4 Questions to help me prepare my DM for the market

Four key questions will help you structure your approach

You have established that your project qualifies as a medical device (MD), here are some elements that will help in structuring your project.

What class is my DM?

Medical devices are divided into different risk classes: I, IIa, IIb, III.

  • Whatever the risk class, the safety and clinical performance requirements are the same, but the conformity assessment procedure will be adapted according to the risk class.
  • For low-risk devices (class I) the manufacturer proceeds with self-certification. For other devices conformity assessment is carried out by a third party called a notified body.
  • You must identify as soon as possible what the risk class of your device will be, and contact a notified body if necessary.
  • To determine the risk class of your product, consult the annex VIII of regulation 2017/745.

What are your priority target markets?

  • It is advisable to identify from the outset the markets you wish to target as a priority, in order to integrate all the corresponding regulatory requirements right from the design stage of your device.
  • The CE mark valid in Europe may be recognized for marketing in certain non-EU countries, but a large number of countries have their own regulations with which you will need to comply. If you wish to market in the USA, for example, you will need to follow US regulations.

For more information: https://frenchhealthcare.fr/

Does my business model involve reimbursement by health insurance?

  • Health insurance covers medical devices either via their inclusion on a positive reimbursement list called the "Liste des produits et prestations remboursables" (LPP), or via their use during a professional act.
  • The inclusion of a procedure in the nomenclature of medical acts and the inclusion of a product on the LPP require prior assessment by the Haute Autorité de Santé. If your product is likely to be reimbursed in this way, study the extent to which it is possible for you to produce, during your clinical trials for CE marking, data that will be requested by the HAS for reimbursement.

Is my product a breakthrough or incremental innovation?

If your medical device constitutes a breakthrough innovation, you can request support from ANSM's innovation and guidance desk regarding regulatory aspects, data requirements and procedures related to the development of your device.

Access the ANSM's GIO (guichet innovation et orientation)