Module 17 2024

Howard Dobbs

04/12/2024

MDR Article 22.5 Systems and procedure packs

The system or procedure packs … shall not themselves bear an additional CE marking , but they shall bear the name, registered trade name/mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted … System or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I.

31

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

31

MDR Article 23.1 Parts and components

Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose , shall ensure that the item does not adversely affect the safety and performance of the device …

In other words, in this case the natural or legal person does not assume the obligations of the manufacturer.

32

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

32

<#>

16