On 14 September, two new guidelines, MDCG 2022-15 and MDCG 2021-22, were published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The guidelines are drafted in collaboration with interested parties represented in the various groups and are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonized implementation of the legislation.
MDCG Guideline 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect of their quality management system. The document applies to notified bodies that have lawfully issued certificates under the IVDD, regardless of whether or not those notified bodies have applied for designation or are designated under the IVDR (see MDCG 2019-10 rev.1) as long as the respective authority responsible for notified bodies has the right to and does monitor the notified body’s activities under Article 110(3) IVDR.
MDCG Guideline 2021-22 rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022) was issued in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 on IVD. For class D devices, the Article mentioned, establishes the conditions to be applied by the notified body to determine whether it has to consult the expert panel on the performance evaluation report of the manufacturer. These conditions are:
(1) the absence of common specifications for the class D device in
question,
AND
(2) where it is also the first certification for that type of device.
This guidance provides clarification on the meaning of these conditions and on the corresponding procedures to be followed by the notified body. Itcovers topics including:
· What is the meaning of “the first certification for that type of device” in accordance with Article 48(6) of Regulation (EU) 2017/746?
· What procedure should a notified body follow to determine whether a given certification is the first for that type of device?
· How should the notified body indicate the type of device in its submission to the IVD expert panel?
· What is the meaning of the phrase “where no CS are available” in Art 48(6)?
· If a notified body identifies that a consultation of an expert panel is currently ongoing for that type of device, what should it do regarding the certification process?
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