Last week there were already some rumors about Instituto Italiano del Marchio di Qualita S.P.A. (IMQ) being designated for the Medical Devices Regulation (EU) 2017/745 (MDR). Now this designation has been published in Nando. IMQ is the fourth Notified Body (NB) to be designated, after BSI Assurance UK Ltd, TÜV SÜD Product Service GmbH and DEKRA Certification GmbH. Given Brexit-related uncertainties in the UK and their potential impact for BSI, IMQ is for now the third EU-based option for companies who want to certify under the MDR.

Scope

IMQ is certainly not a full scope NB, although they will probably be capable of servicing many companies. Not all active and non-active implantable devices can be certified, and for the two non-active implantable groups (osteo- and orthopedic implants as well as dental implants and dental material), Class III devices are excluded. Most Class III non-active, non-implantable devices are also included. Interestingly for small and highly specialized companies, most available products can rely on Annex X for certification by IMQ. Annex IX and Annex XI are also covered for most product groups.

Currently IMQ is not designated for the IVDD and therefore it is not likely they will be designated for the IVDR soon.

Certification under the MDR

In August IMQ is closed for summer vacations and therefore it was not possible to ask them when they would expect to see the first audits starting. However, from comments from other NBs this may take until November or December of 2019.

First pattern emerges

Looking at the scopes of TÜV SÜD, DEKRA and IMQ, a first pattern regarding availability emerges.

• TÜV SÜD has almost full exclusivity for active implantable devices.
• Available coverage for active non-implantable devices for imaging, monitoring and/or diagnosis and for active non-implantable therapeutic devices and general active non-implantable devices is much better; all three designated NBs can do that.
• For non-active implants the spread is more mixed, and breast implants can only go to TÜV SÜD, and only for the Annex IX procedure.
• Non-active, non-implantable devices are also covered well, although the Annex X procedure is hardly covered for this group of NBs.
• For the codes related to “devices with specific characteristics” the picture is more scattered. MDS 1002 – devices manufactured utilizing tissues or cells of human origin, or their derivatives – is limited to TÜV SÜD and DEKRA only for devices manufactured utilizing human serum albumin (HSA).
• Reusable surgical instruments can be certified by all three European NBs, which is a good thing considering they need to be certified by May 2020.
• Finally, most specific processes and technologies are also covered by all three NBs.

In conclusion: all types of medical devices can now be certified by these NBs, but not for all procedures. Only TÜV SÜD is capable of certifying a manufacturer with a broad scope of devices. For implants the options remain limited.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Additional European MDR-related information from Emergo by UL:

• European MDR resource center for medical device companies
• Whitepaper: Understanding the European MDR