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.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
Read more订阅生命科学领域的最新动态
专家观点直达您的收件箱——选择您的兴趣。
绝无垃圾邮件。随时取消订阅。
