Module 17 2024

Howard Dobbs

04/12/2024

MDR Article 23.2 Parts and components

An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.

In other words, in this case the natural or legal person shall assume the obligations of the manufacturer.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

33

Conclusions

The obligations of the manufacturer will apply to you if you: • make a device available on the market under your own name (i.e., you are an Own Brand Labeller or a Virtual Manufacturer) • change the intended purpose of a CE marked device • modify a CE marked device (except if you just relabel or repack) The obligations of manufacturers may apply to you if you: • supply a system or procedure pack • supply parts or components

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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