Regulatory Open Forum

Hello, everyone,

I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical device non-sterile in the UK. However, due to market demand, our distributor wants to offer the device sterilized to hospitals.

From a quality and regulatory perspective, what steps should we consider if this is feasible? Should we approve all potential sterilization providers and include them in our critical supplier list? Additionally, would this necessitate registering a new product with the MHRA, indicating it can also be sold as sterile, potentially requiring a different GMDN code?

Any guidance or shared experiences on this matter would be immensely appreciated.

Thank you very much.

Hello, everyone,

I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical device non-sterile in the UK. However, due to market demand, our distributor wants to offer the device sterilized to hospitals.

From a quality and regulatory perspective, what steps should we consider if this is feasible? Should we approve all potential sterilization providers and include them in our critical supplier list? Additionally, would this necessitate registering a new product with the MHRA, indicating it can also be sold as sterile, potentially requiring a different GMDN code?

Any guidance or shared experiences on this matter would be immensely appreciated.

Thank you very much.

Please note that the regulatory pathway for marketing a sterile device has extensive requirements for validation of the sterilization process, validation of the package and validation of the product functionality after exposure to the sterilant as well as additional manufacturing controls.  

Hello, everyone,

I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical device non-sterile in the UK. However, due to market demand, our distributor wants to offer the device sterilized to hospitals.

From a quality and regulatory perspective, what steps should we consider if this is feasible? Should we approve all potential sterilization providers and include them in our critical supplier list? Additionally, would this necessitate registering a new product with the MHRA, indicating it can also be sold as sterile, potentially requiring a different GMDN code?

Any guidance or shared experiences on this matter would be immensely appreciated.

Thank you very much.

Further details (e.g., UK-based manufacturer vs. based outside the UK; device class and type; marketing based on CE mark or instead on an actual UKCA mark; Northern Ireland marketing status, etc., etc.) of your case need to be known in order to answer definitively.  But ultimately in general, changing a UK-registered device from non-sterile to sterile constitutes a significant design change (device design and process design) that, per the UK MDR, must be documented and processed accordingly. In a nutshell, this first and foremost means using the quality management system's properly established design/development change control process.  That process (if properly established) systematically determines the many required changes in the quality management system documentation and in the regulatory documentation and regulatory submissions/updates.  When deciding what particular document/regulatory changes are needed, steer clear of the temptation to just rely on feel or opinion.

Please note that the regulatory pathway for marketing a sterile device has extensive requirements for validation of the sterilization process, validation of the package and validation of the product functionality after exposure to the sterilant as well as additional manufacturing controls.  

Hello, everyone,

I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical device non-sterile in the UK. However, due to market demand, our distributor wants to offer the device sterilized to hospitals.

From a quality and regulatory perspective, what steps should we consider if this is feasible? Should we approve all potential sterilization providers and include them in our critical supplier list? Additionally, would this necessitate registering a new product with the MHRA, indicating it can also be sold as sterile, potentially requiring a different GMDN code?

Any guidance or shared experiences on this matter would be immensely appreciated.

Thank you very much.

Thank you all for this valuable information. We are a foreign company and the sterilization is planned to be done in UK  by the distributor.

And this where I'm bite confused. does this process allow in UK or should we send the device sterile from our site?

Thank you in advance for your reply.

Rgds,

Further details (e.g., UK-based manufacturer vs. based outside the UK; device class and type; marketing based on CE mark or instead on an actual UKCA mark; Northern Ireland marketing status, etc., etc.) of your case need to be known in order to answer definitively.  But ultimately in general, changing a UK-registered device from non-sterile to sterile constitutes a significant design change (device design and process design) that, per the UK MDR, must be documented and processed accordingly. In a nutshell, this first and foremost means using the quality management system's properly established design/development change control process.  That process (if properly established) systematically determines the many required changes in the quality management system documentation and in the regulatory documentation and regulatory submissions/updates.  When deciding what particular document/regulatory changes are needed, steer clear of the temptation to just rely on feel or opinion.

Please note that the regulatory pathway for marketing a sterile device has extensive requirements for validation of the sterilization process, validation of the package and validation of the product functionality after exposure to the sterilant as well as additional manufacturing controls.  

Hello, everyone,

I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical device non-sterile in the UK. However, due to market demand, our distributor wants to offer the device sterilized to hospitals.

From a quality and regulatory perspective, what steps should we consider if this is feasible? Should we approve all potential sterilization providers and include them in our critical supplier list? Additionally, would this necessitate registering a new product with the MHRA, indicating it can also be sold as sterile, potentially requiring a different GMDN code?

Any guidance or shared experiences on this matter would be immensely appreciated.

Thank you very much.