Medical Packaging Regulations

The UK Medical Devices Regulations 2002 is the primary UK legislation governing medical devices, including packaging. Based on EU MDR 93/42/EEC, but diverging post-Brexit.

• Packaging must protect the safety, sterility, and integrity of the device.
• Must be labelled correctly, including name, batch/serial number, and manufacturer details.
• Packaging of sterile devices must maintain sterility until point of use.

Specialist packaging that GWP Group provides, including protective cases and Correx, can be provided to comply with these regulations. Labeling of information is typically the responsibility of the device manufacturer (the information supplied to GWP Group if we are to add this must be accurate and correct). GWP does not provide packaging for sterile products.

The Medicines Act 1968 and Human Medicines Regulations 2012 is the UK law regulating medicinal products (e.g., pharmaceuticals, biologicals).

• Packaging must prevent contamination and degradation.
• Inner and outer packaging must include essential label elements (strength, batch, expiry, etc).
• Tamper-evident features required for some categories.

GWP Group does not supply primary packaging for medicines or pharmaceutical products. The accuracy and presence of information on packaging (labelling requirements) is typically the responsibility of the product manufacturer, and not GWP Group. GWP Group can provide secondary packaging (e.g. general transit packaging) that helps prevent product degradation, such as temperature controlled options, and can include tamper evident features if required.

UK medicines and Healthcare products Regulatory Agency (MHRA) is the guidance on what must appear on medicinal packaging.

Packaging must include:

• Product name (generic + brand)
• Active substance
• Route of administration
• Expiry date, batch number, storage instructions
• Braille for name and strength (EU/UK requirement)
• Design must minimise risk of medication error

The inclusion and accuracy of any information included on packaging GWP Group supplies is the responsibility of our customer. GWP Group can print the specific information as requested, but is not able to determine or advise on what should be included.

The Consumer Protection Act 1987 is the UK legislation on product safety.

• Packaging that fails to protect against misuse, leakage, or contamination could render the product “unsafe”.
• Misleading or unclear packaging may be considered noncompliant under this Act.

GWP Group does not provide primary packaging for medicines or pharmaceutical products. Secondary packaging can be supplied to help contain leakage and prevent contamination. Misleading claims are the responsibility of the customer, and not GWP Group as packaging manufacturers. GWP Group prints information, marketing messages and graphics as per customers supplied artwork, and cannot be held responsible for the accuracy of such information.

ISO 11607-1:2019 is the global standard for packaging of sterile medical devices.

• Defines requirements for materials, design, and performance of packaging.
• Packaging must maintain sterility under shipping and storage conditions.
• Requires validated sealing processes and shelf-life testing.

GWP Group does not manufacture or provide primary packaging with a requirement for maintaining sterility. Larger medical devices, for which GWP Group can supply packaging, are typically sterilised before and after use by the end user.

ISO 13485:2019 is the international QMS standard specifically for medical device manfuacturers.

• Ensures consistent production and control of medical packaging.
• Packaging manufacturers supplying sterile medical devices must often be certified to this standard.

GWP Group does not manufacture or provide primary packaging with a requirement for maintaining sterility. Larger medical devices, for which GWP Group can supply packaging, are typically sterilised before and after use by the end user.

ISO 15223-1:2021 is the global standard for symbols used on medical packaging.

• Promotes language-independent labelling through standardised symbols.
• Widely required for CE/UKCA-marked products in both UK and global markets

The responsibility for accurate and suitable information, printed or otherwise added to packaging we supply, is the responsibility of our customers. GWP Group will add information based on artwork supplied by customers for their specific packaging lines, and cannot be held responsible for the accuracy or suitability of this.

The EU Medical Device Regulation 2017/745 is the regulation that governs all medical devices in the EU.

• Packaging must protect device integrity, sterility, and traceability.
• Requires UDI (Unique Device Identifier) labelling for many device classes.
• Exporters must ensure packaging meets EU MDR labelling and documentation standards if selling into EU markets).

GWP Group does not manufacture or supply packaging that maintains sterility. GWP can however supply packaging that maintains integrity and can assist in traceability. GWP Group can assist with the addition of UDI (Unique Device Identifiers) on packaging if requested to do so. Labelling and documentation requirements are the responsibility of the customer.

The FDA 21 CFR Part 820 is the US QMS regulation for medical device manufacturing.

• Requires validated packaging and labelling systems for sterile devices.
• Mandates device traceability and labelling controls.
• Relevant to UK exporters targeting the US.

GWP Group can assist UK manufacturers exporting to the US with these requirements, but cannot supply packaging specifically for maintaining sterility or help with labelling and informational requirements.

ASTM D4169 is the US standard for simulated distribution testing.

• Used to verify that medical packaging maintains product integrity under transportation stress (vibration, drop, temperature)
• Often paired with ISO 11607 shelf-life testing.

GWP Group can arrange for testing (e.g. vibration, temperature changes) with a number of third party testing providers if required. Partners include TUV SUD and ISTA. GWP can also supply samples for our customers to arrange their own testing as required.

The EN 868 Series is the EU-aligned standards supporting ISO 11607.

• Provides specifications for specific packaging materials (e.g., pouches, trays, films).
• Required in some EU procurement frameworks.

GWP Group does not manufacture or supply packaging that falls under this category.

The GS1 Standards Unique Device Identification is the global system for identifying medical products.

• UDI barcode labels are required on packaging for devices sold in EU, US, and other global markets.
• GS1 is the most widely accepted issuing body.

GWP Group can print UDI barcodes onto packaging, providing they are supplied to us by the customer. Labelling and informational requirements are the responsibility of the product manufacturer, not GWP Group.

ISO 15378:2017 is the global standard that specifies requirements for QMS’ for manufacturers of primary packaging materials used for medicinal products (e.g., bottles, blister packs, vials, syringes).

• Are produced under strict GMP conditions.
• Consistently meets safety, quality, and regulatory standards critical to protecting medicines.
• Maintain traceability, contamination control, and integrity so the packaging does not compromise the medicines safety or effectiveness.

GWP Group does not manufacture or supply primary packaging for medicinal products.