The MDCG published two important guidance documents this afternoon.
Firstly, an Explanatory note on MDR Codes, i.e. MDA/MDN, MDS, MDT was published. These Codes are used by the manufacturer when applying to the Notified Body (NB) for the assessment of its devices. The verification of the MDR Codes by the NB is performed in order to confirm that the NB has been indeed accredited for this specific code and has available resources to carry out the relevant conformity assessment activities (”feasibility evaluation”).
The second guidance document is relevant for MDR and IVDR manufacturers of upper class devices, i.e. MDR Class IIa / Class IIb and IVDR Class B / Class C devices submitting their technical documentation to the Notified Body that will assess it accordingly.
”Article 52(4) and (6) of the MDR and Article 48(7) and (9) of the IVDR establish the need to assess the technical documentation of at least one representative device per generic device group (for Class IIb and Class C) and for each category of devices (for Class IIa and Class B) prior to issuing the certificate.”
The MDCG guidance defines the below concepts, which are not clarified in the Regulations:
3.1. Category of devices: category of devices should be understood as the relevant MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185 on the codes for the designation of notified bodies.
3.2. Generic device group*: is to be understood:
– in respect of the MDR**as the 4th level of the European Nomenclature on Medical Devices (EMDN) ** (i.e. combination of one letter plus 6 digits), and
– in respect of the IVDR as the 3rd level of the EMDN (i.e. combination of one letter plus 4 digits respectively) in combination with the most appropriate IVP code.
3.3. Device range: device range is to be understood as all “device categories” for Class IIa and Class B devices and all “generic device groups” for Class IIb and Class C devices covered in a certificate.
3.4. Device: device should be understood as the device(s) associated with one Basic UDI-DI*.
3.5. QMS certificates: QMS certificates are EU quality management system certificates (MDR and IVDR), EU quality assurance certificates (MDR) and EU production quality assurance certificates
For a full overview of the footnotes(*), please click here.
The MDCG also enlists Quantitative Sampling Criteria in the process of
- Sampling prior to issuing a QMS certificate
- Sampling during surveillance
As well as Qualitative Sampling Criteria and depth of the assessment, which shall be for the Class IIa / IIb and Class B / Class C devices the same as the depth of assessment carried out for Class III and Class IIb implantable and Class D devices:
This means that the technical documentation of a device shall be assessed against all General Safety and Performance Requirements (Annex I) and requirements of Annex II and III. Records of the assessment shall be prepared which allow a third party to understand the functionality of the device and all aspects of the assessment including judgements made by the assessor.
It should be taken into account that every device (i.e. Basic UDI-DI) might include different variants, models or sizes. In that case, the review of the technical documentation will also include the assessment of how the differences among these have been addressed in the technical documentation and whether all of them are in line with the relevant requirements.
The MDCG also addresses requirements of technical documentation review for other types of devices, for example Class IIb implantable devices.
It is also stated that in order to fulfil the legal requirements, the reporting requirements established in Section 4.6. of Annex VII will apply.
Lastly, the MDCG touched upon the sampling plan that should be kept up-to-date. ”The outcome of the screening of relevant sources of scientific and clinical data and post-market information relating to the scope of their designation, or the review of vigilance data should be taken into account.”
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