A sterile medical device is a product that is placed on the market in a sterile condition and labelled accordingly. Regulation (EU) 2017/745 treats this condition as the result of design, validated sterilisation, suitable packaging, and controlled manufacturing. Annex I, Chapter II, Section 11 requires that sterility is ensured when the product is placed on the market and maintained under the specified transport and storage conditions until the sterility-maintaining packaging is opened. The term “sterile” is therefore a statement about a validated process and a defined packaging system, not the result of testing the individual product.
MDR requirements for products supplied sterile
Section 11 of Annex I, Chapter II is structured in tiers. Section 11.3 requires that a specified microbial status is maintained after the product is placed on the market. For products supplied sterile, Section 11.4 additionally requires that the integrity of the sterility-maintaining packaging is clearly evident to the end user. Section 11.5 links the term “sterile” to validated procedures for processing, manufacturing, packaging, and sterilisation; Section 11.6 links it to manufacturing under controlled conditions. Section 11.8 requires that labelling makes it possible to distinguish between otherwise identical products placed on the market sterile and non-sterile.
Sterile barrier system and packaging validation
Central to this is the sterile barrier system: the minimum packaging that prevents the ingress of microorganisms and allows aseptic presentation. EN ISO 11607-1 governs the design and testing of sterile barrier and packaging systems for products sterilised in their final packaging; EN ISO 11607-2 governs validation of forming, sealing, and assembly processes. Evidence must be provided for material suitability, seal strength and integrity, resistance to transport and handling, and maintenance of the barrier function over the stated shelf life, supported by accelerated and real-time ageing. EN ISO 13485 sets out specific requirements for sterile products in Section 7.5.5 and requires validation of sterilisation processes and sterile barrier systems in Section 7.5.7.
Class Is and limited involvement of the Notified Body
Under Article 52(7), manufacturers of Class I products generally declare conformity under their own responsibility. However, if a Class I product is placed on the market sterile, the manufacturer must apply the procedures set out in Annex IX, Chapters I and III, or Annex XI, Part A. The involvement of the Notified Body is explicitly limited to aspects related to establishing, securing, and maintaining sterile conditions; this configuration is referred to as Class Is. The Notified Body therefore assesses neither the clinical evaluation nor the technical documentation otherwise, but its identification number appears alongside the CE marking.
Labelling and maintenance of the sterile condition
Annex I, Chapter III, Section 23.2(l) requires, for products supplied sterile, an indication of the sterile condition and the sterilisation method. Section 23.3 specifies the information to be provided on the sterile packaging, including its identification as sterile packaging, the declaration of the sterile condition, the sterilisation method, and the manufacturer’s name and address. The stated shelf life marks the end of the period for which barrier integrity and product performance are supported by evidence. A damaged or opened sterile barrier removes the product’s declared status regardless of the expiry date; instructions for checking the packaging and for aseptic removal therefore form part of the product information.
Distinction from products supplied non-sterile and reprocessed products
This must be distinguished from products that are supplied non-sterile and are only sterilised in the healthcare facility. In this case, the manufacturer is not responsible for the sterile condition, but for instructions and evidence of reprocessability; the information obligations are governed by EN ISO 17664-1. Also to be distinguished is the reprocessing of single-use devices under Article 17, which is only permitted with national authorisation and imposes manufacturer obligations on the reprocessor. Finally, product sterility must not be equated with the cleanliness concept of manufacturing areas: cleanrooms control bioburden; they do not demonstrate a sterile end state. The choice of process is addressed in the entries Steam sterilisation of medical devices and Ethylene oxide sterilisation of medical devices.
Relevance for clinical trials
In clinical investigations, investigational devices are often provided sterile without CE marking. The sponsor must therefore demonstrate in the documentation under Annex XV that the sterilisation processes and sterile barrier system for the investigational batches are validated, that shelf-life data cover the study duration, and that labelling and storage conditions are complied with at the investigational site. Damaged sterile packaging constitutes a product defect and must be recorded separately from adverse events, as it triggers different assessment and reporting pathways.
Operationally, this requires close integration of study logistics and quality management: batch assignment, monitoring of storage conditions, control of expiry dates, and traceability from the sterilisation lot to the study participant. If packaging, processes, or suppliers are changed during the study, the impact on sterility and shelf life must be assessed in advance. Full-service CROs such as Mediconomics support sponsors and manufacturers with the logistics of sterile investigational products, the recording of product defects, the preparation of sterilisation and packaging evidence for the technical documentation, and medical writing for the clinical investigation plan and clinical investigation report.
Frequently Asked Questions (FAQ)
Does a Class I product in a sterile condition require a Notified Body?
Yes, with a limited scope. Under Article 52(7), involvement is limited to aspects related to establishing, securing, and maintaining sterile conditions. The remaining declaration of conformity remains the manufacturer’s responsibility.
Does a product lose its sterile status if the outer packaging is damaged?
The decisive factor is the packaging that maintains the sterile condition. If this sterile barrier is damaged or opened, the product is no longer considered sterile. If the outer packaging is damaged, the barrier must be checked and documented.
How is the shelf life of a sterile product justified?
Through ageing studies of the product and packaging system in accordance with EN ISO 11607-1, supplemented by transport simulation and integrity testing. Accelerated ageing allows a provisional determination, which must be confirmed by real-time data.
Regulatory References
- Regulation (EU) 2017/745, Annex I, Chapter II, Section 11 – microbial contamination
- Regulation (EU) 2017/745, Article 52(7) – Class I in a sterile condition
- Regulation (EU) 2017/745, Annex I, Sections 23.2 and 23.3 – labelling and sterile packaging
- Regulation (EU) 2017/745, Article 17 – single-use devices and their reprocessing
- EN ISO 11607-1 and -2, EN ISO 13485 Sections 7.5.5 and 7.5.7
