EMERGO SUMMARY OF KEY POINTS:

• The first implementing act related to the Regulations for Medical Devices and IVDs is now open for consultation.
• The significantly changed list of product codes for IVDs is heavily discussed and it is not certain this list will be the final version.
• The high level of granularity in these tables may complicate audits.

The first implementing act related to the European Medical Devices Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR) is now open for public consultation. Implementing acts are Regulations by the European Commission setting out the practicalities of higher-level legislation. This first act is on the most pressing subject at this time: the Notified Body (NB) product codes for medical devices and IVDs. These codes are used to categorize the fields of expertise of the NBs and thereby define their scope.

The draft implementing regulation is in one document, while the annexes with the draft codes are in a second document. The five recitals introduce the concept of product codes: They provide a multi-dimensional typology of devices to ensure that a designated NB is competent to handle devices they are required to assess. Because it is expected that all NBs requesting designation for the IVDR will also request designation for the MDR, the two lists are combined in one document.

The three articles are short and clear. They set out that the list of product codes for medical devices can be found in Annex I and the codes for the IVDs are listed in Annex II. The codes should be used by NBs for specifying the devices in their applications for designation.

Annexes

Annex I lists five tables with 44 product codes (55 under the MDD) for medical devices:

1. Active implantable devices (e.g. MDA 0101 Active implantable devices for stimulation / inhibition / monitoring)
2. Active non-implantable devices for imaging, monitoring and/or diagnosis (e.g. MDA 0201 Active non-implantable imaging devices utilizing ionizing radiation)
3. Active non-implantable therapeutic devices and general active non-implantable devices (e.g. MDA 0301 Active non-implantable devices utilizing ionizing radiation)
4. Non-active implants and long term surgically invasive devices (e.g. MDN 1101 Non-active cardiovascular, vascular and neurovascular implants)
5. Non-active non-implantable devices (e.g. MDN 1201 Non-active non-implantable devices for anesthesia, emergency and intensive care)

This Annex also lists two tables with a total of 27 horizontal codes (9 under the MDD):

1. Devices with specific characteristics (e.g. MDS 1101 Devices incorporating medicinal substances)
2. Devices for which specific technologies or processes have been used (e.g. MDT 2001 Devices which require metal processing)

Annex II lists eight tables with 35 product codes (32 under the IVDD) for IVDs:

1. Devices intended to be used for blood grouping (e.g. IVR 0101 Devices intended to be used for blood grouping with regard to ABO system [A (ABO1), B (ABO2), AB (ABO3)])
2. Devices intended to be used for tissue typing (e.g. IVR 0201 Devices intended to be used for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration (HLA A, B, DR))
3. Devices intended to be used for markers of cancer and non-malignant tumors (e.g. IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer)
4. Devices intended to be used for human genetic testing (e.g. IVR 0401 Devices intended to be used in screening / confirmation of congenital / inherited disorders)
5. Devices intended to be used to determine markers of infections / immune status (e.g. IVR 0501 Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents)
6. Devices intended to be used for non-infectious pathologies, physiological markers, and disorders / impairments (except human genetic testing) (e.g. IVR 0606 Devices intended to be used for non-infectious disease staging)
7. Devices which are controls without a quantitative or qualitative assigned value (e.g. IVR 0701 Devices which are controls without a quantitative assigned value)
8. Class A devices in sterile condition (e.g. IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746)

This Annex also lists four tables with a total of 65 horizontal codes (6 under the IVDD):

1. In vitro diagnostic devices with specific characteristics (e.g. IVS 1001 Devices intended to be used for near-patient testing)
2. In vitro diagnostic devices for which specific technologies have been used (e.g. IVT 2004 In vitro diagnostic devices which require non-metal non-mineral processing such as textiles, rubber, leather, paper)
3. In vitro diagnostic devices which require specific knowledge in examination procedures (e.g. IVP 3010 In vitro diagnostic devices which require knowledge regarding microscopy)
4. In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification (e.g. IVD 5210 - Zika virus (Zika fever))

Audits

One question remains: Will these NBOG codes continue to be used to define sampling plans as currently required under the MDD? This could create a problem in the IVD sector, which now has more than 100 codes. Some fields of expertise are rare, like the Zika virus, and an expert in this subject may not have a full-time job reviewing these types of devices. It is not clear if during an audit all these experts need to be readily available.

As an illustration: If the same granularity would have been used for medical devices there would have been separate product codes for orthopaedic hip implants, knee implants, shoulder implants, etc.  

Public consultation and formal publication

This draft is open for public consultation, meaning that parties involved may submit comments on this proposal, until October 25, 2017. Stakeholders’ organizations will of course provide feedback, but individual companies may reflect on the effects these tables may have on their specific portfolios.

Publication is expected on November 26, 2017, which is also the first date by which NBs can express their interest in designation. They can only do that by referring to these codes. This timeline therefore creates a situation where consultation may lead to changes that create a huge challenge for NBs requesting designation, or the consultation process is only a formality where industry is forced to accept the proposal without any significant changes.

It may take until at least September 2018 before the first NB is designated, and the last NB having its first designation audit may have to wait until summer 2019. European industry participants and observers may therefore have to wait a while before it becomes clear which notified bodies will be designated, and what will be their scope.

Related European medical device regulatory resources from Emergo:

• European CE Marking strategy for medical device companies
• European CE Marking support for IVD manufacturers
• On-site Medical Devices Regulation (MDR) training for manufacturers
• Whitepaper: European MDR timelines and strategies
• Webinar: How to select and change your Notified Body