EU Notified bodies..'I just dropped in to see what condition my condition was in'

As we all congratulate DARE for becoming the 6th Notified Body (NB) for the (EU) 2017/745 medical device regulations it is time to ponder just how much progress has really been made.

Many posts on linked in are stating that we are now on the right path forward to addressing the capacity issues associated with the regulation and I tend to agree that this (a 6th NB) is clearly a positive step forward from the NB's and of course the designating authorities.

What is not clear is that everyone understands and pays attention to the importance of the designation scope and conditions that exist.

After the DARE announcement this morning I began to analyse all of the codes that are now covered by the six.

The analysis concludes several things

1. Conditions apply to all notified bodies with the least number of conditions being placed on BSI and TUV Sud (3 conditions) and the most on IMQ (15 conditions). The total number of conditions imposed amounts to 43 to date.
2. The options of all conformity assessment routes (Annex X, Annex IX(I), Annex IX(II), Annex XI(A) and Annex XI(B) ) are not consistently available for the same device groups across the notified bodies.
3. Active implantable devices - Only two notified bodies (BSI and TUV SUD) are able to cover the full compliment of active-implantable device group codes MDA0102 - MDA0104
4. There are only 14 device groups out of 44 where all 6 notified bodies are designated
5. Non-active implants - Only 3 notified bodies can fully cover cardiovascular, vascular and neurovascular implants (BSI, DEKRA and TUV SUD) although it is fair to mention that TUV Rheinland only have a restriction for devices introduced using open heart surgery
6. Non-active Implants - Only 3 notified bodies can fully cover orthopaedic joint replacement implants (BSI, DEKRA and TUV SUD)
7. The most consistent conditions relate to sterilisation and Annex XVI products. For sterilisation it appears that TUV SUD have the widest compliment of sterilisation technologies to cover (aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), sterilisation with hydrogen peroxide, sterilisation with liquid chemical sterilising agents, thermic sterilisation with dry heat and the least covered being DARE ( limited to ethylene oxide gas sterilisation and radiation sterilisation).

Whilst there is definitely a positive feel to the progression of notified bodies to address their non-conformities from the designation process it is becoming apparent that many of the NB's now coming onboard are doing so with limited or restricted designation scopes.

It is essential that manufacturers begin to evaluate their product portfolios and assign the appropriate NBOG coding structure to their devices and compare these with the NB designation scope to avoid the notified body being unable to process you MDR application.

In order to assign the appropriate coding please review the NBOG codes and ensure you consider

• The device code (MDA / MDN). This covers the product family, product intended use and product range.
• The horizontal technical competence codes (MDS)
• The manufacturing codes (MDT)

If you are interested in my detailed analysis and would also like a copy of the spreadsheet feel free to contact me at [email protected]