Guidelines for Changing Sterilization Methods for the European Market
I recently came across several requests on sterilization development for the European market. While each project requires unique regulatory development considerations, the following is a general overview on this topic for the European market.
There are situations when changing the sterilization method of a single-use medical device is required or provides a benefit. Some situations that may warrant this include:
(1) Cost advantages and simplicity of having all products sterilized with same method
(2) Convenience of sterilizing products in-house and simplified supply chain
(3) Improving or eliminating material or residual issues
If the medical device is sold into the European Market (EU), then the device must have a CE mark from an approved EU notified body. There is a formal process for this called the European Medical Devices Directive (MDD 93/42/EEC).
If the single-use device already is already CE marked, then the medical device company should approach the appropriate Notified Body and explain the situation. Additionally, the company should request the notified body to review the sterilization aspects of the technical file and design file. At minimum, this will need to include:
- Description of the sterilization method change and risk analysis
- ISO sterilization guideline to which you will be adhering (i.e. ISO 14937, ISO 11135 etc)
- Brief description of the installation qualification and validation summary
- Sterilization method must have a SAL of 10-6 or better
- Process Validation Report with physical performance qualification and microbiological performance qualification
- Sterilization facility certified by a Notified Body (ISO 9001/2, ISO 13485 / 13488)
- Details of the effect of the sterilization change and verification that the device performance or efficacy is unchanged
The biocompatibility testing of the device will need to be repeated, and a new packaging validation must be conducted. This sterilization change will also require a label change or modification. The best strategy is an upfront meeting with your Notified Body before you actually begin the transition to get their specific input on what is required.
A solid understanding of how the European Medical Devices Directive will impact the sterilization regulatory pathway of specific products, will help companies assess realistic development timeline and associated development / regulatory costs. The best way to approach this is to consult with sterilization service companies who are familiar with the European process.