Class I medical devices (EU Reg. 2017/745): what does it mean?
The wording "Class I Medical Device compliant with Regulation (EU) 2017/745 (MDR)" is not a bureaucratic stamp: it certifies a rigorous path of design, control and full traceability.
The regulatory framework: what the MDR is
Fully in force since 2021, replacing the previous EU directives, Regulation (EU) 2017/745 (MDR) sets the European rules for the safety and performance of all medical devices placed on the market. It divides products into four classes based on potential patient risk: I, IIa, IIb and III.
Focus on Class I: low risk, maximum duties
Postural aids and anti-decubitus systems usually fall into Class I, which groups low-risk, non-invasive devices. However, "low risk" does not mean no controls. To declare conformity, the manufacturer must:
- Draw up and keep detailed technical documentation up to date.
- Demonstrate compliance with the general safety and performance requirements.
- Implement a post-market surveillance system to monitor product behaviour over time.
- Legally affix the CE marking.
The pillars of traceability: CE, EAN and batch
- CE marking: the manufacturer's official declaration that the aid meets all safety requirements of European law.
- EAN code: the barcode that uniquely identifies the item on the market, simplifying logistics and sales management.
- Production batch: a key string that immediately traces manufacturing date and the specific raw materials used for that batch, facilitating any inspection.
Concrete advantages for facilities and individuals
- For care homes, clinics, orthopaedic and medical supply shops: essential compliance that legally protects the facility during inspections.
- For the end user: the certainty of an aid designed and manufactured to verifiable therapeutic and safety standards — not a mere comfort item.
Transparency note: this guide is for information purposes only. For any legal or regulatory matters, only the official text of Regulation (EU) 2017/745 applies.