII (7 rules, classes A to D)
What you will learn
- Apply the implementing rules of MDR Annex VIII, starting from intended purpose, and use the highest applicable class.
- Classify fictional devices with the MDR rule groups for non-invasive, invasive, active and special devices, including Rule 11 for software.
- Classify fictional in vitro diagnostics under the seven IVDR Annex VIII rules and write a classification rationale an auditor can follow.
Key takeaways
- Intended purpose governs classification (Annex VIII section 3.1); fix and approve it before opening the rules.
- The MDR has 22 rules in four groups; test every rule and apply the strictest (section 3.5).
- Software follows Rule 11; accessories are classified in their own right; special rules 14 to 22 can raise the class.
- The IVDR has seven rules and classes A to D; check the listed exceptions, for example in Rule 4.
- Keep a classification report with purpose, rule scan, reviewer and revision, as Annex II section 1.1 expects.
Free practice question
Aldwych Care, a fictional maker, sells a non-sterile elastic compression sleeve for intact skin. It has no active parts, does not enter the body and has no medicinal substance.
Which MDR class results?
Class I under Rule 1, since no more specific rule applies.
Correct. MDR Annex VIII Rule 1 gives class I to non-invasive devices when no other rule applies.
Class IIb under Rule 4, because compression is a wound function.
Not quite. Rule 4 concerns devices in contact with injured skin, and the sleeve is for intact skin only. (Annex VIII)
Class III under Rule 14, because it supports circulation.
Not quite. Rule 14 covers devices with an integral medicinal substance, which this sleeve does not contain. (Annex VIII)
It cannot be classified until a notified body responds.
Not quite. Article 51 requires the manufacturer to classify first and the notified body then reviews the decision.
Key terms
- intended purpose: The use for which a device is intended according to the manufacturer data on the label, instructions, promotional material and clinical evaluation.
- classification rule: One of the 22 MDR rules or seven IVDR rules in Annex VIII used to assign a risk class.
- transient, short term, long term: Duration terms in MDR Annex VIII: under 60 minutes, 60 minutes to 30 days, and over 30 days of continuous use.
- strictest rule: Where several rules apply, the rule giving the higher class decides (MDR Annex VIII, section 3.5).
- accessory: An article intended to enable or assist a device and classified in its own right under Annex VIII section 3.2.
- class Ir: Class I reusable surgical instrument, where a notified body checks the reprocessing aspects only.
- reference laboratory: A laboratory designated to verify the performance of class D in vitro diagnostics as part of the IVDR conformity route.
Official sources
- Regulation (EU) 2017/745 (MDR), Annex VIII classification rules, EUR-Lex
- Regulation (EU) 2017/746 (IVDR), Annex VIII classification rules, EUR-Lex
- MDCG 2021-24 Guidance on classification of medical devices, European Commission
- MDCG 2020-16 Guidance on classification rules for in vitro diagnostic medical devices
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.