The Medical Devices Introductory Course 2020

Custom-Made Devices Article 52.8 (MDD Article 11)

• Before placing on the market the M must comply with all Annex XIII requirements and draw up a statement which must include: – Confirmation that the devices conform with the General Safety and Performance Requirements in so far as possible – The applicable doctor and patient information • The label must include the words “Custom-made device” (Annex I.23.2(p)) • These devices do not bear the CE mark • For class III custom-made implantable devices the M must have a QMS as specified in Annex IX Ch I or Annex XI Part A • Note: For devices for clinical investigations see Article 62.4(l)

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The Organisation for Professionals in Regulatory Affairs

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Applies to devices which are already CE marked Systems and Procedure Packs Systems & Procedure Packs Article 22 (MDD Article 12)

• The “M” must draw up a statement that he has 1) verified the mutual compatibility of the devices, 2) properly packaged the devices with appropriate IFU and 3) applied appropriate controls and inspections • The “M” does NOT apply an additional CE Mark, but does put his name and address on the pack Steriliser of Systems or Packs • The “M” must follow either Annex IX or XI Part A

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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