Exporting Orthopedic Supports to the EU: What to Check Before Printing Labels

Can you design the packaging for knee, back or ankle supports first, then add CE marking and an EU representative's details later?

Serena's advice: establish product status and legal responsibilities before approving artwork. Incorrect identities, intended-purpose statements or compliance claims can affect the whole market-entry plan.

1. Is the product a medical device?

“Support” or “brace” is a product description, not a regulatory classification. Assess intended purpose, claims, design and mode of action before deciding whether EU MDR applies. Not every brace is a medical device or automatically Class I. Non-medical products need a separate assessment of applicable rules.

2. Identify the legal manufacturer

The production factory, exporter and brand owner may be different entities. Establish who places the device on the market under its name or trademark and who carries manufacturer responsibilities. Labels, the declaration of conformity and technical documentation should agree.

An importer or distributor selling under its own brand may assume manufacturer obligations. MDR Article 16 provides an exception for specific agreements where the manufacturer is identified on the label and remains responsible. A private-label contract alone does not establish that the exception applies. EU MDR: Articles 2 and 16

3. Key checks before artwork approval

• Product identity: confirm the name, model and identification details match the supplied product.
• Manufacturer and EU representative: verify the manufacturer's name and registered address. For a non-EU manufacturer, establish the applicable EU authorized representative arrangement and provide its name and registered address as required.
• Importer: provide the required information on the device, packaging or accompanying documentation. An additional label must not obscure the manufacturer's information.
• Conformity and traceability: check CE marking, medical-device identification, batch or serial information, and applicable UDI requirements and implementation arrangements.
• Use and safety: check intended purpose, warnings, limitations, storage conditions and relevant dates as applicable. Keep labels and instructions consistent.
• Language: check destination Member State requirements; English is not automatically sufficient throughout the EU.

This is a pre-print checklist, not a complete universal labelling template. Information placement, instructions-for-use requirements and exceptions depend on the device. EU MDR: Articles 10, 11, 13, 20 and 27; Annex I, Section 23

4. CE marking and representative details are not decorative

CE marking requires the applicable conformity assessment and EU declaration of conformity, not merely a test report or service agreement. Ordinary Class I devices that are non-sterile, have no measuring function and are not reusable surgical instruments generally do not require notified-body involvement. Not every brace needs the same type of “CE certificate”.

Use a notified-body number only where applicable. Do not print SUNGO or another company's name as the authorized representative without confirming the formal mandate, exact legal entity and covered products. EU MDR: Articles 11, 19, 20 and 52

5. Prepare these documents before revising labels

Share product images and models, intended purpose, manufacturer and brand-owner details, the existing declaration of conformity and applicable certificates, draft packaging and instructions, and intended sales countries.

We can help clarify product status, responsibilities and the points requiring review. First establish who is responsible, what is sold and where—then decide what belongs on the packaging.

Explore EU MDR support → · Discuss your labels with Serena

Specific requirements are subject to product assessment and the competent authority's current regulations.
Official EU MDR text

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