Class 1s Medical Device

The sterile medical devices (Class Is) are simple device with low risk manufactured and packed by the manufacturer in sterile condition. Class 1s medical devices are normally used without a connection to an active device. The user must ensure device sterility before use by checking for any damage in the packaging and discarded after use.

Below image explains the process and important documentation requirements for CE Certification for (class 1s) sterile low risk single use medical devices.

MDR class Is sterile medical device conformity assessment route for CE certification is detailed below.

For Class 1s medical device that are intended to be sterile, the MDR sets forth specific requirements:

• The medical device must be sterilised using a validated process. The method of sterilization should be appropriate for the device’s material and design. Common methods include steam, ethylene oxide, or radiation. The technical documentation should cover detailed sterilisation protocol covering IQ,OQ and PQ. The Validation report must have a conclusion about the final output of validation and all supporting data to establish validation conduct.
• Manufacturers need to maintain detailed records of the sterilisation process, including validation and routine control procedures. This documentation is part of the technical documentation required for the device and should be available for review by regulatory authorities if needed.
• The sterilisation process should comply with relevant standards, such as ISO 11135, ISO 11137, ISO 17665 and ISO 17664 , to ensure that the device is consistently sterile.
• Sterile Class 1s medical device must be packaged in a way that maintains their sterility until the point of use and throughout the shellfire period.  The packaging should be sealed and labeled to ensure that it is not compromised. Sealing validation protocol, report and support data must be attached to the technical documentation for early notified body approval.
• The medical device must be labeled with appropriate information indicating that it is sterile. The label should also include details about the sterilization method used, and any instructions for use or handling to maintain sterility.

I3CGLOBAL Consultants play a significant role in assisting low risk class 1 sterile medical device manufacturers with the CE certification process. These devices, under the EU MDR, require indepth technical documentation.  We help manufacturers develop a regulatory strategy that aligns with the specific requirements for sterile devices under the MDR by identifying applicable regulations, guidance documents, and standards.

• We consultants prepare the technical documentation file ensuring it meets MDR requirements and submit to NB for review.
• Ensure proper clinical evaluation plan, literature search and Clinical Evaluation Report (CER) complying with MDR Article 61 and Meddev 2.7/1 rev 4 guidelines.
• Review, guide on critical topics such as sterilisation and sterile pouch sealing and its validation studies.
• Review and support in the risk analysis process and benefit risk estimation as per ISO 14971
• Guide the manufacturer through the performance and functional testing.
• Liaison between the manufacturer and the Notified Body, during technical file review process.

I3CGLOBAL Consultants provide comprehensive support to reusable surgical instruments manufacturers ensuring complete compliance and documentation for CE Certification.