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Medical Device Regulation (MDR) Article 16 Certification

Ensure repackaged products or translated labels meet the requirements of MDR Article 16 with assessment and certification services from SGS.

Importers or distributors of medical devices that repackage products or translate labels need to meet EU MDR Article 16 requirements by certifying their quality management system (QMS). This is separate from ISO 13485/ISO 9001 or CE/UKCA certification.

As a Notified Body, we provide assessments and certification to confirm your compliance with MDR Article 16 requirements.

Why choose MDR Article 16 certification services from SGS?

We can help you to:

  • Confirm that your packaging and labels meet MDR Article 16 requirements
  • Acquire MDR Article 16 certification
  • Ensure transparency and communicate the legal manufacturer of your medical devices
  • Ensure free trade in local EU markets

Why SGS?

We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

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