Hi folks,

The MDD allows a “legal manufacturer” (i.e. not the actual manufacturer) to "place a medical device on the market".

Question: does the MDD obligate the “legal manufacturer” to disclose the actual place where the device was manufactured???

Thanks.

Asherlee

Hi folks,

The MDD allows a “legal manufacturer” (i.e. not the actual manufacturer) to "place a medical device on the market".

Question: does the MDD obligate the “legal manufacturer” to disclose the actual place where the device was manufactured???

Thanks.

AsherleeAt least to your Notified Body. See Article 11 point 10.

The manufacturing locations are disclosed in the technical file (part A). If manufacturing is outsourced then the supplier is disclosed. The labeling requirements require that the legal manufacture list their name and address. That address is not necessarily the location of actual manufacturer.

There is the so called OBL (own brand labelling) manufacturer.

An OBL appears as manufacturer of the device accordnig to the MDD.

For third parties there is no evidence, that the manufacturer is not the OEM (original equipment manufacturer). And there is no need for it. The OBL has the full responsibility after the MDD as any other manufacturer (OEM or not).
And there is no difference to a large company with several manufacturing plants spread over the world.

In the MDD there is no requirement to disclose the manufacturing plant to third parties. The notified body has to ensure that the manufacturing complies with the requirements of the MDD (Annex II, IV, V or VI). It is not an issue where the manufacturing was done.

There is a recent article from UK MHRA (http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007500.pdf)
and a legal opinion by EDMA (http://www.edma-ivd.be/Position_papers/OBL_Ann_A.doc) according to OBL manufacturing

HTH~ghw