Certification, approval, and CE-marking for class I sterile medical devices in the EU
The CE-marking process for Class I medical devices is generally much simpler compared to higher-risk classes. However, the moment you introduce sterility, things take a sharp turn. Unlike general Class I devices, which can often be self-certified, Class I sterile devices come with extra layers of scrutiny. That’s where notified bodies step in — though only to check one thing: sterility.
The self-certification route — but not for everyone
Class I medical devices in their simplest form enjoy what is often seen as a regulatory "shortcut." Manufacturers can self-certify their compliance with the Medical Device Regulation (MDR) 2017/745, assuming full responsibility for ensuring safety, performance, and compliance with the essential requirements. This means no external audits, no involvement from notified bodies — just a declaration from the manufacturer stating, "Yes, we meet all the requirements."
But the moment sterility enters the equation, the game changes. Class I sterile devices lose their self-certification privilege. Since maintaining sterility is critical to patient safety, the regulation requires an external party — a notified body — to step in and evaluate that aspect.
What’s special about sterile class I devices?
A sterile medical device must remain free from viable microorganisms throughout its shelf life and intended use. This means every step, from manufacturing to packaging, must be rigorously controlled. The MDR doesn’t just take a manufacturer’s word for it; it demands independent verification of sterility processes. That’s why notified bodies get involved.
However, unlike higher-risk devices (Class IIa, IIb, and III), where notified bodies review everything from design to clinical evaluation, their role for Class I sterile devices is laser-focused on one thing: sterility assurance. They don’t assess overall device performance or intended use. Instead, they review the sterilization process, cleanroom conditions, packaging integrity, and any other factors that could compromise sterility.
The notified body's role — only sterility matters
A notified body doesn’t evaluate the entire product. Instead, they examine the sterilization process and associated controls. This means reviewing:
- The sterilization method (e.g., ethylene oxide, gamma irradiation, steam sterilization)
- Validation of sterilization cycles
- Environmental controls in the production and packaging areas (cleanroom classification, monitoring)
- Packaging integrity and its ability to maintain sterility
- Compliance with ISO 11137 (for radiation sterilization) or ISO 11135 (for ethylene oxide sterilization), among others
Once they’re satisfied with the sterility processes, they issue a Notified Body Certificate—but only for the sterility aspect. The rest of the CE marking process remains the manufacturer’s responsibility. The device will still be self-certified for performance, safety, and compliance with general MDR requirements, but sterility? That’s been double-checked.
Getting the CE mark
Once the notified body signs off on sterility, the manufacturer can finalize their Declaration of Conformity, which is essentially a legally binding statement that the device meets all applicable requirements under MDR. The CE mark is then affixed, and the product is ready for the EU market.
Unlike higher-risk devices, where CE marking comes after extensive notified body involvement, Class I sterile devices maintain a hybrid approach: partial external review for sterility, but self-certification for everything else.
Why the extra hurdle for sterile devices?
Pretty obvious. It all comes down to patient safety. If a non-sterile Class I device fails, the consequences are typically minimal — perhaps an inconvenience rather than a serious health risk. But if a sterile device is compromised, there’s a real danger of infection. That’s why the regulations insist on additional oversight.
Final thoughts
For manufacturers, the takeaway is clear: Class I devices may be the simplest category under MDR, but sterility adds an extra layer of complexity. While the regulatory burden is still lighter than for higher-risk devices, there’s no escaping notified body involvement when sterility is at stake. Understanding this balance — where self-certification ends and third-party oversight begins — is key to a smooth CE marking process.
Sterile or not, every medical device manufacturer entering the EU market must be prepared to prove compliance. But when it comes to Class I sterile devices, sterility is the one area where you don’t just state compliance — you prove it.
