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Regulatory Focus™ > News Articles > 2019 > 12 > MDCG Offers New Guidance on MDR, IVDR Sampling, Codes

MDCG Offers New Guidance on MDR, IVDR Sampling, Codes

Posted 11 December 2019 | By Zachary Brennan 

MDCG Offers New Guidance on MDR, IVDR Sampling, Codes

The Medical Device Coordination Group (MDCG) on Wednesday released two new guidance documents: One document to define the requirements of sampling Class IIa and Class IIb devices under the Medical Devices Regulation (MDR) and Class B and Class C devices under the In Vitro Diagnostic Regulation (IVDR), and one document on the different MDR codes.

The first 8-page guidance defines and further elaborates on the sampling criteria and use of such criteria for drawing up and maintaining a sampling plan. The guidance includes specifics on sampling prior to the issuance of quality management system (QMS) certificates, sampling during surveillance and qualitative sampling criteria. It also offers more depth on assessing technical documentation.

For sampling prior to issuing a QMS certificate, the notified body should select at least one representative device per each generic device group (i.e. set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner) covered by a Basic UDI-DI and assess the technical documentation for the device(s) selected.

For Class IIa devices and Class B IVDs, the NB would also review the technical documentation of at least one representative device per category of devices (the category of devices is defined as the relevant MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185).

After the QMS certificate is issued, the notified body is expected to review the technical documentation each year.

“This means that at least one device per each category, in case of Class IIa and Class B devices, and at least one device per each generic device group, in case of Class IIb and Class C devices, should be sampled and the relevant technical documentation assessed between the issue of a certificate and its expiry date,” the MDCG says.

The NB should also ensure that the number of devices sampled is proportionate to the total number of devices contained in the certificate, the guidance adds, noting that it is expected that 15% (although for the first certification cycle under MDR/IVDR, the 15% may be decreased to a minimum of 5%) of devices from each category and generic device group covered in the certificate will be sampled over five years.

As far as the depth and extent of the technical documentation assessment, the MDCG says that it will be the same for Class IIa/IIb devices and Class B/C IVDs as for Class III and Class IIb implantable and Class D IVDs.

“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,” the guidance says.

The guidance also further discusses how NBs shall draw up sampling plans and keep them up to date.

MDR Codes

The MDCG also released guidance on Wednesday regarding codes that are primarily used to designate authorities to define the NB scope of designation and so NBs can describe the individual qualification of its staff members and the qualification required for assessing a device.

“These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes and the assignment of codes to a device is not always straightforward. However, the notified body’s system needs to ensure, in all cases, that the authorisation of personnel and team allocation for the conformity assessment of a device ensures adequate knowledge and expertise,” the guidance says.

The MDCG also explains in detail the types of codes that can be assigned to different devices.

MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

MDCG 2019-14 Explanatory note on MDR codes

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