MDD ER 7.5, "phthalate test"? Aspiration tips

zeypzeyn

Starting to get Involved
#1
Hello,

I have a question related to the MDD ER 7.5;

The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.

If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.


So do we need to perform test for aspiration tips that includes polyoxymethylene material in order to prove it doesnt contains phtalate.

Thank you very much.
 
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planB

Trusted Information Resource
#2
zeypzeyn,
testing would be tedious and prone to not finding all the needles in the haystack. Better try to get declarations from your suppliers of materials (raw materials, additives, process aids etc) where they certify absence of phthalates. Here is an example from BASF ( I am not affiliated to BASF).
HTH,
 

Ronen E

Problem Solver
Staff member
Moderator
#3
So do we need to perform test for aspiration tips that includes polyoxymethylene material in order to prove it doesnt contains phtalate.
1. Are these aspiration tips intended to administer and/or remove substances to or from the body?

2. Polyoxymethylene (POM or Acetal) doesn't typically contain phthalates. The concern is usually with PVC and sometimes other polymers. If you only use POM with no additives your risk level is probably low to begin with. Certification from your raw material supplier is probably enough, provided that you don't add any other substances during processing.

3. "Phthalates" is unnecessarily broad. When you ask the supplier for certification, you should refer them specifically to the listed types of phthalates. Please note that Directive 67/548/EEC has been replaced by Regulation (EC) No 1272/2008.
 
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