Module 17 2024

Howard Dobbs

04/12/2024

MDR Article 16.3 QMS for relabellers and repackers Distributors and importers who relabel or repack shall … have in place a QMS that includes procedures which ensure that: - the translation of information is accurate - the relabelling and repackaging are performed by means that preserve the original condition of the device (repackaging must not be of “ poor quality or untidy” !) - the distributor or importer is informed of any corrective action taken by the OEM. • In other words, the relabeller and/or repacker must have a QMS which includes at least the above 3 things.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

15

MDR Article 16.4 Inform the manufacturer and the competent authority At least 28 days before making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities described in 2(a) or 2(b) shall inform the manufacturer and the competent authority of the MS in which they plan to make the device available … and upon request shall provide the manufacturer and the competent authority with a sample or mock-up ... including any translated label or IFU. Also, shall submit to the competent authority a certificate issued by a NB … attesting that the QMS of the distributor or the importer complies with the QMS requirements listed in Article 16.3.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

16

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