The conformity assessment procedure is the regulatory path that allows the manufacturer (or the notified body if applicable) to assess the conformity of a device before it is placed on the market.
There are several possible path, depending on the class of the device.

Have you already determined the class of your device? If yes,  head over to to article 52 of the MDR  to see the choices available to you.

It is important to keep in mind that, regardless of the conformity assessment procedure you choose, there will always be two essential components necessary to prove the conformity of your devices:

  • One that relates to the product: the technical documentation (TD), the aim being to prove that the products are safe and effective
  • The other which relates to your internal organisation: the establishment of a quality management system (QMS), the aim being to prove that the safety and performance of the devices are maintained over time

In reality, it is the level of involvement of the notified body that differs depending on the procedure chosen:

  • Annex IX? The notified body carries out a complete review of the QMS, including the design history file, as well as an assessment of the TD
  • Annex X? The notified body assesses the TD, and checks that the type (representative sample of the device) has been manufactured in accordance with the DT. This annex must be combined with Annex XI part A or B.
  • Annex XI part A? The notified body checks that the QMS is such that it ensures that the devices conform to the type and with the applicable provisions of the Regulation. This QMS review excludes the design history file.
  • Annex XI part B? The notified body examines each device individually to verify the compliance of the devices with the type and with the applicable provisions of the Regulation.

To choose the right path for your product and your organisation, you must ask the right questions: Is your product likely to evolve? Do you have data regarding the design of your product?

The choice of the conformity assessment procedure is an important strategic decision, not to be taken lightly! And if you need any additional support, contact us 😊