The client
A client developing a rugged autoinjector. Most injectors live in a bathroom cabinet or a fridge. This one needed to be carried around and still work first time after months of rough handling. We’ve kept the client and the application anonymous.
The brief
Develop the device from initial concept through to the Article 117 notified body opinion. If you haven’t come across Article 117: a pre-filled autoinjector is regulated as a medicine, but the marketing authorisation needs a notified body’s opinion on the device part of the product. It catches a lot of teams out because it tends to surface late in a programme, when the design is already fixed. Here it was in the plan from the start.
What we did
Concept work and early prototypes first. Ruggedness was the main design driver, so each round of prototypes got tested well beyond normal bench conditions before we moved on.
We wrote the device technical documentation as the project went along, structured around what a notified body reviewer would want to see for Article 117. That sounds obvious but it rarely happens in practice, and it made the submission a case of pulling together evidence we already had.
Where it stands
The project has gone from initial concept through to Article 117, with the ruggedness proven along the way.
If you’re developing a combination product, Article 117 is worth planning for early. It’s a lot cheaper to design for it than to react to it. We’re always happy to have a call to talk it through. Book a free call.