EMERGO SUMMARY OF KEY POINTS:

• Notified Body designation codes for the Regulations are now officially released.
• There are some minor differences in the list for medical devices.
• The list for IVDs has been reduced by 20 codes.
• Manufacturers can now list the NBOG codes that are relevant for them.

Notified Bodies (NB) that want to be designated under the Medical Devices Regulation (MDR) or In-Vitro Diagnostics Regulation (IVDR) must list their scope on their application forms. The scope can be defined by referring to codes. These codes were published in draft in September 2017 and were open for public consultation. On November 27, 2017 the codes were officially published. Now that the codes are official, manufacturers can investigate which codes are relevant for them. Using these codes, firms can ask their current NBs about their intended scope or make a profile of potential NB partners.

Designation codes for medical devices

Some significant differences can be seen between the earlier public consultation version and the final version of the list of codes.

For medical devices the main differences are editorial and the 71 codes are basically the same as in draft form. However, between the draft version and the final version codes 1002 (Devices manufactured utilizing tissues or cells of human origin, or their derivatives) and 1003 (Devices manufactured utilizing tissues or cells of animal origin, or their derivatives) switched places. This is a significant difference that may easily be overlooked, so let’s hope no NBs got the wrong box checked on their application form.

Designation codes for IVDs

For IVDs the differences are more significant. A total of 20 previously defined codes have been dropped, leaving a total of 80. Simplifications have been achieved for blood grouping and tissue typing, but the main differences can be seen in the codes for “devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification.” That table lost 18 codes (e.g. Zika). This was probably done due to challenges created for NBs to have experts in all these fields available for relatively rare tests.

Notified Bodies

NBs can now express their interest in designation under the MDR or IVDR. Member States and the European Commission may then review these applications and perform audits. So far no firm facts have been published so it is impossible to say which NBs have applied or what their scope is. It is not even possible to know if new organizations have expressed interest in becoming NBs under the MDR.

The Commission may publish information any time in the future. Emergo will of course share that with industry.