Medizinische Verpackungslösungen

Official data sheet containing data regarding chemical, physical and other properties of a substance.

REACH is the European Community Regulation on chemicals and their safe use. Only chemical substances that have been registered can be sold within the EU.

This means that all materials or their ingredients (e.g. monomers in polymers) have to be registered for purpose “medical device”.

RAPIDS contains information with respect to material components and applicable laws and standards

Examples: Food Contact, Latex, BSE/TSE, DMF, EP, USP etc.

Drug master files are prepared for drug products or primary packaging materials for drug products. They are submitted to the US Food and Drug Administration (FDA).

For the registration of medical devices, the DMF is of great importance for plastic materials and is generally required by our customers.

For further information and link to the database go to http://www.fda.gov/cder/dmf/

If no DMF can be provided, the plastic materials have to comply with the “food contact materials and consumer products” requirements (see point 5)

e.g. 2002/72/EC guidance relating to plastic materials and articles intended to come into contact with foodstuffs or 21CFR Parts 170-190 FDA
this information is mandatory for all plastic materials without a DMF; all additives / colours should also be suitable for food contact materials and / or consumer products

Restriction of the use of certain hazardous substances in electrical and electronic equipment according to 2002/95/EC;
mandatory for all electric components

Statement that the material is biocompatible (contact to skin) in compliance with ISO 10993. If available, please provide the respective statements for Japan.

Statement whether the product contains materials of animal origin.

Statement that the material is not of animal origin or does not contain animal components which are relevant to BSE / TSE.

If the material contains such substances provide a statement that they were inactivated with reference to the relevant guidelines.

Statement that the material does not contain any latex additives or had no contact to latex.

Statement whether the material contains phthalates. DEHP must be considered in the statement as this is a specific Canadian requirement.

Please specify the concentration, if the material contains DEHP.

Precise statement if the material is derived from BPA or contains Bisphenol A (specific Canadian requirement).

Please specify the concentration, if the material contains BPA.