Class I Medical Device: What Self-Certification Does and Does Not Mean
Updated: Aug 15
A Class I medical device is the only category under Regulation (EU) 2017/745 where a manufacturer can, in principle, declare conformity without involving a notified body. This much is widely understood. What follows from it is widely misunderstood.
What Class I medical device self-certification means
Self-certification means the manufacturer performs the conformity assessment itself, draws up the technical documentation, issues the EU declaration of conformity and affixes the CE marking without a notified body assessing the device.
It does not mean the assessment is optional or lighter in substance. The requirements against which conformity is assessed are the same general safety and performance requirements that apply to every device. What changes is who checks.
Classification itself is determined by the rules in Annex VIII. A device is Class I because those rules place it there, not because the manufacturer considers it simple.
Three exceptions for a Class I medical device
Notified body involvement is required in three situations, and the assessment in each case is limited to the specific aspect rather than covering the whole device.
A Class I medical device placed on the market in a sterile condition requires notified body involvement, limited to the aspects relating to establishing, securing and maintaining sterile conditions. These are commonly designated Class Is.
A Class I medical device with a measuring function requires notified body involvement limited to the aspects relating to conformity with metrological requirements. These are commonly designated Class Im.
A Class I medical device that is a reusable surgical instrument requires notified body involvement limited to the aspects relating to reuse — cleaning, disinfection, sterilisation, maintenance and functional testing, and the related instructions for use. These are commonly designated Class Ir.
A device falling into none of these categories is self-certified in full.
What does not change for a Class I medical device
Technical documentation is still required, in the form set out in Annexes II and III. A quality management system is still required. Clinical evaluation is still required, proportionate to the device but not omitted.
Post-market surveillance and vigilance obligations apply unchanged. Registration in EUDAMED applies unchanged, including actor registration, Basic UDI-DI and UDI-DI records.
If you are established outside the Union, the obligation to appoint an authorised representative under Article 11 applies unchanged. There is no class threshold below which that requirement stops.
Where Class I medical device manufacturers get caught
Classification is the first and most consequential risk. A device assumed to be Class I because it appears simple may be placed in a higher class by a rule that was not considered — implantable status, duration of contact, an active function, or software qualifying under its own rule.
A misclassified device has not merely been misfiled. It has been placed on the market by the wrong conformity assessment route, and correcting that is not a paperwork exercise.
Documentation is the second risk, and it is quieter. Because no notified body reviews the file, nothing forces the file to be complete until a competent authority asks for it — which is a poor moment to discover what is missing. Self-certification removes the external deadline, not the requirement.
A practical note on representation
A Class I medical device attracts the lowest representation fees, which sometimes leads manufacturers to treat the appointment as a formality.
Under Article 11(5) the liability provision applies to Class I devices in exactly the same terms as to any other class. A representative that does not read a Class I file before signing is taking the same category of risk with less information in front of it — and a representative that treats your file as routine is telling you how it will handle a problem.
Sources
Regulation (EU) 2017/745, Article 52(7) — conformity assessment for Class I devices
Regulation (EU) 2017/745, Annexes II and III — technical documentation
Regulation (EU) 2017/745, Annex VIII — classification rules
Regulation (EU) 2017/745, Article 11 and Article 19
MDCG 2021-24 — guidance on classification of medical devices
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We are not a law firm and do not provide legal advice. Send us your device list and we will respond in writing.
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