Revision of MDCG 2019-13 released

Regulatory Affairs Medical Devices In Vitro Diagnostics

Monday, 23 December 2024

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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

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On December 17th, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the 2019 guidance on sampling of Regulation (EU) 2017/745 (MDR) Class IIa/Class IIb and Regulation (EU) 2017/746 (IVDR) Class B/Class C devices for the assessment of the technical documentation. This revision addresses the fraction of devices within 1 sampling plan that need to be assessed, taking into account the validity of their certificate.

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Revision of MDCG 2019-13 released | QbD Group Regulatory Update

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MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

What was updated in MDCG 2019-13 Rev.1?

This revision is limited to an update of footnote 10.

Notified bodies may assess the technical documentation of certain (in vitro diagnostic) medical devices through sampling after issuing the certificate i.e., during surveillance. This approach applies to devices from the same manufacturer if they belong to the same category of devices (Class IIa MD, Class B IVD) or the same generic device group (Class IIb MD, Class C IVD), as notified bodies can group such devices into sampling plans.

MDCG2019-13 clarified that 15% of devices from each category and each generic device group covered by the certificate are expected to be sampled during its validity period, which can extend up to 5 years.

The original footnote 10 added that for the first certification cycle, this 15% could be decreased to a minimum of 5%. The revised version of footnote 10 now states that “the 15% may be decreased to a minimum of 5% until the overall ongoing revision of this guidance document will be published”. This update removes the limitation that the reduced percentage could only be applied during the first certification cycle.

What does this mean to you?

MDCG 2019-13 Rev.1 is important for all manufacturers with a range of (in vitro diagnostic) medical devices that belong to the same sampling plan. The manufacturer must always ensure that the technical documentation for each device is compliant and up-to-date. However, having devices in sampling plans can significantly speed up the time to market for new devices if the technical documentation can be assessed after issuing the certificate.

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