Module 18 2021

05/02/2021

Device-Drug Products

MDR Article 1(8)

• All devices incorporating as an integral part a substance which, if used separately, can be considered to be a medicinal product and which has • action ancillary to that of the devices shall be assessed and authorized in accordance with MDR

The Organisation for Professionals in Regulatory Affairs

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MDD Vs MDR Classification rule

MDD Annex IX – Rule 13 All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III. All devices incorporating, as an integral part, a human blood derivative are in Class III.

MDR Annex VIII – Rule 14 All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of that directive, and that has action ancillary to that of the devices, are classified as Class III

The Organisation for Professionals in Regulatory Affairs

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