Four questions to prepare your MD for market
Four key questions will help you determine your approach
You’ve established that your project qualifies as a medical device (MD). Here are some factors that will help define the course of your project.
What is the class of my MD?
Medical devices are divided into different risk classes: I, IIa, IIb, III.
- Regardless of the risk class, the safety and clinical performance requirements are the same, but the conformity assessment procedure will be adapted to the risk class.
- For low-risk devices (class I), the manufacturer carries out self-certification. For other devices, conformity assessment is carried out by a third party called a notified body.
- You must identify your device’s risk class as soon as possible and contact a notified body if necessary.
- To determine your product’s risk class, see Annex VIII of Regulation 2017/745.
What are the priority target markets?
- It is recommended to identify from the outset which markets you wish to target first, in order to integrate all the corresponding regulatory requirements into your device’s design phase.
- CE marking valid in Europe may be recognised for market authorisation in certain third countries, but many countries have their own regulations which must be complied with. If you want to market in the United States, for example, you will have to follow the American regulations.
To find out more: https://frenchhealthcare.fr/
Does my business model involve reimbursement by the Health Insurance Fund?
- The french national health insurance fund covers medical devices either by including them on a reimbursement whitelist called the "List of Reimbursable Products and Services" (LPP), or through their use during a professional procedure.
- Registering a procedure as an official medical procedure and registering a product on the LPP requires a prior assessment by the Haute Autorité de Santé. If your product is likely to be covered in this way, study the extent to which it is possible, during your clinical trials for CE marking, for you to produce the data that will be requested by the HAS for reimbursement authorisation.
Is my product a breakthrough innovation or an or incremental one?
If your medical device is a breakthrough innovation, you can request support from the ANSM's Innovation and Guidance Desk for regulatory aspects, data requirements and procedures related to the development of your device.
Access the ANSM's GIO (Innovation and Guidance Desk)