Regulatory Open Forum

Hi Anon

There are a couple of areas of MDR (&IVDR) where the EMDN code is referenced: for Registration of devices (needed as part of assignment of UDI-DI, Annex VI part B; from Art. 29 & 33; as mentioned already) and they are referenced under the MDCG Guidance on Grouping & Sampling (MDCG 2019-13) for grouping of devices. The latter guidance comes from the requirement under Article 52 regarding conformity assessment, and the requirement for assessment of technical documentation of 'at least one representative device' per group.

Therefore, the device codes are used by the Notified Bodies at the point of Application to support grouping of devices appropriately (in order to then plan an appropriate conformity assessment; see requirement Annex IX 2.1 2^nd sub-bullet), and in the case of devices that require a product specific certificate, that these codes are assigned appropriately; linking to the requirement for Basic UDI-DI on these certificates.

Therefore, Yes, EMDN codes are needed, as you need them at the time of Application to a NB; the NB has to show that they have met all the requirements of verifying the application (inc appropriate grouping, classification etc) prior to commencing any work (Annex VII 4.2 & 4.3). 

• A Manufacturer's legislatively-mandated use of the nomenclature codes is limited to the aforementioned Article 26 mandate tethered to the intent of the EUDAMED database.
• While certain Manufacturers' technical documentation is subject to a conformity assessment of at least one representative device for each generic device group / category of devices [Article 52(4) & (6)], it remains true that this does not obligate the Manufacturer to assign an EMDN code for that purpose.
• Instead, it is the NB (if any is involved) who is obligated to perform such sampling of the technical documentation.  For that, MDCG 2019-13 is a guidance intended for NBs to help NBs in deciding how to choose such sampling.  That guidance aims to leverage the EMDN coding to help the NB meet this obligation.  But that guidance is not a legislative mandate for the NB, and certainly not for a Manufacturer.
• Guidelines like MDCG-13 are just that: guidelines.  They are not legislation, and we should all be careful not to ascribe legislative authority to such guidance.  For example, MDCG-13 (as with other MDCG guidelines) remind us of this in their disclaimer, "...The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding..."
• I'm unaware of any particular obligations in EU MDR Annex VII 4.2 or 4.3 that mandate a Manufacturer to assign EMDN codes for the purpose of an NB's technical documentation assessment. Instead, these Annex VII provisions are standard obligations to be met by the NB and that govern the NB's control of the pre-conformity assessment application step. 

Hi Anon

There are a couple of areas of MDR (&IVDR) where the EMDN code is referenced: for Registration of devices (needed as part of assignment of UDI-DI, Annex VI part B; from Art. 29 & 33; as mentioned already) and they are referenced under the MDCG Guidance on Grouping & Sampling (MDCG 2019-13) for grouping of devices. The latter guidance comes from the requirement under Article 52 regarding conformity assessment, and the requirement for assessment of technical documentation of 'at least one representative device' per group.

Therefore, the device codes are used by the Notified Bodies at the point of Application to support grouping of devices appropriately (in order to then plan an appropriate conformity assessment; see requirement Annex IX 2.1 2^nd sub-bullet), and in the case of devices that require a product specific certificate, that these codes are assigned appropriately; linking to the requirement for Basic UDI-DI on these certificates.

Therefore, Yes, EMDN codes are needed, as you need them at the time of Application to a NB; the NB has to show that they have met all the requirements of verifying the application (inc appropriate grouping, classification etc) prior to commencing any work (Annex VII 4.2 & 4.3). 

• A Manufacturer's legislatively-mandated use of the nomenclature codes is limited to the aforementioned Article 26 mandate tethered to the intent of the EUDAMED database.
• While certain Manufacturers' technical documentation is subject to a conformity assessment of at least one representative device for each generic device group / category of devices [Article 52(4) & (6)], it remains true that this does not obligate the Manufacturer to assign an EMDN code for that purpose.
• Instead, it is the NB (if any is involved) who is obligated to perform such sampling of the technical documentation.  For that, MDCG 2019-13 is a guidance intended for NBs to help NBs in deciding how to choose such sampling.  That guidance aims to leverage the EMDN coding to help the NB meet this obligation.  But that guidance is not a legislative mandate for the NB, and certainly not for a Manufacturer.
• Guidelines like MDCG-13 are just that: guidelines.  They are not legislation, and we should all be careful not to ascribe legislative authority to such guidance.  For example, MDCG-13 (as with other MDCG guidelines) remind us of this in their disclaimer, "...The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding..."
• I'm unaware of any particular obligations in EU MDR Annex VII 4.2 or 4.3 that mandate a Manufacturer to assign EMDN codes for the purpose of an NB's technical documentation assessment. Instead, these Annex VII provisions are standard obligations to be met by the NB and that govern the NB's control of the pre-conformity assessment application step. 

Hi Anon

There are a couple of areas of MDR (&IVDR) where the EMDN code is referenced: for Registration of devices (needed as part of assignment of UDI-DI, Annex VI part B; from Art. 29 & 33; as mentioned already) and they are referenced under the MDCG Guidance on Grouping & Sampling (MDCG 2019-13) for grouping of devices. The latter guidance comes from the requirement under Article 52 regarding conformity assessment, and the requirement for assessment of technical documentation of 'at least one representative device' per group.

Therefore, the device codes are used by the Notified Bodies at the point of Application to support grouping of devices appropriately (in order to then plan an appropriate conformity assessment; see requirement Annex IX 2.1 2^nd sub-bullet), and in the case of devices that require a product specific certificate, that these codes are assigned appropriately; linking to the requirement for Basic UDI-DI on these certificates.

Therefore, Yes, EMDN codes are needed, as you need them at the time of Application to a NB; the NB has to show that they have met all the requirements of verifying the application (inc appropriate grouping, classification etc) prior to commencing any work (Annex VII 4.2 & 4.3).