CE Approval for new intended use

The intended use and intended user of a product are central to a product’s risk assessment. The required documentation and regulations differ depending on:

the risk classification
the intended use
the intented user/target group

Even products that are approved and well documented must be reapproved, if the intended use or user group for the device changes.

Background

Innoventa Medica wished to certify an existing product with a new intended purpose and target audience. The product had already been on the market for many years and had both been utilized for its original intended use, as well as in an off-label format.

Considering that the new intended purpose and patient group were different and required different documentation and test data, the documentation had to be revised. In addition, while the original documentation was good, it was in a format that focused on the requirements of the outdated MDD, not the MDR.

Product risk class

Class IIb and a Class IIb implant

Company size

3 employees
2 external consultants, incl. RAQA

Task

Insource technical documentation from the contract manufacturer
Transition documentation from MDD to MDR
Locate and communicate with the Notified Body
Submit documentation for approval

Goals

Update and align the technical files with the MDR in a manner that takes into consideration:
- the required level of documentation
- market history
- company size
Submission to and approval of technical files by Notified Body.

Approach

Innoventa Medica had already started the process of redocumenting their product when they discovered that they needed additional resources to complete the task.

RAQA was brought in to support the staff and draft the missing documents. Innoventa Medica was fully involved, maintaining full ownership of the process.

We started by gathering and scanning or retyping all of the documentation and uploading it to an initial platform to create a complete overview. We discussed and agreed upon the level of the documentation needed to fulfil the regulations. Throughout the review process, we ensured that the focus of the documentation was on the new target group and new intended purpose of the product. The existing technical files were updated and new files were created to comply with the MDR.

“Laura has been helping us both with regards to establishment of the technical files and certification of our QMS system to the MDR standard. She has a good relationship with our customers and is trusted to participate in meetings with our customers and our staff.”

– Niels Erik Holm (CEO), Innoventa Medica

Results

The QMS system was updated according to the MDR and all of the new and revised documentation were entered into the QMS. The technical files were subsequently certified under the MDR by the Notified Body.

The products have now been CE marked as per the MDR requirements where the new intended purpose and patient group are included. Now there is focus on maintenance, improvements, new products, as well as new markets.

Continued collaboration

All post-market activities and ongoing updates are being performed in cooperation by Innoventa Medica and RAQA. Meanwhile, Innoventa Medica is busy exploring new ideas and investigating new products, with advisory services from RAQA as required.

“We have been working with RAQA since 2021, and Laura has been a major contributor in helping us obtain MDR approval of our Class IIb implant products. She is a trustworthy person who seeks to simplify issues, and she takes a pragmatic view when needed.”

– Niels Erik Holm (CEO), Innoventa Medica

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