I have a question on the MDR exemption - we are contract manufacturers for components in US and shipped to an OEM in US who ultimately assemble these components along with the drug cartridge to make a finished device and responsible for the commercial distribution too.
The OEM has given us a document to be co-signed by both the OEM and we, the contract manufacturer that would be forwarded to the FDA seeking MDR reporting exemption for us (contract manufacturer) and also mentions that the OEM will be solely responsible for handling the MDRs.
We expressed that being a contract manufacturer for components, the MDR guidance document,
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#whomust
automatically excludes us as the scope applies to “All manufacturers of finished medical devices commercially distributed in the U. S., including foreign manufacturers who export devices to the U.S., are required to comply with the MDR regulation”.
Could you pls advice if I am right in my assumption ?
I’m going from memory, but I believe you are incorrect. The definitions of “manufacturer” in 21CFR 820 and 21CFR 803 are different. MDR compliance is referenced to the 21CFR 803 definition, under which both a responsible Manufacturer and a contract manufacturer (that ships essentially finished devices, without consideration of labeling, packaging and if applicable, sterilization) are subject to MDR requirements.
The only way around this, to my knowledge, is to have a written MDR-responsibility agreement between the Manufacturer and the contract manufacturer, and to have that agreement approved by FDA as an exemption to 21 CFR 803.19(b). It sounds as if this is exactly the course that your customer wants you to follow.
However, you say you make “components”. If the things you ship are not regarded as medical devices by FDA at time of entry into USA, presumably you are not a contract manufacturer as FDA defined in either 21CFR 820 or 21CFR 803, but instead are a component maker as defined in 21CFR 807.
There have been several Warning Letters pertaining to this; the one that I recall at the moment was issued to Laboratorios B. Braun, and is at
http://www.fda.gov/ICECI/Enforcement.../ucm265582.htm
. If in fact you are a contract manufacturer as defined in 21CFR 820 and 803, that Warning Letter comprehensively covers your question.