Question: Are silica gel packets within scope of the European Union (EU) Medical Device Regulation (MDR)?
Answer: Silica gel packets are an interesting case. According to the EU MDR:
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.
Devices, or those parts thereof or those materials used therein that:
- are invasive and come into direct contact with the human body,
- (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
- transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.
In theory, if a device meets these criteria, it is within the scope of the EU MDR.
Silica gel packets may not look as though they are in scope of EU MDR because they keep product containers dry and prevent moisture build-up. However, section 11.7 of the EU MDR, Infection and microbial contamination, stipulates the following: “Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimize the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.”
In essence, if a product meets the criteria for Article 10.4.1, then section 11.7 is applied and the packaging, including silica gel packets, would be considered part of the finished device until it is opened and used. The same logic applies to section 11.4, which concerns plastic packaging on sterile devices.
This article is current as of 2019-08-02.